L-PZQ ODT in Schistosoma Infected Children

An Open Label, Phase III Efficacy and Safety Study of L-PZQ ODT in Schistosoma Infected Children 3 Months to 6 Years of Age, Including a 2:1 Randomized, Controlled Cohort of Schistosoma Mansoni Infected Children 4 to 6 Years of Age Treated With L PZQ ODT or Commercial PZQ (Biltricide®)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03845140

Enrollment

288

Registered

2019-02-19

Start date

2019-09-02

Completion date

2021-10-11

Last updated

2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schistosomiasis

Keywords

Schistosomiasis, Children, L-praziquantel, Biltricide®

Brief summary

The study would evaluate the safety and efficacy of L-praziquantel orodispersible (L-PZQ ODT) tablets in Schistosoma infected children aged 3 months to 6 years.

Interventions

DRUGL-PZQ ODT 50 mg/kg

Participants received single oral dose of L-PZQ ODT 50 mg/Kg on Day 1.

DRUGBiltricide®

Participants received single oral dose of Biltricide® 40 mg/kg on Day 1.

DRUGL-PZQ ODT 60 mg/kg

Participant received single oral dose of L-PZQ ODT 60 mg/kg on Day 1.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Months to 6 Years

Healthy volunteers

Inclusion criteria

* Age of the participant is 4 to 6 years of age (Cohorts 1 and 4), 2 to 3 years of age (Cohorts 2 and 4) 3 to less than 24 months of age (Cohorts 3 and 4) * Participants are; Schistosoma (S.) mansoni positive (Cohorts 1, 2, and 3); diagnosis defined as positive egg counts in stool greater than or equal to ( \>=) 1 egg per 1 occasion) according to World Health Organization (WHO) classification \[1\]: light (1 to 99 eggs per gram of feces), moderate (100 to 399 eggs per gram of feces) and heavy (\>= 400 eggs per gram of feces) infections; S. haematobium positive (Cohort 4); diagnosis defined as positive egg counts in urine (\>= 1 egg per 10 milliliter(mL) urine) according to WHO classification (Prevention and Control of Schistosomiasis and Soil Transmitted Helminthiasis. WHO Technical Report Series No. 912. WHO, Geneva, Switzerland, 2002).light (less than (\<) 50 eggs per 10 mL of urine) and heavy (\>=50 eggs per 10 mL of urine) infections * Participants have a minimum body weight of 8.0 Kilograms (Kg) in 2 to 6 years of age children and 5.0 Kg in 3 months to \< 24 months of age infants and toddlers * Parent's or guardian/legally authorized representative's ability to communicate well with the Investigator and his/her delegate, to understand the protocol requirements and restrictions, and to be willing to have their children comply with the requirements of the entire study, that is: * To be examined by a study physician at screening and 17 to 21 days after treatment * To provide stool samples at screening and 17 to 21 days after treatment * To provide urine samples at screening and 17 to 21 days after treatment * To provide venous blood samples for laboratory assessments * To be housed in the clinic for 12 to 24 hours * To provide venous blood samples for pharmacokinetics (PK) assessments (for participants in the PK subset) * Participants have a minimum hemoglobin level of 10 gram per deciliter

Exclusion criteria

* Participants with following medical conditions are excluded from the study; Findings in the clinical examination and/or laboratory safety examination on the treatment day, that in the opinion of the Investigator constitute a risk or a contraindication for the child's participation in the study or that could interfere with the study objectives, conduct or evaluation. This includes but is not restricted to bacterial or viral infections, such as dysentery, gastroenteritis, ascites, jaundice, etc.; Participants with seizures and/or medical history of seizures and/or other signs of potential central nervous system involvement; Participants with known cysticercosis, or with signs or symptoms (for example: subcutaneous nodules) suggestive of cysticercosis; Participants with an acute infection or other acute illness within the 7 days prior to study screening; Debilitating illness such as tuberculosis, malnutrition, etc. * Treatment with PZQ within the 4 weeks prior to the study screening * Concomitant treatment (within 2 weeks prior to enrollment) with medication that might affect the metabolism of PZQ, such as certain anti epileptics (for example: carbamazepine or phenytoin), glucocorticosteroids (for example: dexamethasone), chloroquine, rifampicin or cimetidine (see Biltricide® Summary of Product Characteristics \[SmPC\]) * Treatment within the 2 weeks prior to the study screening with anti malarial medications * For infants and toddlers being breast fed, treatment of the mothers/wet nurses with PZQ in the 3 days prior to PZQ ODT administration * Participation in any clinical study within 4 weeks prior to administration of PZQ ODT, or anticipated at any time until completion of the End of study visit * Participants with marked increases of the liver enzymes: alanine aminotransferase and/or aspartate aminotransferase above 3 times the upper limit of normal (ULN); total bilirubin level above 1.5 times the ULN * Participants with hepatosplenic schistosomiasis * Fever, defined as temperature above 37.5 degree Celsius axillary or oral mixed S. haematobium and S. mansoni infections

Design outcomes

Primary

Measure	Time frame	Description
Cohort 1a and Cohort 1b: Number of Participants With Clinical Cure Determined by Kato-Katz Method	at Week 3	Clinical cure was defined as no parasite egg in the stool at Week 3 as determined by the Kato-Katz method. Number of participants with clinical cure were reported.

Secondary

Measure	Time frame	Description
Cohort 4a and Cohort 4b: Egg Reduction Rate (Percent [%]) Determined by Urine Filtration Technique	Pre-treatment, Weeks 3 and 5 post-treatment	Percentage of reduction in group mean egg count was calculated as relative difference between the post-treatment arithmetic mean egg count and pre-treatment arithmetic mean egg count at baseline count, (pre-treatment mean egg count minus post-treatment mean egg count divided by pre-treatment mean egg count) \*100. Egg counts were determined by the urine filtration technique.
Cohort 1a, Cohort 1b, Cohort 2, and Cohort 3: Number of Participants With Clinical Cure Determined by Point-of-Care Circulating Cathodic Antigen (POC-CCA) Test	at Week 3	Clinical cure is defined as absence of test line in the POC-CCA test cassette (that is no Schistosoma antigens detected). Number of participants with clinical cure were reported.
Cohort 2 and Cohort 3: Number of Participants With Clinical Cure Determined by Kato-Katz Method	at Week 3	Clinical cure was defined as no parasite egg in the stool at Week 3 as determined by the Kato-Katz method. Number of participants with clinical cure were reported.
Cohort 4a and Cohort 4b: Number of Participants With Clinical Cure Determined by Urine Filtration Technique	Week 3 and Week 5	Clinical cure was defined as no parasite egg in the urine samples at follow up as determined by the urine filtration technique. Number of participants with clinical cure were reported.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs	up to Day 40	Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs were defined as those events with onset dates/time occurring after study intervention administration or events that worsen after study intervention administration. TEAEs included serious TEAEs and non-serious TEAEs. Treatment-related TEAEs: reasonably related to the study intervention.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale	up to Day 40	Severity of TEAEs were graded using Qualitative Toxicity Scale, as follows: Mild: Participant is aware of the event or symptom, but the event or symptom is easily tolerated; Moderate: Participant experiences sufficient discomfort to interfere with or reduce his or her usual level of activity; Severe: Significant impairment of functioning: the participant is unable to carry out his or her usual activities. Number of participants with TEAEs by severity were reported.
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin	Baseline, Day 1	Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Change from baseline in hematology parameter: erythrocytes mean corpuscular hemoglobin at Day 1 were reported.
Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration and Hemoglobin	Baseline, Day 1	Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: erythrocytes mean corpuscular HGB concentration and hemoglobin. Change from baseline in hematology parameters: erythrocytes mean corpuscular HGB concentration and hemoglobin at Day 1 were reported.
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume	Baseline, Day 1	Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes mean corpuscular volume. Change from baseline in hematology parameter: erythrocytes mean corpuscular volume at Day 1 were reported.
Change From Baseline in Hematology Parameter: Erythrocytes	Baseline, Day 1	Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes. Change from baseline in hematology parameter: erythrocytes at Day 1 were reported.
Change From Baseline in Hematology Parameters: Leukocytes and Platelets	Baseline, Day 1	Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: leukocytes and platelets. Change from baseline in hematology parameters: leukocytes and platelets at Day 1 were reported.
Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Baseline, Day 1	Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: hematocrit, lymphocytes/leukocytes, mixed cells/leukocytes, neutrophils/leukocytes. Change from baseline in hematology parameters: hematocrit, lymphocytes/leukocytes, mixed cells/leukocytes, neutrophils/leukocytes at Day 1 were reported.
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase and Aspartate Aminotransferase	Baseline, Day 1	Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: Alanine Aminotransferase and Aspartate Aminotransferase. Change from baseline in chemistry parameters: Alanine Aminotransferase and Aspartate Aminotransferase at Day 1 were reported.
Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin	Baseline, Day 1	Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: bilirubin, creatinine and direct bilirubin. Change from baseline in chemistry parameters: bilirubin, creatinine and direct bilirubin at Day 1 were reported.
Cohort 1a, Cohort 1b, Cohort 2 and Cohort 3: Egg Reduction Rate (Percent [%]) Determined by Kato-Katz Method	Pre-treatment, Week 3 post-treatment	Percentage of reduction in group mean egg count was calculated as relative difference between the post-treatment arithmetic mean egg count and pre-treatment arithmetic mean egg count at baseline count, (pre-treatment mean egg count minus post-treatment mean egg count divided by pre-treatment mean egg count) \*100. Egg counts were determined by the Kato-Katz method.
Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen	Baseline, Day 1	Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: glucose, urea and urea nitrogen. Change from baseline in chemistry parameters: glucose, urea and urea nitrogen at Day 1 were reported.
Change From Baseline in Chemistry Parameter: Total Protein	Baseline, Day 1	Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: total Protein. Change from baseline in chemistry parameter: total Protein at Day 1 were reported.
Change From Baseline in Urinalyses Parameter: Specific Gravity of Urine	Baseline, Day 1	Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameters: specific gravity. Change from baseline in urinalyses parameter: specific gravity Day 1 was reported.
Change From Baseline in Urinalyses Parameter: Potential of Hydrogen (pH) of Urine	Baseline, Day 1	Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameter: pH. Change from baseline in urinalyses parameter: pH at Day 1 was reported.
Change From Baseline in Urinalyses Parameter: Urobilinogen	Baseline, Day 1	Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameter: urobilinogen. Change from baseline in urinalyses parameter: urobilinogen at Day 1 were reported.
Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure	Baseline, Week 3	Diastolic blood pressure and systolic blood pressure were measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital signs: diastolic blood pressure and systolic blood pressure at Week 3 were reported.
Change From Baseline in Vital Signs: Pulse Rate	Baseline, Week 3	Pulse rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital sign: pulse rate at Week 3 was reported.
Change From Baseline in Vital Sign: Respiratory Rate	Baseline, Week 3	Respiratory rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital sign: respiratory rate at Week 3 was reported.
Change From Baseline in Vital Signs: Temperature	Baseline, Week 3	Temperature was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital sign: temperature at Week 3 was reported.
Number of Participants With Reaction to Study Intervention Administration	Day 1	Reaction to study intervention administration were recorded to describe tolerability as assessed by nurse/site staff for all children enrolled in the study. Reactions categorized as spitting, crying, diarrheas, sleepiness, abdominal pain, fever, vomiting and other. Number of participants with reaction to study intervention administration reported.
Cohort 1a, Cohort 1b, Cohort 4a and Cohort 4b: Palatability Assessment Based on Visual Analog Scale (VAS) Score	Day 1	Palatability of the study intervention was assessed using a human gustatory sensation test (100-millimeter \[mm\] visual analog scale \[VAS\]) incorporating a facial hedonic scale, where lower score (0) indicates not acceptable/not liked at all and higher score (100) indicates very acceptable/liked very much.
Maximum Observed Plasma Concentration (Cmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose	Cmax was obtained directly from the plasma concentration versus time curve.
Time to Reach Maximum Plasma Concentration (Tmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose	Tmax was obtained directly from the plasma concentration versus time curve.
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose	Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.
Change From Baseline in Chemistry Parameter: C Reactive Protein	Baseline, Day 1	Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: C reactive protein. Change from baseline in chemistry parameter: C reactive protein at Day 1 were reported.

Countries

Côte d’Ivoire, Kenya

Participant flow

Participants by arm

Arm	Count
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	100
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	50
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	30
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	18
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	30
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.	60
Total	288

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005
Overall Study	Participant travelled outside study area	0	1	0	0	0	0

Baseline characteristics

Characteristic	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Total	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg
Age, Continuous	5.4 years STANDARD_DEVIATION 0.69	4.8 years STANDARD_DEVIATION 1.54	5.1 years STANDARD_DEVIATION 1.51	4.6 years STANDARD_DEVIATION 1.49	1.4 years STANDARD_DEVIATION 0.43	3.0 years STANDARD_DEVIATION 0.59	5.5 years STANDARD_DEVIATION 0.83
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	100 Participants	288 Participants	60 Participants	30 Participants	18 Participants	30 Participants	50 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Sex: Female, Male Female	52 Participants	137 Participants	28 Participants	9 Participants	11 Participants	16 Participants	21 Participants
Sex: Female, Male Male	48 Participants	151 Participants	32 Participants	21 Participants	7 Participants	14 Participants	29 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	0 / 100	0 / 50	0 / 30	0 / 18	0 / 30	0 / 60
other Total, other adverse events	66 / 100	31 / 50	20 / 30	14 / 18	9 / 30	28 / 60
serious Total, serious adverse events	0 / 100	0 / 50	0 / 30	0 / 18	0 / 30	1 / 60

Outcome results

Primary

Cohort 1a and Cohort 1b: Number of Participants With Clinical Cure Determined by Kato-Katz Method

Clinical cure was defined as no parasite egg in the stool at Week 3 as determined by the Kato-Katz method. Number of participants with clinical cure were reported.

Time frame: at Week 3

Population: Modified intent to treat analysis population (mITT) included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment. Only 1 participant from Cohort 1b was lost to follow-up and was imputed as non-cured.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Cohort 1a and Cohort 1b: Number of Participants With Clinical Cure Determined by Kato-Katz Method	86 Participants
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Cohort 1a and Cohort 1b: Number of Participants With Clinical Cure Determined by Kato-Katz Method	39 Participants

Secondary

Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ

Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.

Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose

Population: PKP analysis population is a subset of the SAF population and consisted of all participants who received at least one dose of active IMP and provide at least one measurable post-dose concentration. Here Number Analyzed signifies those participants who were evaluated in specified categories.

Arm	Measure	Group	Value (MEAN)	Dispersion
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	R-PZO	1080 hoursnanogram per milliliter (hng/mL)	Standard Deviation 1036
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	S-PZO	2.84 hoursnanogram per milliliter (hng/mL)	Standard Deviation 0.9072
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	S-PZO	1240 hoursnanogram per milliliter (hng/mL)	Standard Deviation 1124
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	R-PZO	184 hoursnanogram per milliliter (hng/mL)	Standard Deviation 150
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	R-PZO	2720 hoursnanogram per milliliter (hng/mL)	Standard Deviation 1718
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	R-PZO	NA hoursnanogram per milliliter (hng/mL)	—
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	R-PZO	1190 hoursnanogram per milliliter (hng/mL)	Standard Deviation 1110
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	R-PZO	907 hoursnanogram per milliliter (hng/mL)	Standard Deviation 776.3

Secondary

Change From Baseline in Chemistry Parameter: C Reactive Protein

Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: C reactive protein. Change from baseline in chemistry parameter: C reactive protein at Day 1 were reported.

Time frame: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment.

Arm	Measure	Value (MEAN)	Dispersion
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameter: C Reactive Protein	0.411 milligram per liter (mg/L)	Standard Deviation 9.6546
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Chemistry Parameter: C Reactive Protein	0.004 milligram per liter (mg/L)	Standard Deviation 3.5448
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameter: C Reactive Protein	-0.336 milligram per liter (mg/L)	Standard Deviation 3.8792
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameter: C Reactive Protein	0.872 milligram per liter (mg/L)	Standard Deviation 4.6025
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameter: C Reactive Protein	-0.588 milligram per liter (mg/L)	Standard Deviation 4.2572
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Chemistry Parameter: C Reactive Protein	0.283 milligram per liter (mg/L)	Standard Deviation 3.3653

Secondary

Change From Baseline in Chemistry Parameters: Alanine Aminotransferase and Aspartate Aminotransferase

Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: Alanine Aminotransferase and Aspartate Aminotransferase. Change from baseline in chemistry parameters: Alanine Aminotransferase and Aspartate Aminotransferase at Day 1 were reported.

Time frame: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase and Aspartate Aminotransferase	Alanine Aminotransferase	-1.91 units per liter (U/L)	Standard Deviation 5.447
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase and Aspartate Aminotransferase	Aspartate Aminotransferase	-2.50 units per liter (U/L)	Standard Deviation 9.271
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase and Aspartate Aminotransferase	Alanine Aminotransferase	-1.23 units per liter (U/L)	Standard Deviation 6.245
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase and Aspartate Aminotransferase	Aspartate Aminotransferase	-0.59 units per liter (U/L)	Standard Deviation 12.759
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase and Aspartate Aminotransferase	Alanine Aminotransferase	-2.03 units per liter (U/L)	Standard Deviation 3.945
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase and Aspartate Aminotransferase	Aspartate Aminotransferase	-2.55 units per liter (U/L)	Standard Deviation 8.91
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase and Aspartate Aminotransferase	Alanine Aminotransferase	-0.40 units per liter (U/L)	Standard Deviation 5.959
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase and Aspartate Aminotransferase	Aspartate Aminotransferase	4.41 units per liter (U/L)	Standard Deviation 27.941
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase and Aspartate Aminotransferase	Alanine Aminotransferase	-1.27 units per liter (U/L)	Standard Deviation 2.532
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase and Aspartate Aminotransferase	Aspartate Aminotransferase	-2.87 units per liter (U/L)	Standard Deviation 4.805
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase and Aspartate Aminotransferase	Alanine Aminotransferase	-1.57 units per liter (U/L)	Standard Deviation 3.614
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Chemistry Parameters: Alanine Aminotransferase and Aspartate Aminotransferase	Aspartate Aminotransferase	-1.93 units per liter (U/L)	Standard Deviation 4.43

Secondary

Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin

Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: bilirubin, creatinine and direct bilirubin. Change from baseline in chemistry parameters: bilirubin, creatinine and direct bilirubin at Day 1 were reported.

Time frame: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment. Here Number Analyzed signifies those participants who were evaluated in specified categories.

Arm	Measure	Group	Value (MEAN)	Dispersion
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin	Direct Bilirubin	0.09 micromole per liter (mcmol/L)	Standard Deviation 0.937
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin	Bilirubin	-1.48 micromole per liter (mcmol/L)	Standard Deviation 3.056
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin	Creatinine	4.565 micromole per liter (mcmol/L)	Standard Deviation 10.7273
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin	Bilirubin	-0.22 micromole per liter (mcmol/L)	Standard Deviation 2.531
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin	Direct Bilirubin	0.06 micromole per liter (mcmol/L)	Standard Deviation 0.278
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin	Creatinine	6.386 micromole per liter (mcmol/L)	Standard Deviation 13.9391
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin	Creatinine	3.340 micromole per liter (mcmol/L)	Standard Deviation 16.7903
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin	Bilirubin	0.25 micromole per liter (mcmol/L)	Standard Deviation 3.651
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin	Direct Bilirubin	0.05 micromole per liter (mcmol/L)	Standard Deviation 0.219
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin	Direct Bilirubin	-0.04 micromole per liter (mcmol/L)	Standard Deviation 0.144
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin	Creatinine	1.644 micromole per liter (mcmol/L)	Standard Deviation 8.2799
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin	Bilirubin	-1.62 micromole per liter (mcmol/L)	Standard Deviation 3.075
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin	Creatinine	9.733 micromole per liter (mcmol/L)	Standard Deviation 10.722
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin	Direct Bilirubin	-0.05 micromole per liter (mcmol/L)	Standard Deviation 0.523
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin	Direct Bilirubin	0.07 micromole per liter (mcmol/L)	Standard Deviation 0.453
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin	Creatinine	6.967 micromole per liter (mcmol/L)	Standard Deviation 13.1561

Secondary

Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen

Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: glucose, urea and urea nitrogen. Change from baseline in chemistry parameters: glucose, urea and urea nitrogen at Day 1 were reported.

Time frame: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment. Here Number Analyzed signifies those participants who were evaluated in specified categories.

Arm	Measure	Group	Value (MEAN)	Dispersion
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen	Urea	0.061 millimole per liter (mmol/L)	Standard Deviation 0.1159
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen	Urea Nitrogen	1.443 millimole per liter (mmol/L)	Standard Deviation 1.2279
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen	Glucose	-0.056 millimole per liter (mmol/L)	Standard Deviation 1.2426
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen	Urea	0.087 millimole per liter (mmol/L)	Standard Deviation 0.0691
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen	Glucose	0.277 millimole per liter (mmol/L)	Standard Deviation 1.3265
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen	Urea Nitrogen	1.257 millimole per liter (mmol/L)	Standard Deviation 1.1638
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen	Urea	0.082 millimole per liter (mmol/L)	Standard Deviation 0.0611
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen	Glucose	0.207 millimole per liter (mmol/L)	Standard Deviation 1.2011
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen	Urea Nitrogen	2.017 millimole per liter (mmol/L)	Standard Deviation 1.7597
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen	Glucose	-0.354 millimole per liter (mmol/L)	Standard Deviation 1.4042
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen	Urea	0.043 millimole per liter (mmol/L)	Standard Deviation 0.0528
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen	Urea Nitrogen	0.614 millimole per liter (mmol/L)	Standard Deviation 0.9841
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen	Urea Nitrogen	1.966 millimole per liter (mmol/L)	Standard Deviation 1.2305
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen	Glucose	-0.070 millimole per liter (mmol/L)	Standard Deviation 1.0867
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen	Urea Nitrogen	2.432 millimole per liter (mmol/L)	Standard Deviation 1.3376
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen	Glucose	-0.052 millimole per liter (mmol/L)	Standard Deviation 1.4386

Secondary

Change From Baseline in Chemistry Parameter: Total Protein

Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: total Protein. Change from baseline in chemistry parameter: total Protein at Day 1 were reported.

Time frame: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment.

Arm	Measure	Value (MEAN)	Dispersion
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameter: Total Protein	-5.20 gram per liter (g/L)	Standard Deviation 5.001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Chemistry Parameter: Total Protein	-6.32 gram per liter (g/L)	Standard Deviation 5.018
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameter: Total Protein	-6.22 gram per liter (g/L)	Standard Deviation 7.241
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameter: Total Protein	0.16 gram per liter (g/L)	Standard Deviation 4.918
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Chemistry Parameter: Total Protein	-3.40 gram per liter (g/L)	Standard Deviation 5.308
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Chemistry Parameter: Total Protein	-3.18 gram per liter (g/L)	Standard Deviation 4.959

Secondary

Change From Baseline in Hematology Parameter: Erythrocytes

Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes. Change from baseline in hematology parameter: erythrocytes at Day 1 were reported.

Time frame: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment.

Arm	Measure	Value (MEAN)	Dispersion
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameter: Erythrocytes	-0.003 10^12 cells per liter	Standard Deviation 0.3245
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Hematology Parameter: Erythrocytes	-0.061 10^12 cells per liter	Standard Deviation 0.3792
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameter: Erythrocytes	-0.240 10^12 cells per liter	Standard Deviation 0.565
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameter: Erythrocytes	-0.044 10^12 cells per liter	Standard Deviation 0.3724
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameter: Erythrocytes	0.001 10^12 cells per liter	Standard Deviation 0.2921
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Hematology Parameter: Erythrocytes	-0.028 10^12 cells per liter	Standard Deviation 0.4

Secondary

Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin

Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Change from baseline in hematology parameter: erythrocytes mean corpuscular hemoglobin at Day 1 were reported.

Time frame: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment.

Arm	Measure	Value (MEAN)	Dispersion
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin	-0.12 picogram	Standard Deviation 1.273
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin	0.20 picogram	Standard Deviation 0.665
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin	0.18 picogram	Standard Deviation 0.348
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin	0.34 picogram	Standard Deviation 0.699
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin	0.02 picogram	Standard Deviation 0.325
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin	0.30 picogram	Standard Deviation 1.046

Secondary

Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume

Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes mean corpuscular volume. Change from baseline in hematology parameter: erythrocytes mean corpuscular volume at Day 1 were reported.

Time frame: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment.

Arm	Measure	Value (MEAN)	Dispersion
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume	-0.24 femtoliters	Standard Deviation 2.657
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume	-0.04 femtoliters	Standard Deviation 1.247
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume	-0.06 femtoliters	Standard Deviation 0.905
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume	0.16 femtoliters	Standard Deviation 2.101
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume	-0.88 femtoliters	Standard Deviation 0.948
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume	0.61 femtoliters	Standard Deviation 1.381

Secondary

Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration and Hemoglobin

Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: erythrocytes mean corpuscular HGB concentration and hemoglobin. Change from baseline in hematology parameters: erythrocytes mean corpuscular HGB concentration and hemoglobin at Day 1 were reported.

Time frame: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration and Hemoglobin	Erythrocytes Mean Corpuscular HGB Concentration	-0.6 gram per liter (g/L)	Standard Deviation 10.95
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration and Hemoglobin	Hemoglobin	-0.8 gram per liter (g/L)	Standard Deviation 8.26
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration and Hemoglobin	Erythrocytes Mean Corpuscular HGB Concentration	3.1 gram per liter (g/L)	Standard Deviation 9.97
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration and Hemoglobin	Hemoglobin	-0.0 gram per liter (g/L)	Standard Deviation 11.56
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration and Hemoglobin	Erythrocytes Mean Corpuscular HGB Concentration	5.2 gram per liter (g/L)	Standard Deviation 13.85
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration and Hemoglobin	Hemoglobin	-4.4 gram per liter (g/L)	Standard Deviation 10.29
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration and Hemoglobin	Erythrocytes Mean Corpuscular HGB Concentration	3.9 gram per liter (g/L)	Standard Deviation 11.25
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration and Hemoglobin	Hemoglobin	1.1 gram per liter (g/L)	Standard Deviation 7.22
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration and Hemoglobin	Erythrocytes Mean Corpuscular HGB Concentration	4.5 gram per liter (g/L)	Standard Deviation 6.52
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration and Hemoglobin	Hemoglobin	-0.1 gram per liter (g/L)	Standard Deviation 6.89
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration and Hemoglobin	Erythrocytes Mean Corpuscular HGB Concentration	1.0 gram per liter (g/L)	Standard Deviation 11.82
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration and Hemoglobin	Hemoglobin	0.8 gram per liter (g/L)	Standard Deviation 7.43

Secondary

Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes

Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: hematocrit, lymphocytes/leukocytes, mixed cells/leukocytes, neutrophils/leukocytes. Change from baseline in hematology parameters: hematocrit, lymphocytes/leukocytes, mixed cells/leukocytes, neutrophils/leukocytes at Day 1 were reported.

Time frame: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment. Here Number Analyzed signifies those participants who were evaluated in specified categories.

Arm	Measure	Group	Value (MEAN)	Dispersion
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Hematocrit	0.075 percentage of cells	Standard Deviation 3.3856
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Lymphocytes/Leukocytes	4.35 percentage of cells	Standard Deviation 10.617
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Mixed Cells/Leukocytes	-1.35 percentage of cells	Standard Deviation 6.526
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Neutrophils/Leukocytes	-2.01 percentage of cells	Standard Deviation 13.738
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Mixed Cells/Leukocytes	0.45 percentage of cells	Standard Deviation 7.579
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Lymphocytes/Leukocytes	1.69 percentage of cells	Standard Deviation 9.171
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Hematocrit	-0.434 percentage of cells	Standard Deviation 3.001
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Neutrophils/Leukocytes	-3.03 percentage of cells	Standard Deviation 13.733
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Neutrophils/Leukocytes	0.15 percentage of cells	Standard Deviation 13.43
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Mixed Cells/Leukocytes	0.07 percentage of cells	Standard Deviation 4.816
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Lymphocytes/Leukocytes	0.44 percentage of cells	Standard Deviation 10.39
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Hematocrit	-1.787 percentage of cells	Standard Deviation 3.9566
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Hematocrit	-0.144 percentage of cells	Standard Deviation 2.6203
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Neutrophils/Leukocytes	-6.32 percentage of cells	Standard Deviation 8.848
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Lymphocytes/Leukocytes	6.13 percentage of cells	Standard Deviation 7.579
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Mixed Cells/Leukocytes	0.19 percentage of cells	Standard Deviation 4.597
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Mixed Cells/Leukocytes	1.87 percentage of cells	Standard Deviation 4.278
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Neutrophils/Leukocytes	-11.68 percentage of cells	Standard Deviation 8.228
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Lymphocytes/Leukocytes	3.75 percentage of cells	Standard Deviation 7.973
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Hematocrit	-0.400 percentage of cells	Standard Deviation 2.3799
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Lymphocytes/Leukocytes	5.82 percentage of cells	Standard Deviation 8.456
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Mixed Cells/Leukocytes	-1.19 percentage of cells	Standard Deviation 6.436
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Neutrophils/Leukocytes	-4.60 percentage of cells	Standard Deviation 11.336
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes	Hematocrit	0.103 percentage of cells	Standard Deviation 3.0415

Secondary

Change From Baseline in Hematology Parameters: Leukocytes and Platelets

Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: leukocytes and platelets. Change from baseline in hematology parameters: leukocytes and platelets at Day 1 were reported.

Time frame: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Leukocytes and Platelets	Leukocytes	-0.357 10^9 cells per liter	Standard Deviation 2.25
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Leukocytes and Platelets	Platelets	-21.2 10^9 cells per liter	Standard Deviation 56.04
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Hematology Parameters: Leukocytes and Platelets	Leukocytes	-0.512 10^9 cells per liter	Standard Deviation 2.3055
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Hematology Parameters: Leukocytes and Platelets	Platelets	-24.5 10^9 cells per liter	Standard Deviation 39.08
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Leukocytes and Platelets	Leukocytes	-0.967 10^9 cells per liter	Standard Deviation 1.9043
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Leukocytes and Platelets	Platelets	-28.6 10^9 cells per liter	Standard Deviation 61.75
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Leukocytes and Platelets	Leukocytes	0.317 10^9 cells per liter	Standard Deviation 2.1385
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Leukocytes and Platelets	Platelets	49.7 10^9 cells per liter	Standard Deviation 170.67
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Leukocytes and Platelets	Leukocytes	-0.390 10^9 cells per liter	Standard Deviation 1.9805
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Hematology Parameters: Leukocytes and Platelets	Platelets	-10.0 10^9 cells per liter	Standard Deviation 33.12
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Hematology Parameters: Leukocytes and Platelets	Leukocytes	0.340 10^9 cells per liter	Standard Deviation 1.9324
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Hematology Parameters: Leukocytes and Platelets	Platelets	-14.0 10^9 cells per liter	Standard Deviation 62.78

Secondary

Change From Baseline in Urinalyses Parameter: Potential of Hydrogen (pH) of Urine

Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameter: pH. Change from baseline in urinalyses parameter: pH at Day 1 was reported.

Time frame: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment.

Arm	Measure	Value (MEAN)	Dispersion
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Urinalyses Parameter: Potential of Hydrogen (pH) of Urine	-0.33 pH	Standard Deviation 1.176
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Urinalyses Parameter: Potential of Hydrogen (pH) of Urine	-0.54 pH	Standard Deviation 1.068
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Urinalyses Parameter: Potential of Hydrogen (pH) of Urine	-0.50 pH	Standard Deviation 1.017
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Urinalyses Parameter: Potential of Hydrogen (pH) of Urine	-0.11 pH	Standard Deviation 0.654
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Urinalyses Parameter: Potential of Hydrogen (pH) of Urine	-0.42 pH	Standard Deviation 0.872
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Urinalyses Parameter: Potential of Hydrogen (pH) of Urine	-0.43 pH	Standard Deviation 0.899

Secondary

Change From Baseline in Urinalyses Parameter: Specific Gravity of Urine

Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameters: specific gravity. Change from baseline in urinalyses parameter: specific gravity Day 1 was reported.

Time frame: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment.

Arm	Measure	Value (MEAN)	Dispersion
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Urinalyses Parameter: Specific Gravity of Urine	0.0066 ratio	Standard Deviation 0.00797
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Urinalyses Parameter: Specific Gravity of Urine	0.0064 ratio	Standard Deviation 0.00722
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Urinalyses Parameter: Specific Gravity of Urine	0.0060 ratio	Standard Deviation 0.00781
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Urinalyses Parameter: Specific Gravity of Urine	0.0039 ratio	Standard Deviation 0.00932
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Urinalyses Parameter: Specific Gravity of Urine	0.0047 ratio	Standard Deviation 0.00787
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Urinalyses Parameter: Specific Gravity of Urine	0.0091 ratio	Standard Deviation 0.00704

Secondary

Change From Baseline in Urinalyses Parameter: Urobilinogen

Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameter: urobilinogen. Change from baseline in urinalyses parameter: urobilinogen at Day 1 were reported.

Time frame: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment.

Arm	Measure	Value (MEAN)	Dispersion
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Urinalyses Parameter: Urobilinogen	0.01 mcmol/L	Standard Deviation 4.069
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Urinalyses Parameter: Urobilinogen	0.19 mcmol/L	Standard Deviation 4.387
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Urinalyses Parameter: Urobilinogen	0.48 mcmol/L	Standard Deviation 2.355
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Urinalyses Parameter: Urobilinogen	0.00 mcmol/L	Standard Deviation 0
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Urinalyses Parameter: Urobilinogen	-0.03 mcmol/L	Standard Deviation 0.146
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Urinalyses Parameter: Urobilinogen	0.01 mcmol/L	Standard Deviation 0.09

Secondary

Change From Baseline in Vital Sign: Respiratory Rate

Respiratory rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital sign: respiratory rate at Week 3 was reported.

Time frame: Baseline, Week 3

Population: SAF included all participants who received 1 dose of study treatment.

Arm	Measure	Value (MEAN)	Dispersion
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Vital Sign: Respiratory Rate	0.5 breaths per minute	Standard Deviation 4.09
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Vital Sign: Respiratory Rate	-0.1 breaths per minute	Standard Deviation 3.63
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Vital Sign: Respiratory Rate	-1.0 breaths per minute	Standard Deviation 2.98
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Vital Sign: Respiratory Rate	-3.4 breaths per minute	Standard Deviation 8.91
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Vital Sign: Respiratory Rate	-2.6 breaths per minute	Standard Deviation 3.85
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Vital Sign: Respiratory Rate	-0.9 breaths per minute	Standard Deviation 4.02

Secondary

Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure

Diastolic blood pressure and systolic blood pressure were measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital signs: diastolic blood pressure and systolic blood pressure at Week 3 were reported.

Time frame: Baseline, Week 3

Population: SAF included all participants who received 1 dose of study treatment.

Arm	Measure	Group	Value (MEAN)	Dispersion
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure	Diastolic Blood Pressure	2.7 millimeters of mercury (mmHg)	Standard Deviation 10.92
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure	Systolic Blood Pressure	-0.5 millimeters of mercury (mmHg)	Standard Deviation 12.37
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure	Diastolic Blood Pressure	2.0 millimeters of mercury (mmHg)	Standard Deviation 9.49
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure	Systolic Blood Pressure	-1.4 millimeters of mercury (mmHg)	Standard Deviation 12.17
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure	Diastolic Blood Pressure	2.9 millimeters of mercury (mmHg)	Standard Deviation 10.58
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure	Systolic Blood Pressure	0.3 millimeters of mercury (mmHg)	Standard Deviation 12.58
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure	Diastolic Blood Pressure	-1.3 millimeters of mercury (mmHg)	Standard Deviation 10.27
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure	Systolic Blood Pressure	0.8 millimeters of mercury (mmHg)	Standard Deviation 8.06
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure	Diastolic Blood Pressure	1.2 millimeters of mercury (mmHg)	Standard Deviation 12.49
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure	Systolic Blood Pressure	-1.8 millimeters of mercury (mmHg)	Standard Deviation 9.78
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure	Diastolic Blood Pressure	4.1 millimeters of mercury (mmHg)	Standard Deviation 11.73
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure	Systolic Blood Pressure	3.7 millimeters of mercury (mmHg)	Standard Deviation 12.07

Secondary

Change From Baseline in Vital Signs: Pulse Rate

Pulse rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital sign: pulse rate at Week 3 was reported.

Time frame: Baseline, Week 3

Population: SAF included all participants who received 1 dose of study treatment.

Arm	Measure	Value (MEAN)	Dispersion
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Vital Signs: Pulse Rate	-1.8 beats per minute	Standard Deviation 14.65
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Vital Signs: Pulse Rate	-2.6 beats per minute	Standard Deviation 11.9
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Vital Signs: Pulse Rate	-4.1 beats per minute	Standard Deviation 20.46
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Vital Signs: Pulse Rate	-9.6 beats per minute	Standard Deviation 20.74
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Vital Signs: Pulse Rate	-3.7 beats per minute	Standard Deviation 18.78
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Vital Signs: Pulse Rate	-1.7 beats per minute	Standard Deviation 11.9

Secondary

Change From Baseline in Vital Signs: Temperature

Temperature was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital sign: temperature at Week 3 was reported.

Time frame: Baseline, Week 3

Population: SAF included all participants who received 1 dose of study treatment.

Arm	Measure	Value (MEAN)	Dispersion
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Vital Signs: Temperature	-0.02 degree Celsius	Standard Deviation 0.482
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Change From Baseline in Vital Signs: Temperature	-0.04 degree Celsius	Standard Deviation 0.529
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Vital Signs: Temperature	0.21 degree Celsius	Standard Deviation 0.734
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Change From Baseline in Vital Signs: Temperature	-0.10 degree Celsius	Standard Deviation 0.484
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Change From Baseline in Vital Signs: Temperature	-0.01 degree Celsius	Standard Deviation 0.529
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Change From Baseline in Vital Signs: Temperature	0.08 degree Celsius	Standard Deviation 0.427

Secondary

Cohort 1a, Cohort 1b, Cohort 2 and Cohort 3: Egg Reduction Rate (Percent [%]) Determined by Kato-Katz Method

Percentage of reduction in group mean egg count was calculated as relative difference between the post-treatment arithmetic mean egg count and pre-treatment arithmetic mean egg count at baseline count, (pre-treatment mean egg count minus post-treatment mean egg count divided by pre-treatment mean egg count) \*100. Egg counts were determined by the Kato-Katz method.

Time frame: Pre-treatment, Week 3 post-treatment

Population: mITT included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment.

Arm	Measure	Value (NUMBER)
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Cohort 1a, Cohort 1b, Cohort 2 and Cohort 3: Egg Reduction Rate (Percent [%]) Determined by Kato-Katz Method	99.5 percent reduction in egg count
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Cohort 1a, Cohort 1b, Cohort 2 and Cohort 3: Egg Reduction Rate (Percent [%]) Determined by Kato-Katz Method	99.2 percent reduction in egg count
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Cohort 1a, Cohort 1b, Cohort 2 and Cohort 3: Egg Reduction Rate (Percent [%]) Determined by Kato-Katz Method	88.5 percent reduction in egg count
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Cohort 1a, Cohort 1b, Cohort 2 and Cohort 3: Egg Reduction Rate (Percent [%]) Determined by Kato-Katz Method	95.6 percent reduction in egg count

Secondary

Cohort 1a, Cohort 1b, Cohort 2, and Cohort 3: Number of Participants With Clinical Cure Determined by Point-of-Care Circulating Cathodic Antigen (POC-CCA) Test

Clinical cure is defined as absence of test line in the POC-CCA test cassette (that is no Schistosoma antigens detected). Number of participants with clinical cure were reported.

Time frame: at Week 3

Population: mITT analysis population included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Cohort 1a, Cohort 1b, Cohort 2, and Cohort 3: Number of Participants With Clinical Cure Determined by Point-of-Care Circulating Cathodic Antigen (POC-CCA) Test	63 Participants
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Cohort 1a, Cohort 1b, Cohort 2, and Cohort 3: Number of Participants With Clinical Cure Determined by Point-of-Care Circulating Cathodic Antigen (POC-CCA) Test	26 Participants
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Cohort 1a, Cohort 1b, Cohort 2, and Cohort 3: Number of Participants With Clinical Cure Determined by Point-of-Care Circulating Cathodic Antigen (POC-CCA) Test	18 Participants
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Cohort 1a, Cohort 1b, Cohort 2, and Cohort 3: Number of Participants With Clinical Cure Determined by Point-of-Care Circulating Cathodic Antigen (POC-CCA) Test	13 Participants

Secondary

Cohort 1a, Cohort 1b, Cohort 4a and Cohort 4b: Palatability Assessment Based on Visual Analog Scale (VAS) Score

Palatability of the study intervention was assessed using a human gustatory sensation test (100-millimeter \[mm\] visual analog scale \[VAS\]) incorporating a facial hedonic scale, where lower score (0) indicates not acceptable/not liked at all and higher score (100) indicates very acceptable/liked very much.

Time frame: Day 1

Population: SAF included all participants who received 1 dose of study treatment. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

Arm	Measure	Value (MEDIAN)
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Cohort 1a, Cohort 1b, Cohort 4a and Cohort 4b: Palatability Assessment Based on Visual Analog Scale (VAS) Score	84.0 score on a scale
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Cohort 1a, Cohort 1b, Cohort 4a and Cohort 4b: Palatability Assessment Based on Visual Analog Scale (VAS) Score	50.0 score on a scale
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Cohort 1a, Cohort 1b, Cohort 4a and Cohort 4b: Palatability Assessment Based on Visual Analog Scale (VAS) Score	88.0 score on a scale
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Cohort 1a, Cohort 1b, Cohort 4a and Cohort 4b: Palatability Assessment Based on Visual Analog Scale (VAS) Score	88.0 score on a scale

Secondary

Cohort 2 and Cohort 3: Number of Participants With Clinical Cure Determined by Kato-Katz Method

Clinical cure was defined as no parasite egg in the stool at Week 3 as determined by the Kato-Katz method. Number of participants with clinical cure were reported.

Time frame: at Week 3

Population: mITT included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Cohort 2 and Cohort 3: Number of Participants With Clinical Cure Determined by Kato-Katz Method	27 Participants
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Cohort 2 and Cohort 3: Number of Participants With Clinical Cure Determined by Kato-Katz Method	17 Participants

Secondary

Cohort 4a and Cohort 4b: Egg Reduction Rate (Percent [%]) Determined by Urine Filtration Technique

Time frame: Pre-treatment, Weeks 3 and 5 post-treatment

Population: mITT included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment. Here Number Analyzed signifies those participants who were evaluated at the specified time point.

Arm	Measure	Group	Value (NUMBER)
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Cohort 4a and Cohort 4b: Egg Reduction Rate (Percent [%]) Determined by Urine Filtration Technique	Week 3	99.4 percent reduction in egg count
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Cohort 4a and Cohort 4b: Egg Reduction Rate (Percent [%]) Determined by Urine Filtration Technique	Week 3	99.2 percent reduction in egg count
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Cohort 4a and Cohort 4b: Egg Reduction Rate (Percent [%]) Determined by Urine Filtration Technique	Week 5	99.3 percent reduction in egg count

Secondary

Cohort 4a and Cohort 4b: Number of Participants With Clinical Cure Determined by Urine Filtration Technique

Clinical cure was defined as no parasite egg in the urine samples at follow up as determined by the urine filtration technique. Number of participants with clinical cure were reported.

Time frame: Week 3 and Week 5

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Cohort 4a and Cohort 4b: Number of Participants With Clinical Cure Determined by Urine Filtration Technique	Week 3	17 Participants
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Cohort 4a and Cohort 4b: Number of Participants With Clinical Cure Determined by Urine Filtration Technique	Week 3	50 Participants
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Cohort 4a and Cohort 4b: Number of Participants With Clinical Cure Determined by Urine Filtration Technique	Week 5	55 Participants

Secondary

Maximum Observed Plasma Concentration (Cmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ

Cmax was obtained directly from the plasma concentration versus time curve.

Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose

Population: The Pharmacokinetic Analysis Population (PKP) is a subset of the SAF population and consisted of all participants who received at least one dose of active Investigational Medicinal Product (IMP) and provide at least one measurable post-dose concentration.

Arm	Measure	Group	Value (MEAN)	Dispersion
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Maximum Observed Plasma Concentration (Cmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	R-PZO	347 nanogram per milliliter (ng/mL)	Standard Deviation 281.4
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Maximum Observed Plasma Concentration (Cmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	S-PZO	1.27 nanogram per milliliter (ng/mL)	Standard Deviation 2.834
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Maximum Observed Plasma Concentration (Cmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	R-PZO	59.3 nanogram per milliliter (ng/mL)	Standard Deviation 60.39
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Maximum Observed Plasma Concentration (Cmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	S-PZO	343 nanogram per milliliter (ng/mL)	Standard Deviation 298.9
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Maximum Observed Plasma Concentration (Cmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	R-PZO	1470 nanogram per milliliter (ng/mL)	Standard Deviation 1326
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Maximum Observed Plasma Concentration (Cmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	S-PZO	0.00 nanogram per milliliter (ng/mL)	Standard Deviation 0
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Maximum Observed Plasma Concentration (Cmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	R-PZO	NA nanogram per milliliter (ng/mL)	—
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Maximum Observed Plasma Concentration (Cmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	S-PZO	NA nanogram per milliliter (ng/mL)	—
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Maximum Observed Plasma Concentration (Cmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	R-PZO	523 nanogram per milliliter (ng/mL)	Standard Deviation 667.7
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Maximum Observed Plasma Concentration (Cmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	S-PZO	0.00 nanogram per milliliter (ng/mL)	Standard Deviation 0
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Maximum Observed Plasma Concentration (Cmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	R-PZO	300 nanogram per milliliter (ng/mL)	Standard Deviation 239.7
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Maximum Observed Plasma Concentration (Cmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	S-PZO	0.360 nanogram per milliliter (ng/mL)	Standard Deviation 1.394

Secondary

Number of Participants With Reaction to Study Intervention Administration

Reaction to study intervention administration were recorded to describe tolerability as assessed by nurse/site staff for all children enrolled in the study. Reactions categorized as spitting, crying, diarrheas, sleepiness, abdominal pain, fever, vomiting and other. Number of participants with reaction to study intervention administration reported.

Time frame: Day 1

Population: SAF anlysis population included all participants who received 1 dose of study treatment.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Diarrhoea	16 Participants
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Spitting	1 Participants
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Crying	1 Participants
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Sleepiness	7 Participants
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Abdominal pain	21 Participants
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Fever	1 Participants
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Vomiting	7 Participants
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Other	3 Participants
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Sleepiness	3 Participants
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Other	1 Participants
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Crying	4 Participants
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Vomiting	4 Participants
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Fever	1 Participants
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Diarrhoea	3 Participants
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Spitting	3 Participants
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Abdominal pain	9 Participants
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Spitting	6 Participants
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Diarrhoea	4 Participants
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Sleepiness	7 Participants
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Other	0 Participants
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Abdominal pain	9 Participants
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Fever	0 Participants
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Vomiting	4 Participants
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Crying	8 Participants
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Vomiting	1 Participants
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Fever	0 Participants
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Abdominal pain	0 Participants
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Crying	8 Participants
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Diarrhoea	2 Participants
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Sleepiness	2 Participants
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Other	0 Participants
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Spitting	6 Participants
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Other	0 Participants
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Crying	2 Participants
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Abdominal pain	0 Participants
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Fever	0 Participants
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Vomiting	0 Participants
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Spitting	0 Participants
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Diarrhoea	0 Participants
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Sleepiness	0 Participants
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Other	1 Participants
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Abdominal pain	2 Participants
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Diarrhoea	2 Participants
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Sleepiness	1 Participants
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Fever	0 Participants
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Spitting	3 Participants
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Vomiting	0 Participants
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Number of Participants With Reaction to Study Intervention Administration	Crying	2 Participants

Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale

Severity of TEAEs were graded using Qualitative Toxicity Scale, as follows: Mild: Participant is aware of the event or symptom, but the event or symptom is easily tolerated; Moderate: Participant experiences sufficient discomfort to interfere with or reduce his or her usual level of activity; Severe: Significant impairment of functioning: the participant is unable to carry out his or her usual activities. Number of participants with TEAEs by severity were reported.

Time frame: up to Day 40

Population: SAF anlysis population included all participants who received 1 dose of study treatment.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale	Moderate	21 Participants
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale	Mild	57 Participants
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale	Severe	1 Participants
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale	Moderate	8 Participants
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale	Mild	27 Participants
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale	Severe	1 Participants
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale	Moderate	9 Participants
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale	Mild	19 Participants
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale	Severe	1 Participants
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale	Moderate	2 Participants
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale	Mild	14 Participants
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale	Severe	0 Participants
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale	Moderate	4 Participants
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale	Mild	5 Participants
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale	Severe	0 Participants
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale	Mild	21 Participants
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale	Severe	1 Participants
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale	Moderate	12 Participants

Secondary

Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs

Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs were defined as those events with onset dates/time occurring after study intervention administration or events that worsen after study intervention administration. TEAEs included serious TEAEs and non-serious TEAEs. Treatment-related TEAEs: reasonably related to the study intervention.

Time frame: up to Day 40

Population: SAF anlysis population included all participants who received 1 dose of study treatment.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs	Participants with serious TEAEs	0 Participants
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs	Participants with TEAEs	66 Participants
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs	Participants with treatment-related TEAEs	31 Participants
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs	Participants with serious TEAEs	0 Participants
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs	Participants with TEAEs	31 Participants
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs	Participants with treatment-related TEAEs	14 Participants
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs	Participants with serious TEAEs	0 Participants
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs	Participants with TEAEs	20 Participants
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs	Participants with treatment-related TEAEs	16 Participants
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs	Participants with serious TEAEs	0 Participants
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs	Participants with TEAEs	14 Participants
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs	Participants with treatment-related TEAEs	4 Participants
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs	Participants with serious TEAEs	0 Participants
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs	Participants with TEAEs	9 Participants
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs	Participants with treatment-related TEAEs	0 Participants
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs	Participants with TEAEs	28 Participants
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs	Participants with treatment-related TEAEs	5 Participants
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs	Participants with serious TEAEs	1 Participants

Secondary

Time to Reach Maximum Plasma Concentration (Tmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ

Tmax was obtained directly from the plasma concentration versus time curve.

Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose

Arm	Measure	Group	Value (MEDIAN)
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Time to Reach Maximum Plasma Concentration (Tmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	R-PZO	02.00 hours
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg	Time to Reach Maximum Plasma Concentration (Tmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	S-PZO	0.00 hours
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Time to Reach Maximum Plasma Concentration (Tmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	R-PZO	01.00 hours
Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg	Time to Reach Maximum Plasma Concentration (Tmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	S-PZO	2.49 hours
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Time to Reach Maximum Plasma Concentration (Tmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	R-PZO	03.00 hours
Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg	Time to Reach Maximum Plasma Concentration (Tmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	S-PZO	0.00 hours
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Time to Reach Maximum Plasma Concentration (Tmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	R-PZO	NA hours
Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg	Time to Reach Maximum Plasma Concentration (Tmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	S-PZO	NA hours
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Time to Reach Maximum Plasma Concentration (Tmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	R-PZO	1.50 hours
Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg	Time to Reach Maximum Plasma Concentration (Tmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	S-PZO	0.00 hours
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Time to Reach Maximum Plasma Concentration (Tmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	R-PZO	03.00 hours
Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg	Time to Reach Maximum Plasma Concentration (Tmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ	S-PZO	0.00 hours

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026

L-PZQ ODT in Schistosoma Infected Children

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Cohort 1a and Cohort 1b: Number of Participants With Clinical Cure Determined by Kato-Katz Method

Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ

Change From Baseline in Chemistry Parameter: C Reactive Protein

Change From Baseline in Chemistry Parameters: Alanine Aminotransferase and Aspartate Aminotransferase

Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin

Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen

Change From Baseline in Chemistry Parameter: Total Protein

Change From Baseline in Hematology Parameter: Erythrocytes

Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin

Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume

Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration and Hemoglobin

Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes

Change From Baseline in Hematology Parameters: Leukocytes and Platelets

Change From Baseline in Urinalyses Parameter: Potential of Hydrogen (pH) of Urine

Change From Baseline in Urinalyses Parameter: Specific Gravity of Urine

Change From Baseline in Urinalyses Parameter: Urobilinogen

Change From Baseline in Vital Sign: Respiratory Rate

Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure

Change From Baseline in Vital Signs: Pulse Rate

Change From Baseline in Vital Signs: Temperature

Cohort 1a, Cohort 1b, Cohort 2 and Cohort 3: Egg Reduction Rate (Percent [%]) Determined by Kato-Katz Method

Cohort 1a, Cohort 1b, Cohort 2, and Cohort 3: Number of Participants With Clinical Cure Determined by Point-of-Care Circulating Cathodic Antigen (POC-CCA) Test

Cohort 1a, Cohort 1b, Cohort 4a and Cohort 4b: Palatability Assessment Based on Visual Analog Scale (VAS) Score

Cohort 2 and Cohort 3: Number of Participants With Clinical Cure Determined by Kato-Katz Method

Cohort 4a and Cohort 4b: Egg Reduction Rate (Percent [%]) Determined by Urine Filtration Technique

Cohort 4a and Cohort 4b: Number of Participants With Clinical Cure Determined by Urine Filtration Technique

Maximum Observed Plasma Concentration (Cmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ

Number of Participants With Reaction to Study Intervention Administration

Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale

Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs

Time to Reach Maximum Plasma Concentration (Tmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ