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Study to Assess the Safety, Tolerability and PK/PD After 4 Weekly SC Injections of PB1046 in Subjects With Stable HFrEF

Randomized, Double-blind, Placebo-controlled, Multiple-Dose, Study to Assess the Safety, Tolerability, PK and PD After 4 Weeks of Once Weekly Sc. Inj. of PB1046 in Adults With Stable HFrEF, and in Subjects With Cardiac Dysfunction Secondary to DMD

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02808585
Enrollment
29
Registered
2016-06-22
Start date
2016-06-30
Completion date
2017-12-06
Last updated
2022-07-14

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

Conditions

Heart Failure

Brief summary

This study will be a sequential multiple-dose escalation study that will enroll (randomize and dose) approximately 28 subjects in four cohorts consisting of 3 active and 1 placebo in Cohort 1 and 6 active and 2 placebo in subsequent cohorts. Randomized subjects will receive a fixed weekly dose of study drug or placebo for a 4 week dosing period.

Detailed description

Qualifying subjects will have a diagnosis of NYHA Class II or III heart failure with a reduced ejection fraction (HFrEF), be in stable condition, and be taking clinician-directed appropriate pharmacological therapy (e.g., angiotensin converting enzyme inhibitors, angiotensin receptor blockers or an evidence based beta blocker) for heart failure at stable doses (with the exception of diuretics) for at least 1 month prior to screening. During the period between screening and randomization (planned first dose), the study subject will remain on stable pharmacological therapy for heart failure. Also the study subject will be in stable health with no hospitalizations or clinically significant acute illnesses between screening and randomization that would put the subject at increased risk for study participation. Randomized subjects will receive a fixed weekly dose of study drug or placebo for a 4 week dosing period. Dose escalation in subsequent cohorts will continue if the safety and pharmacokinetic profile are deemed acceptable as assessed by the Study Review Committee.

Interventions

DRUGPB1046 Injection

Four weekly subcutaneous injections of PB1046.

DRUGPlacebo Injection

Four weekly subcutaneous injections of placebo.

Sponsors

PhaseBio Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Willing and able to sign a written informed consent and follow all study-related procedures, * Male subjects and female subjects of reproductive or childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study drug, * Body mass index ≥ 18 kg/m2 and ≤ 45 kg/m2, * Receipt of stable pharmacological therapy(ies) for heart failure for a minimum of 1 month prior to screening and between screening and randomization and are in stable clinical condition, * NYHA Class II or III heart failure diagnosis (ischemic or non-ischemic confirmed by medical history) at least 6 months prior to screening, * Stable HF defined as no hospitalizations for cardiac related issues within the previous 3 months prior to the screening visit or between screening and randomization, * A screening or historical Left Ventricular Ejection Fraction ≤ 40% by centralized reading of 2-D echocardiography, * Screening hemoglobin ≥ 9.0 g/dL secondary to the volume of blood to be collected during the study period, * Willing and able to return to the study unit for specified study visits, and be able to self-monitor blood pressure while at home, * Live and work in an area with reliable cellular services (e.g., Sprint®) for real time transmission of telemetry data to the core laboratory.

Exclusion criteria

* Have previously received PB1046 or have a known allergy to the study drug or any of its components, * Participating in any other study and have received any other investigational medication or device within 30 days prior to screening or are taking part in a non-medication study which, in the opinion of the Investigator, would interfere with study compliance or outcome assessments, * Diagnosed with acute coronary syndrome (ACS) or an acute myocardial infarction (MI) within 3 months of screening, * Canadian Cardiovascular Society (CCS) Class III or IV angina necessitating frequent use of as needed short acting nitroglycerin, * Cardiac surgery or valvuloplasty within 3 months prior to screening, * Cerebrovascular accident or transient ischemic attack within 3 months prior to screening, * Sustained systolic blood pressure (SBP) \< 110 mmHg and/or diastolic blood pressure (DBP) \< 50 mmHg (confirmed by a duplicate seated reading) on at least 3 consecutive readings (self-monitored or office) prior to randomization or overt symptomatic hypotension, * Sustained resting heart rate \>100 beats per minute (BPM) at screening (V1) or prior to randomization, * History or evidence of clinically significant arrhythmias (uncontrolled by drug therapy or use of an implantable defibrillator), long QT syndrome or evidence of QT prolongation demonstrating QTcF \> 460 ms prior to randomization (Subjects with QTcF \>460 ms due to electronic pacing by an implanted pacemaker/ICD device may be enrolled), * Clinically significant renal dysfunction as measured by the estimated glomerular filtration rate (eGFR) of \< 40 mL/min/1.73m2 as calculated by the CKD-EPI creatinine-cystatin C equation at screening, or a clinically significant change in renal function between screening and baseline, * Clinically significant liver dysfunction as measured by: alanine aminotransferase \>3.0 × the upper limit of normal (ULN), aspartate aminotransferase \>3.0 × the ULN, or serum bilirubin ≥ 1.6 mg/dL at screening, or a clinically significant change in liver function between screening and baseline, * Pregnant or lactating female subjects, * Known history of or active alcohol abuse or use of illicit drugs within 1 year prior to randomization, * Positive screening for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies, * Any major surgical procedure within 1 month prior to screening or planned surgical procedure during the study period, * Other medical or psychiatric condition which, in the opinion of the Investigator, would place the subject at increased risk or would preclude obtaining voluntary consent/assent or would confound the secondary objectives of study.

Design outcomes

Primary

MeasureTime frameDescription
Vital Signs - Diastolic Blood PressureBaseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.Changes from baseline in vital signs (systolic blood pressure) and the relationship to PB1046 compared to placebo.
Laboratory Parameters - Hematology - Participants With Clinically Significant FindingsEight weeks starting one week before first dose.Number of participants with clinically significant changes from baseline in laboratory parameters (hematology) and the relationship to PB1046 compared to placebo
Laboratory Parameters - Urinalysis - Participants With Clinically Significant FindingsEight weeks starting one week before first dose.Number of participants with clinically significant changes from baseline in laboratory parameters (urinalysis) and the relationship to PB1046 compared to placebo
Laboratory Parameters - eGFRBaseline, Week 2, 3, 4, 5 and 8.Changes from baseline in laboratory parameters (eGFR) and the relationship to PB1046 compared to placebo. Calculated using Chronic Kidney Disease Epidemiology Collaboration Equation (CKD-EPI)
Laboratory Parameters - Lipid Profile - Participants With Clinically Significant FindingsEight weeks starting one week before first dose (Baseline and at Week 8).Number of participants with clinically significant changes from baseline in laboratory parameters (lipid profile) and the relationship to PB1046 compared to placebo
Vital Signs - Systolic Blood PressureBaseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.Changes from baseline in vital signs (systolic blood pressure) and the relationship to PB1046 compared to placebo.
Vital Signs - Heart RateBaseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.Changes from baseline in vital signs (heart rate) and the relationship to PB1046 compared to placebo.
Vital Signs - TemperatureBaseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.Changes from baseline in vital signs (temperature) and the relationship to PB1046 compared to placebo.
Vital Signs - Respiratory RateBaseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.Changes from baseline in vital signs (respiratory rate) and the relationship to PB1046 compared to placebo.
TelemetryUp to six weeks starting 7 to 10 days before first dose.Number of participants with rhythm abnormalities as assessed by continuous mobile telemetry monitoring.
12-Lead ECG Assessment - Incidence of Clinically Significant FindingsSeven weeks starting the first week of dosing.Number of participants with a clinically significant change from baseline in 12-Lead ECG and presence of rhythm abnormalities and relationship to exposure of PB1046 compared to placebo
12-Lead ECG - Categorical Analysis of QT/QTc Interval - Participants With Clinically Significant FindingsSeven weeks starting the first week of dosing.Number of participants with a clinically significant change from baseline in 12-Lead ECG and presence or absence of rhythm abnormalities and relationship to exposure of PB1046 compared to placebo
Laboratory Parameters - Serum Chemistry - Participants With Clinically Significant FindingsEight weeks starting one week before first dose.Number of participants with clinically significant changes from baseline in laboratory parameters (serum chemistry) and the relationship to PB1046 compared to placebo

Secondary

MeasureTime frameDescription
Pharmacokinetic Profile - Maximum Serum Concentration (Cmax)Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.Comparison of dose exposures (Cmax) during once weekly administration of various doses of PB1046
Pharmacokinetic Profile - Time to Cmax (Tmax)Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.Comparison of dose exposures (Tmax) during once weekly administration of various doses of PB1046
Pharmacokinetic Profile - Elimination Rate Constant (Lambda z)Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.Comparison of dose exposures (lambda z) during once weekly administration of various doses of PB1046
Pharmacokinetic Profile - Elimination Half-life (t½)Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.Comparison of dose exposures (t½) during once weekly administration of various doses of PB1046
Pharmacokinetic Profile - Clearance (CL/F), Uncorrected for BioavailabilityPre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.Comparison of dose exposures (CL/F) during once weekly administration of various doses of PB1046
Pharmacokinetic Profile - Volume of Distribution (Vz/F), Uncorrected for Bioavailability (F)Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.Comparison of dose exposures (Vz/F) during once weekly administration of various doses of PB1046
ImmunogenicityEleven weeks starting the first week of dosing.Number of participants reporting positive immunogenicity (four-fold increase of pre-dose titer)
Pharmacokinetic Profile - Area Under the Curve Over the Dosing Interval [AUC(0-t)]Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.Comparison of dose exposures \[AUC(0-t)\] during once weekly administration of various doses of PB1046

Countries

United States

Participant flow

Participants by arm

ArmCount
PB1046 Injection, 0.2 mg/kg
Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046.
3
PB1046 Injection, 0.4 mg/kg
Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046.
6
PB1046 Injection, 0.6 mg/kg
Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046.
7
PB1046 Injection, 1.2 mg/kg
Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046.
6
Placebo Comparator
Four weekly doses of Placebo (0.9% NaCl) Injection Placebo Injection: Four weekly subcutaneous injections of placebo.
7
Total29

Baseline characteristics

CharacteristicTotalPlacebo ComparatorPB1046 Injection, 1.2 mg/kgPB1046 Injection, 0.6 mg/kgPB1046 Injection, 0.4 mg/kgPB1046 Injection, 0.2 mg/kg
Age, Continuous66.0 years
STANDARD_DEVIATION 9.18
65 years
STANDARD_DEVIATION 8.41
64.3 years
STANDARD_DEVIATION 4.03
67.6 years
STANDARD_DEVIATION 11.27
69.7 years
STANDARD_DEVIATION 10.89
60.7 years
STANDARD_DEVIATION 13.01
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants0 Participants0 Participants1 Participants0 Participants
Race (NIH/OMB)
Black or African American
3 Participants1 Participants0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
25 Participants6 Participants6 Participants6 Participants5 Participants2 Participants
Region of Enrollment
United States
29 participants7 participants6 participants7 participants6 participants3 participants
Sex: Female, Male
Female
8 Participants1 Participants2 Participants3 Participants0 Participants2 Participants
Sex: Female, Male
Male
21 Participants6 Participants4 Participants4 Participants6 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
0 / 30 / 60 / 70 / 60 / 7
other
Total, other adverse events
3 / 36 / 67 / 76 / 60 / 7
serious
Total, serious adverse events
0 / 31 / 60 / 70 / 60 / 7

Outcome results

Primary

12-Lead ECG Assessment - Incidence of Clinically Significant Findings

Number of participants with a clinically significant change from baseline in 12-Lead ECG and presence of rhythm abnormalities and relationship to exposure of PB1046 compared to placebo

Time frame: Seven weeks starting the first week of dosing.

Population: Safety/Intent-to-Treat/Per Protocol Population

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PB1046 Injection, 0.2 mg/kg12-Lead ECG Assessment - Incidence of Clinically Significant Findings0 Participants
PB1046 Injection, 0.4 mg/kg12-Lead ECG Assessment - Incidence of Clinically Significant Findings0 Participants
PB1046 Injection, 0.6 mg/kg12-Lead ECG Assessment - Incidence of Clinically Significant Findings0 Participants
PB1046 Injection, 1.2 mg/kg12-Lead ECG Assessment - Incidence of Clinically Significant Findings0 Participants
Placebo Comparator12-Lead ECG Assessment - Incidence of Clinically Significant Findings0 Participants
Primary

12-Lead ECG - Categorical Analysis of QT/QTc Interval - Participants With Clinically Significant Findings

Number of participants with a clinically significant change from baseline in 12-Lead ECG and presence or absence of rhythm abnormalities and relationship to exposure of PB1046 compared to placebo

Time frame: Seven weeks starting the first week of dosing.

Population: Safety/Intent-to-Treat/Per Protocol Population

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PB1046 Injection, 0.2 mg/kg12-Lead ECG - Categorical Analysis of QT/QTc Interval - Participants With Clinically Significant Findings0 Participants
PB1046 Injection, 0.4 mg/kg12-Lead ECG - Categorical Analysis of QT/QTc Interval - Participants With Clinically Significant Findings0 Participants
PB1046 Injection, 0.6 mg/kg12-Lead ECG - Categorical Analysis of QT/QTc Interval - Participants With Clinically Significant Findings0 Participants
PB1046 Injection, 1.2 mg/kg12-Lead ECG - Categorical Analysis of QT/QTc Interval - Participants With Clinically Significant Findings0 Participants
Placebo Comparator12-Lead ECG - Categorical Analysis of QT/QTc Interval - Participants With Clinically Significant Findings0 Participants
Primary

Laboratory Parameters - eGFR

Changes from baseline in laboratory parameters (eGFR) and the relationship to PB1046 compared to placebo. Calculated using Chronic Kidney Disease Epidemiology Collaboration Equation (CKD-EPI)

Time frame: Baseline, Week 2, 3, 4, 5 and 8.

Population: Safety/Intent-to-Treat/Per Protocol Population. One subject at 0.6 mg/kg dose missed sample collection and was excluded from analysis.

ArmMeasureGroupValue (MEAN)Dispersion
PB1046 Injection, 0.2 mg/kgLaboratory Parameters - eGFRWeek 5-0.3 mL/min/1.73m^2Standard Deviation 6.66
PB1046 Injection, 0.2 mg/kgLaboratory Parameters - eGFRWeek 2-1.04 mL/min/1.73m^2Standard Deviation 4
PB1046 Injection, 0.2 mg/kgLaboratory Parameters - eGFRWeek 8-3.3 mL/min/1.73m^2Standard Deviation 8.62
PB1046 Injection, 0.2 mg/kgLaboratory Parameters - eGFRWeek 3-0.3 mL/min/1.73m^2Standard Deviation 5.77
PB1046 Injection, 0.2 mg/kgLaboratory Parameters - eGFRWeek 40.0 mL/min/1.73m^2Standard Deviation 2.65
PB1046 Injection, 0.4 mg/kgLaboratory Parameters - eGFRWeek 5-0.7 mL/min/1.73m^2Standard Deviation 7.26
PB1046 Injection, 0.4 mg/kgLaboratory Parameters - eGFRWeek 4-1.3 mL/min/1.73m^2Standard Deviation 7.97
PB1046 Injection, 0.4 mg/kgLaboratory Parameters - eGFRWeek 30.2 mL/min/1.73m^2Standard Deviation 10.72
PB1046 Injection, 0.4 mg/kgLaboratory Parameters - eGFRWeek 8-5.7 mL/min/1.73m^2Standard Deviation 11.41
PB1046 Injection, 0.4 mg/kgLaboratory Parameters - eGFRWeek 22.2 mL/min/1.73m^2Standard Deviation 11.41
PB1046 Injection, 0.6 mg/kgLaboratory Parameters - eGFRWeek 4-1.4 mL/min/1.73m^2Standard Deviation 4.12
PB1046 Injection, 0.6 mg/kgLaboratory Parameters - eGFRWeek 2-2.9 mL/min/1.73m^2Standard Deviation 13.23
PB1046 Injection, 0.6 mg/kgLaboratory Parameters - eGFRWeek 32.3 mL/min/1.73m^2Standard Deviation 11.4
PB1046 Injection, 0.6 mg/kgLaboratory Parameters - eGFRWeek 5-2.2 mL/min/1.73m^2Standard Deviation 13.29
PB1046 Injection, 0.6 mg/kgLaboratory Parameters - eGFRWeek 8-3.7 mL/min/1.73m^2Standard Deviation 14.22
PB1046 Injection, 1.2 mg/kgLaboratory Parameters - eGFRWeek 8-0.2 mL/min/1.73m^2Standard Deviation 6.79
PB1046 Injection, 1.2 mg/kgLaboratory Parameters - eGFRWeek 21.3 mL/min/1.73m^2Standard Deviation 7.39
PB1046 Injection, 1.2 mg/kgLaboratory Parameters - eGFRWeek 59.3 mL/min/1.73m^2Standard Deviation 7.93
PB1046 Injection, 1.2 mg/kgLaboratory Parameters - eGFRWeek 45.8 mL/min/1.73m^2Standard Deviation 9.55
PB1046 Injection, 1.2 mg/kgLaboratory Parameters - eGFRWeek 31.8 mL/min/1.73m^2Standard Deviation 7.57
Placebo ComparatorLaboratory Parameters - eGFRWeek 4-6.6 mL/min/1.73m^2Standard Deviation 6.13
Placebo ComparatorLaboratory Parameters - eGFRWeek 5-2.3 mL/min/1.73m^2Standard Deviation 6.63
Placebo ComparatorLaboratory Parameters - eGFRWeek 2-4.6 mL/min/1.73m^2Standard Deviation 5.88
Placebo ComparatorLaboratory Parameters - eGFRWeek 8-3.0 mL/min/1.73m^2Standard Deviation 4.12
Placebo ComparatorLaboratory Parameters - eGFRWeek 3-4.6 mL/min/1.73m^2Standard Deviation 5.19
Primary

Laboratory Parameters - Hematology - Participants With Clinically Significant Findings

Number of participants with clinically significant changes from baseline in laboratory parameters (hematology) and the relationship to PB1046 compared to placebo

Time frame: Eight weeks starting one week before first dose.

Population: Safety/Intent-to-Treat/Per Protocol Population

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PB1046 Injection, 0.2 mg/kgLaboratory Parameters - Hematology - Participants With Clinically Significant Findings1 Participants
PB1046 Injection, 0.4 mg/kgLaboratory Parameters - Hematology - Participants With Clinically Significant Findings0 Participants
PB1046 Injection, 0.6 mg/kgLaboratory Parameters - Hematology - Participants With Clinically Significant Findings0 Participants
PB1046 Injection, 1.2 mg/kgLaboratory Parameters - Hematology - Participants With Clinically Significant Findings0 Participants
Placebo ComparatorLaboratory Parameters - Hematology - Participants With Clinically Significant Findings0 Participants
Primary

Laboratory Parameters - Lipid Profile - Participants With Clinically Significant Findings

Number of participants with clinically significant changes from baseline in laboratory parameters (lipid profile) and the relationship to PB1046 compared to placebo

Time frame: Eight weeks starting one week before first dose (Baseline and at Week 8).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PB1046 Injection, 0.2 mg/kgLaboratory Parameters - Lipid Profile - Participants With Clinically Significant Findings0 Participants
PB1046 Injection, 0.4 mg/kgLaboratory Parameters - Lipid Profile - Participants With Clinically Significant Findings0 Participants
PB1046 Injection, 0.6 mg/kgLaboratory Parameters - Lipid Profile - Participants With Clinically Significant Findings0 Participants
PB1046 Injection, 1.2 mg/kgLaboratory Parameters - Lipid Profile - Participants With Clinically Significant Findings0 Participants
Placebo ComparatorLaboratory Parameters - Lipid Profile - Participants With Clinically Significant Findings0 Participants
Primary

Laboratory Parameters - Serum Chemistry - Participants With Clinically Significant Findings

Number of participants with clinically significant changes from baseline in laboratory parameters (serum chemistry) and the relationship to PB1046 compared to placebo

Time frame: Eight weeks starting one week before first dose.

Population: Safety/Intent-to-Treat/Per Protocol Population

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PB1046 Injection, 0.2 mg/kgLaboratory Parameters - Serum Chemistry - Participants With Clinically Significant Findings0 Participants
PB1046 Injection, 0.4 mg/kgLaboratory Parameters - Serum Chemistry - Participants With Clinically Significant Findings1 Participants
PB1046 Injection, 0.6 mg/kgLaboratory Parameters - Serum Chemistry - Participants With Clinically Significant Findings0 Participants
PB1046 Injection, 1.2 mg/kgLaboratory Parameters - Serum Chemistry - Participants With Clinically Significant Findings0 Participants
Placebo ComparatorLaboratory Parameters - Serum Chemistry - Participants With Clinically Significant Findings0 Participants
Primary

Laboratory Parameters - Urinalysis - Participants With Clinically Significant Findings

Number of participants with clinically significant changes from baseline in laboratory parameters (urinalysis) and the relationship to PB1046 compared to placebo

Time frame: Eight weeks starting one week before first dose.

Population: Safety/Intent-to-Treat/Per Protocol Population

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PB1046 Injection, 0.2 mg/kgLaboratory Parameters - Urinalysis - Participants With Clinically Significant Findings0 Participants
PB1046 Injection, 0.4 mg/kgLaboratory Parameters - Urinalysis - Participants With Clinically Significant Findings2 Participants
PB1046 Injection, 0.6 mg/kgLaboratory Parameters - Urinalysis - Participants With Clinically Significant Findings0 Participants
PB1046 Injection, 1.2 mg/kgLaboratory Parameters - Urinalysis - Participants With Clinically Significant Findings0 Participants
Placebo ComparatorLaboratory Parameters - Urinalysis - Participants With Clinically Significant Findings0 Participants
Primary

Telemetry

Number of participants with rhythm abnormalities as assessed by continuous mobile telemetry monitoring.

Time frame: Up to six weeks starting 7 to 10 days before first dose.

Population: Safety/Intent-to-Treat/Per Protocol Population

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PB1046 Injection, 0.2 mg/kgTelemetry0 Participants
PB1046 Injection, 0.4 mg/kgTelemetry0 Participants
PB1046 Injection, 0.6 mg/kgTelemetry0 Participants
PB1046 Injection, 1.2 mg/kgTelemetry0 Participants
Placebo ComparatorTelemetry0 Participants
Primary

Vital Signs - Diastolic Blood Pressure

Changes from baseline in vital signs (systolic blood pressure) and the relationship to PB1046 compared to placebo.

Time frame: Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.

Population: Safety/Intent-to-Treat/Per Protocol Population

ArmMeasureGroupValue (MEAN)Dispersion
PB1046 Injection, 0.2 mg/kgVital Signs - Diastolic Blood PressureDay 21 pre0.7 mmHgStandard Deviation 2.4
PB1046 Injection, 0.2 mg/kgVital Signs - Diastolic Blood PressureDay 31-4.3 mmHgStandard Deviation 4.04
PB1046 Injection, 0.2 mg/kgVital Signs - Diastolic Blood PressureDay 23-2.1 mmHgStandard Deviation 5
PB1046 Injection, 0.2 mg/kgVital Signs - Diastolic Blood PressureDay 21 1 hr-3.4 mmHgStandard Deviation 1.26
PB1046 Injection, 0.2 mg/kgVital Signs - Diastolic Blood PressureDay 1-2.7 mmHgStandard Deviation 1.76
PB1046 Injection, 0.2 mg/kgVital Signs - Diastolic Blood PressureDay 22-2.1 mmHgStandard Deviation 4.4
PB1046 Injection, 0.2 mg/kgVital Signs - Diastolic Blood PressureDay 21 3 hr-1.4 mmHgStandard Deviation 3.91
PB1046 Injection, 0.2 mg/kgVital Signs - Diastolic Blood PressureDay 0 1 hr-2.3 mmHgStandard Deviation 3.38
PB1046 Injection, 0.2 mg/kgVital Signs - Diastolic Blood PressureDay 2-0.9 mmHgStandard Deviation 5.09
PB1046 Injection, 0.2 mg/kgVital Signs - Diastolic Blood PressureDay 492.6 mmHgStandard Deviation 2.22
PB1046 Injection, 0.2 mg/kgVital Signs - Diastolic Blood PressureDay 302.8 mmHgStandard Deviation 2.52
PB1046 Injection, 0.2 mg/kgVital Signs - Diastolic Blood PressureDay 3-5.8 mmHgStandard Deviation 2.17
PB1046 Injection, 0.2 mg/kgVital Signs - Diastolic Blood PressureDay 0 3 hr-0.1 mmHgStandard Deviation 2.5
PB1046 Injection, 0.2 mg/kgVital Signs - Diastolic Blood PressureDay 291.6 mmHgStandard Deviation 7.34
PB1046 Injection, 0.2 mg/kgVital Signs - Diastolic Blood PressureDay 51.1 mmHgStandard Deviation 7.88
PB1046 Injection, 0.2 mg/kgVital Signs - Diastolic Blood PressureDay 28-1.4 mmHgStandard Deviation 1.58
PB1046 Injection, 0.2 mg/kgVital Signs - Diastolic Blood PressureDay 7 pre-2.2 mmHgStandard Deviation 8.6
PB1046 Injection, 0.2 mg/kgVital Signs - Diastolic Blood PressureDay 26-1.4 mmHgStandard Deviation 7.13
PB1046 Injection, 0.2 mg/kgVital Signs - Diastolic Blood PressureDay 14 pre3.1 mmHgStandard Deviation 4.44
PB1046 Injection, 0.2 mg/kgVital Signs - Diastolic Blood PressureDay 241.0 mmHgStandard Deviation 2.91
PB1046 Injection, 0.4 mg/kgVital Signs - Diastolic Blood PressureDay 7 pre-2.5 mmHgStandard Deviation 6.88
PB1046 Injection, 0.4 mg/kgVital Signs - Diastolic Blood PressureDay 21 pre-1.3 mmHgStandard Deviation 8.5
PB1046 Injection, 0.4 mg/kgVital Signs - Diastolic Blood PressureDay 30.1 mmHgStandard Deviation 10.36
PB1046 Injection, 0.4 mg/kgVital Signs - Diastolic Blood PressureDay 0 1 hr-5.7 mmHgStandard Deviation 13.53
PB1046 Injection, 0.4 mg/kgVital Signs - Diastolic Blood PressureDay 22-6.1 mmHgStandard Deviation 10.52
PB1046 Injection, 0.4 mg/kgVital Signs - Diastolic Blood PressureDay 31-4.6 mmHgStandard Deviation 10.98
PB1046 Injection, 0.4 mg/kgVital Signs - Diastolic Blood PressureDay 21 1 hr-4.9 mmHgStandard Deviation 11.98
PB1046 Injection, 0.4 mg/kgVital Signs - Diastolic Blood PressureDay 28-1.4 mmHgStandard Deviation 9.43
PB1046 Injection, 0.4 mg/kgVital Signs - Diastolic Blood PressureDay 241.3 mmHgStandard Deviation 7.61
PB1046 Injection, 0.4 mg/kgVital Signs - Diastolic Blood PressureDay 21 3 hr-7.3 mmHgStandard Deviation 6.34
PB1046 Injection, 0.4 mg/kgVital Signs - Diastolic Blood PressureDay 51.3 mmHgStandard Deviation 9.01
PB1046 Injection, 0.4 mg/kgVital Signs - Diastolic Blood PressureDay 1-1.9 mmHgStandard Deviation 9.52
PB1046 Injection, 0.4 mg/kgVital Signs - Diastolic Blood PressureDay 49-3.1 mmHgStandard Deviation 7.86
PB1046 Injection, 0.4 mg/kgVital Signs - Diastolic Blood PressureDay 0 3 hr-3.1 mmHgStandard Deviation 11.89
PB1046 Injection, 0.4 mg/kgVital Signs - Diastolic Blood PressureDay 30-2.8 mmHgStandard Deviation 7.92
PB1046 Injection, 0.4 mg/kgVital Signs - Diastolic Blood PressureDay 23-2.1 mmHgStandard Deviation 8.88
PB1046 Injection, 0.4 mg/kgVital Signs - Diastolic Blood PressureDay 2-1.7 mmHgStandard Deviation 7.48
PB1046 Injection, 0.4 mg/kgVital Signs - Diastolic Blood PressureDay 26-6.1 mmHgStandard Deviation 9.86
PB1046 Injection, 0.4 mg/kgVital Signs - Diastolic Blood PressureDay 14 pre-2.9 mmHgStandard Deviation 7.07
PB1046 Injection, 0.4 mg/kgVital Signs - Diastolic Blood PressureDay 29-2.0 mmHgStandard Deviation 6.72
PB1046 Injection, 0.6 mg/kgVital Signs - Diastolic Blood PressureDay 30-1.9 mmHgStandard Deviation 11.77
PB1046 Injection, 0.6 mg/kgVital Signs - Diastolic Blood PressureDay 0 1 hr-2.5 mmHgStandard Deviation 10.64
PB1046 Injection, 0.6 mg/kgVital Signs - Diastolic Blood PressureDay 0 3 hr-4.4 mmHgStandard Deviation 11.1
PB1046 Injection, 0.6 mg/kgVital Signs - Diastolic Blood PressureDay 1-1.5 mmHgStandard Deviation 7.77
PB1046 Injection, 0.6 mg/kgVital Signs - Diastolic Blood PressureDay 2-3.0 mmHgStandard Deviation 9.41
PB1046 Injection, 0.6 mg/kgVital Signs - Diastolic Blood PressureDay 3-2.0 mmHgStandard Deviation 8.14
PB1046 Injection, 0.6 mg/kgVital Signs - Diastolic Blood PressureDay 5-1.1 mmHgStandard Deviation 6.61
PB1046 Injection, 0.6 mg/kgVital Signs - Diastolic Blood PressureDay 7 pre-1.4 mmHgStandard Deviation 12.28
PB1046 Injection, 0.6 mg/kgVital Signs - Diastolic Blood PressureDay 14 pre-0.2 mmHgStandard Deviation 7.73
PB1046 Injection, 0.6 mg/kgVital Signs - Diastolic Blood PressureDay 21 pre2.1 mmHgStandard Deviation 10.83
PB1046 Injection, 0.6 mg/kgVital Signs - Diastolic Blood PressureDay 21 1 hr-2.2 mmHgStandard Deviation 9.7
PB1046 Injection, 0.6 mg/kgVital Signs - Diastolic Blood PressureDay 21 3 hr-0.9 mmHgStandard Deviation 10.82
PB1046 Injection, 0.6 mg/kgVital Signs - Diastolic Blood PressureDay 22-2.2 mmHgStandard Deviation 9.8
PB1046 Injection, 0.6 mg/kgVital Signs - Diastolic Blood PressureDay 23-3.2 mmHgStandard Deviation 12.1
PB1046 Injection, 0.6 mg/kgVital Signs - Diastolic Blood PressureDay 241.7 mmHgStandard Deviation 9.05
PB1046 Injection, 0.6 mg/kgVital Signs - Diastolic Blood PressureDay 26-3.2 mmHgStandard Deviation 10.03
PB1046 Injection, 0.6 mg/kgVital Signs - Diastolic Blood PressureDay 28-0.2 mmHgStandard Deviation 8.64
PB1046 Injection, 0.6 mg/kgVital Signs - Diastolic Blood PressureDay 29-1.5 mmHgStandard Deviation 9.98
PB1046 Injection, 0.6 mg/kgVital Signs - Diastolic Blood PressureDay 310.3 mmHgStandard Deviation 10.02
PB1046 Injection, 0.6 mg/kgVital Signs - Diastolic Blood PressureDay 49-5.3 mmHgStandard Deviation 11.08
PB1046 Injection, 1.2 mg/kgVital Signs - Diastolic Blood PressureDay 21 pre-5.8 mmHgStandard Deviation 5.91
PB1046 Injection, 1.2 mg/kgVital Signs - Diastolic Blood PressureDay 31-8.9 mmHgStandard Deviation 6.1
PB1046 Injection, 1.2 mg/kgVital Signs - Diastolic Blood PressureDay 23-6.1 mmHgStandard Deviation 5.39
PB1046 Injection, 1.2 mg/kgVital Signs - Diastolic Blood PressureDay 14 pre-4.7 mmHgStandard Deviation 7.88
PB1046 Injection, 1.2 mg/kgVital Signs - Diastolic Blood PressureDay 24-12.8 mmHgStandard Deviation 14.55
PB1046 Injection, 1.2 mg/kgVital Signs - Diastolic Blood PressureDay 7 pre-2.5 mmHgStandard Deviation 15.6
PB1046 Injection, 1.2 mg/kgVital Signs - Diastolic Blood PressureDay 26-6.4 mmHgStandard Deviation 6.58
PB1046 Injection, 1.2 mg/kgVital Signs - Diastolic Blood PressureDay 5-6.9 mmHgStandard Deviation 12.32
PB1046 Injection, 1.2 mg/kgVital Signs - Diastolic Blood PressureDay 0 1 hr-1.4 mmHgStandard Deviation 5.68
PB1046 Injection, 1.2 mg/kgVital Signs - Diastolic Blood PressureDay 28-8.3 mmHgStandard Deviation 12.66
PB1046 Injection, 1.2 mg/kgVital Signs - Diastolic Blood PressureDay 3-11.3 mmHgStandard Deviation 7.33
PB1046 Injection, 1.2 mg/kgVital Signs - Diastolic Blood PressureDay 29-3.7 mmHgStandard Deviation 9.64
PB1046 Injection, 1.2 mg/kgVital Signs - Diastolic Blood PressureDay 2-5.7 mmHgStandard Deviation 7.2
PB1046 Injection, 1.2 mg/kgVital Signs - Diastolic Blood PressureDay 1-9.5 mmHgStandard Deviation 11.69
PB1046 Injection, 1.2 mg/kgVital Signs - Diastolic Blood PressureDay 30-8.8 mmHgStandard Deviation 5.47
PB1046 Injection, 1.2 mg/kgVital Signs - Diastolic Blood PressureDay 0 3 hr-3.9 mmHgStandard Deviation 4.08
PB1046 Injection, 1.2 mg/kgVital Signs - Diastolic Blood PressureDay 21 3 hr-9.8 mmHgStandard Deviation 8.03
PB1046 Injection, 1.2 mg/kgVital Signs - Diastolic Blood PressureDay 21 1 hr-9.8 mmHgStandard Deviation 6.43
PB1046 Injection, 1.2 mg/kgVital Signs - Diastolic Blood PressureDay 49-5.0 mmHgStandard Deviation 10.27
PB1046 Injection, 1.2 mg/kgVital Signs - Diastolic Blood PressureDay 22-10.8 mmHgStandard Deviation 8.63
Placebo ComparatorVital Signs - Diastolic Blood PressureDay 0 3 hr2.6 mmHgStandard Deviation 3.5
Placebo ComparatorVital Signs - Diastolic Blood PressureDay 14 pre6.0 mmHgStandard Deviation 6.28
Placebo ComparatorVital Signs - Diastolic Blood PressureDay 23.6 mmHgStandard Deviation 10.18
Placebo ComparatorVital Signs - Diastolic Blood PressureDay 495.1 mmHgStandard Deviation 4.89
Placebo ComparatorVital Signs - Diastolic Blood PressureDay 234.5 mmHgStandard Deviation 7.81
Placebo ComparatorVital Signs - Diastolic Blood PressureDay 21 1 hr2.2 mmHgStandard Deviation 8.35
Placebo ComparatorVital Signs - Diastolic Blood PressureDay 7 pre3.6 mmHgStandard Deviation 6.05
Placebo ComparatorVital Signs - Diastolic Blood PressureDay 313.9 mmHgStandard Deviation 6.99
Placebo ComparatorVital Signs - Diastolic Blood PressureDay 292.9 mmHgStandard Deviation 6.22
Placebo ComparatorVital Signs - Diastolic Blood PressureDay 243.0 mmHgStandard Deviation 10.5
Placebo ComparatorVital Signs - Diastolic Blood PressureDay 221.8 mmHgStandard Deviation 9.89
Placebo ComparatorVital Signs - Diastolic Blood PressureDay 51.2 mmHgStandard Deviation 5.82
Placebo ComparatorVital Signs - Diastolic Blood PressureDay 0 1 hr7.8 mmHgStandard Deviation 9.34
Placebo ComparatorVital Signs - Diastolic Blood PressureDay 13.8 mmHgStandard Deviation 7.99
Placebo ComparatorVital Signs - Diastolic Blood PressureDay 260.8 mmHgStandard Deviation 6.74
Placebo ComparatorVital Signs - Diastolic Blood PressureDay 21 pre4.2 mmHgStandard Deviation 7.23
Placebo ComparatorVital Signs - Diastolic Blood PressureDay 32.8 mmHgStandard Deviation 7.93
Placebo ComparatorVital Signs - Diastolic Blood PressureDay 21 3 hr4.3 mmHgStandard Deviation 6.82
Placebo ComparatorVital Signs - Diastolic Blood PressureDay 303.6 mmHgStandard Deviation 9.02
Placebo ComparatorVital Signs - Diastolic Blood PressureDay 283.7 mmHgStandard Deviation 10.41
Primary

Vital Signs - Heart Rate

Changes from baseline in vital signs (heart rate) and the relationship to PB1046 compared to placebo.

Time frame: Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.

Population: Safety/Intent-to-Treat/Per Protocol Population

ArmMeasureGroupValue (MEAN)Dispersion
PB1046 Injection, 0.2 mg/kgVital Signs - Heart RateDay 49-2.0 Beats/minStandard Deviation 2.33
PB1046 Injection, 0.2 mg/kgVital Signs - Heart RateDay 23-1.8 Beats/minStandard Deviation 1.68
PB1046 Injection, 0.2 mg/kgVital Signs - Heart RateDay 290.3 Beats/minStandard Deviation 3.18
PB1046 Injection, 0.2 mg/kgVital Signs - Heart RateDay 0 3 hr2.7 Beats/minStandard Deviation 6.49
PB1046 Injection, 0.2 mg/kgVital Signs - Heart RateDay 30-2.4 Beats/minStandard Deviation 2.5
PB1046 Injection, 0.2 mg/kgVital Signs - Heart RateDay 21 1 hr3.6 Beats/minStandard Deviation 4.67
PB1046 Injection, 0.2 mg/kgVital Signs - Heart RateDay 222.2 Beats/minStandard Deviation 3.02
PB1046 Injection, 0.2 mg/kgVital Signs - Heart RateDay 28-2.0 Beats/minStandard Deviation 8.09
PB1046 Injection, 0.2 mg/kgVital Signs - Heart RateDay 1-0.7 Beats/minStandard Deviation 1.15
PB1046 Injection, 0.2 mg/kgVital Signs - Heart RateDay 14 pre-2.4 Beats/minStandard Deviation 2.14
PB1046 Injection, 0.2 mg/kgVital Signs - Heart RateDay 7 pre0.6 Beats/minStandard Deviation 2.67
PB1046 Injection, 0.2 mg/kgVital Signs - Heart RateDay 5-1.2 Beats/minStandard Deviation 3.67
PB1046 Injection, 0.2 mg/kgVital Signs - Heart RateDay 261.4 Beats/minStandard Deviation 3.91
PB1046 Injection, 0.2 mg/kgVital Signs - Heart RateDay 21.7 Beats/minStandard Deviation 2.31
PB1046 Injection, 0.2 mg/kgVital Signs - Heart RateDay 0 1 hr-1.8 Beats/minStandard Deviation 4.55
PB1046 Injection, 0.2 mg/kgVital Signs - Heart RateDay 31-3.4 Beats/minStandard Deviation 3.1
PB1046 Injection, 0.2 mg/kgVital Signs - Heart RateDay 21 3 hr8.3 Beats/minStandard Deviation 4.93
PB1046 Injection, 0.2 mg/kgVital Signs - Heart RateDay 24-2.4 Beats/minStandard Deviation 3.15
PB1046 Injection, 0.2 mg/kgVital Signs - Heart RateDay 33.8 Beats/minStandard Deviation 1.35
PB1046 Injection, 0.2 mg/kgVital Signs - Heart RateDay 21 pre3.6 Beats/minStandard Deviation 4.67
PB1046 Injection, 0.4 mg/kgVital Signs - Heart RateDay 3-0.8 Beats/minStandard Deviation 5.51
PB1046 Injection, 0.4 mg/kgVital Signs - Heart RateDay 23-2.4 Beats/minStandard Deviation 13.1
PB1046 Injection, 0.4 mg/kgVital Signs - Heart RateDay 5-2.9 Beats/minStandard Deviation 5.06
PB1046 Injection, 0.4 mg/kgVital Signs - Heart RateDay 21 pre-2.6 Beats/minStandard Deviation 7.62
PB1046 Injection, 0.4 mg/kgVital Signs - Heart RateDay 22-3.3 Beats/minStandard Deviation 10.02
PB1046 Injection, 0.4 mg/kgVital Signs - Heart RateDay 21 3 hr3.6 Beats/minStandard Deviation 3.62
PB1046 Injection, 0.4 mg/kgVital Signs - Heart RateDay 30-3.9 Beats/minStandard Deviation 11.54
PB1046 Injection, 0.4 mg/kgVital Signs - Heart RateDay 21 1 hr-1.4 Beats/minStandard Deviation 7.49
PB1046 Injection, 0.4 mg/kgVital Signs - Heart RateDay 7 pre-0.4 Beats/minStandard Deviation 5.74
PB1046 Injection, 0.4 mg/kgVital Signs - Heart RateDay 0 1 hr-2.1 Beats/minStandard Deviation 6.23
PB1046 Injection, 0.4 mg/kgVital Signs - Heart RateDay 14 pre-3.7 Beats/minStandard Deviation 6.26
PB1046 Injection, 0.4 mg/kgVital Signs - Heart RateDay 29-2.5 Beats/minStandard Deviation 8.62
PB1046 Injection, 0.4 mg/kgVital Signs - Heart RateDay 0 3 hr-2.4 Beats/minStandard Deviation 5.39
PB1046 Injection, 0.4 mg/kgVital Signs - Heart RateDay 49-2.9 Beats/minStandard Deviation 14.19
PB1046 Injection, 0.4 mg/kgVital Signs - Heart RateDay 28-0.5 Beats/minStandard Deviation 11.09
PB1046 Injection, 0.4 mg/kgVital Signs - Heart RateDay 14.1 Beats/minStandard Deviation 3.38
PB1046 Injection, 0.4 mg/kgVital Signs - Heart RateDay 31-4.9 Beats/minStandard Deviation 8.27
PB1046 Injection, 0.4 mg/kgVital Signs - Heart RateDay 26-2.2 Beats/minStandard Deviation 10.56
PB1046 Injection, 0.4 mg/kgVital Signs - Heart RateDay 2-6.0 Beats/minStandard Deviation 15.58
PB1046 Injection, 0.4 mg/kgVital Signs - Heart RateDay 24-0.8 Beats/minStandard Deviation 8.52
PB1046 Injection, 0.6 mg/kgVital Signs - Heart RateDay 30-3.6 Beats/minStandard Deviation 7.61
PB1046 Injection, 0.6 mg/kgVital Signs - Heart RateDay 14 pre-0.6 Beats/minStandard Deviation 2.65
PB1046 Injection, 0.6 mg/kgVital Signs - Heart RateDay 21 pre-2.7 Beats/minStandard Deviation 2.72
PB1046 Injection, 0.6 mg/kgVital Signs - Heart RateDay 21 1 hr0.9 Beats/minStandard Deviation 2.23
PB1046 Injection, 0.6 mg/kgVital Signs - Heart RateDay 0 1 hr-2.5 Beats/minStandard Deviation 9.66
PB1046 Injection, 0.6 mg/kgVital Signs - Heart RateDay 0 3 hr0.0 Beats/minStandard Deviation 8.67
PB1046 Injection, 0.6 mg/kgVital Signs - Heart RateDay 1-1.6 Beats/minStandard Deviation 9.66
PB1046 Injection, 0.6 mg/kgVital Signs - Heart RateDay 2-3.3 Beats/minStandard Deviation 8.73
PB1046 Injection, 0.6 mg/kgVital Signs - Heart RateDay 3-2.2 Beats/minStandard Deviation 4.24
PB1046 Injection, 0.6 mg/kgVital Signs - Heart RateDay 5-3.2 Beats/minStandard Deviation 9.09
PB1046 Injection, 0.6 mg/kgVital Signs - Heart RateDay 21 3 hr-0.9 Beats/minStandard Deviation 3.51
PB1046 Injection, 0.6 mg/kgVital Signs - Heart RateDay 220.3 Beats/minStandard Deviation 5.37
PB1046 Injection, 0.6 mg/kgVital Signs - Heart RateDay 23-2.5 Beats/minStandard Deviation 5.92
PB1046 Injection, 0.6 mg/kgVital Signs - Heart RateDay 24-2.1 Beats/minStandard Deviation 4.65
PB1046 Injection, 0.6 mg/kgVital Signs - Heart RateDay 26-1.6 Beats/minStandard Deviation 6.97
PB1046 Injection, 0.6 mg/kgVital Signs - Heart RateDay 28-1.5 Beats/minStandard Deviation 2.1
PB1046 Injection, 0.6 mg/kgVital Signs - Heart RateDay 29-2.1 Beats/minStandard Deviation 9.99
PB1046 Injection, 0.6 mg/kgVital Signs - Heart RateDay 7 pre-4.5 Beats/minStandard Deviation 6.05
PB1046 Injection, 0.6 mg/kgVital Signs - Heart RateDay 31-1.4 Beats/minStandard Deviation 4.96
PB1046 Injection, 0.6 mg/kgVital Signs - Heart RateDay 49-2.3 Beats/minStandard Deviation 4.67
PB1046 Injection, 1.2 mg/kgVital Signs - Heart RateDay 31.4 Beats/minStandard Deviation 5.86
PB1046 Injection, 1.2 mg/kgVital Signs - Heart RateDay 0 1 hr2.3 Beats/minStandard Deviation 3.64
PB1046 Injection, 1.2 mg/kgVital Signs - Heart RateDay 7 pre1.6 Beats/minStandard Deviation 1.83
PB1046 Injection, 1.2 mg/kgVital Signs - Heart RateDay 292.9 Beats/minStandard Deviation 7.47
PB1046 Injection, 1.2 mg/kgVital Signs - Heart RateDay 14.1 Beats/minStandard Deviation 5.53
PB1046 Injection, 1.2 mg/kgVital Signs - Heart RateDay 491.8 Beats/minStandard Deviation 4.84
PB1046 Injection, 1.2 mg/kgVital Signs - Heart RateDay 21 pre0.2 Beats/minStandard Deviation 0.96
PB1046 Injection, 1.2 mg/kgVital Signs - Heart RateDay 260.4 Beats/minStandard Deviation 1.13
PB1046 Injection, 1.2 mg/kgVital Signs - Heart RateDay 300.8 Beats/minStandard Deviation 1.67
PB1046 Injection, 1.2 mg/kgVital Signs - Heart RateDay 22.6 Beats/minStandard Deviation 3.83
PB1046 Injection, 1.2 mg/kgVital Signs - Heart RateDay 31-1.6 Beats/minStandard Deviation 1.95
PB1046 Injection, 1.2 mg/kgVital Signs - Heart RateDay 21 1 hr1.2 Beats/minStandard Deviation 1
PB1046 Injection, 1.2 mg/kgVital Signs - Heart RateDay 0 3 hr1.2 Beats/minStandard Deviation 2.83
PB1046 Injection, 1.2 mg/kgVital Signs - Heart RateDay 21 3 hr0.9 Beats/minStandard Deviation 1.83
PB1046 Injection, 1.2 mg/kgVital Signs - Heart RateDay 241.4 Beats/minStandard Deviation 1.4
PB1046 Injection, 1.2 mg/kgVital Signs - Heart RateDay 280.2 Beats/minStandard Deviation 1.97
PB1046 Injection, 1.2 mg/kgVital Signs - Heart RateDay 52.9 Beats/minStandard Deviation 5.85
PB1046 Injection, 1.2 mg/kgVital Signs - Heart RateDay 14 pre0.5 Beats/minStandard Deviation 1.29
PB1046 Injection, 1.2 mg/kgVital Signs - Heart RateDay 220.4 Beats/minStandard Deviation 1.07
PB1046 Injection, 1.2 mg/kgVital Signs - Heart RateDay 231.4 Beats/minStandard Deviation 1.32
Placebo ComparatorVital Signs - Heart RateDay 220.3 Beats/minStandard Deviation 8.1
Placebo ComparatorVital Signs - Heart RateDay 23-0.9 Beats/minStandard Deviation 10.13
Placebo ComparatorVital Signs - Heart RateDay 24.5 Beats/minStandard Deviation 8.66
Placebo ComparatorVital Signs - Heart RateDay 24-1.5 Beats/minStandard Deviation 7.49
Placebo ComparatorVital Signs - Heart RateDay 13.2 Beats/minStandard Deviation 4.09
Placebo ComparatorVital Signs - Heart RateDay 310.5 Beats/minStandard Deviation 7.43
Placebo ComparatorVital Signs - Heart RateDay 26-0.8 Beats/minStandard Deviation 7.77
Placebo ComparatorVital Signs - Heart RateDay 0 3 hr3.0 Beats/minStandard Deviation 9.64
Placebo ComparatorVital Signs - Heart RateDay 7 pre-1.7 Beats/minStandard Deviation 8.01
Placebo ComparatorVital Signs - Heart RateDay 28-2.8 Beats/minStandard Deviation 7.52
Placebo ComparatorVital Signs - Heart RateDay 0 1 hr-3.0 Beats/minStandard Deviation 5.79
Placebo ComparatorVital Signs - Heart RateDay 29-1.1 Beats/minStandard Deviation 6.84
Placebo ComparatorVital Signs - Heart RateDay 21 pre-4.7 Beats/minStandard Deviation 5.84
Placebo ComparatorVital Signs - Heart RateDay 49-2.4 Beats/minStandard Deviation 5.7
Placebo ComparatorVital Signs - Heart RateDay 301.7 Beats/minStandard Deviation 8.13
Placebo ComparatorVital Signs - Heart RateDay 21 1 hr-4.7 Beats/minStandard Deviation 5.84
Placebo ComparatorVital Signs - Heart RateDay 14 pre-1.9 Beats/minStandard Deviation 7.16
Placebo ComparatorVital Signs - Heart RateDay 21 3 hr0.2 Beats/minStandard Deviation 10.92
Placebo ComparatorVital Signs - Heart RateDay 53.1 Beats/minStandard Deviation 8.62
Placebo ComparatorVital Signs - Heart RateDay 3-.04 Beats/minStandard Deviation 6.82
Primary

Vital Signs - Respiratory Rate

Changes from baseline in vital signs (respiratory rate) and the relationship to PB1046 compared to placebo.

Time frame: Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.

Population: Safety/Intent-to-Treat/Per Protocol Population

ArmMeasureGroupValue (MEAN)Dispersion
PB1046 Injection, 0.2 mg/kgVital Signs - Respiratory RateDay 0 1 hr0.7 Breaths/minStandard Deviation 1.15
PB1046 Injection, 0.2 mg/kgVital Signs - Respiratory RateDay 21 3 hr0.0 Breaths/minStandard Deviation 2
PB1046 Injection, 0.2 mg/kgVital Signs - Respiratory RateDay 230.0 Breaths/minStandard Deviation 2
PB1046 Injection, 0.2 mg/kgVital Signs - Respiratory RateDay 21 pre-1.3 Breaths/minStandard Deviation 1.15
PB1046 Injection, 0.2 mg/kgVital Signs - Respiratory RateDay 300.7 Breaths/minStandard Deviation 1.15
PB1046 Injection, 0.2 mg/kgVital Signs - Respiratory RateDay 220.0 Breaths/minStandard Deviation 2
PB1046 Injection, 0.2 mg/kgVital Signs - Respiratory RateDay 10.7 Breaths/minStandard Deviation 1.15
PB1046 Injection, 0.2 mg/kgVital Signs - Respiratory RateDay 29-0.7 Breaths/minStandard Deviation 1.15
PB1046 Injection, 0.2 mg/kgVital Signs - Respiratory RateDay 21.0 Breaths/minStandard Deviation 1
PB1046 Injection, 0.2 mg/kgVital Signs - Respiratory RateDay 49-0.7 Breaths/minStandard Deviation 1.15
PB1046 Injection, 0.2 mg/kgVital Signs - Respiratory RateDay 280.0 Breaths/minStandard Deviation 2
PB1046 Injection, 0.2 mg/kgVital Signs - Respiratory RateDay 30.7 Breaths/minStandard Deviation 1.15
PB1046 Injection, 0.2 mg/kgVital Signs - Respiratory RateDay 0 3hr1.3 Breaths/minStandard Deviation 2.31
PB1046 Injection, 0.2 mg/kgVital Signs - Respiratory RateDay 26-0.7 Breaths/minStandard Deviation 1.15
PB1046 Injection, 0.2 mg/kgVital Signs - Respiratory RateDay 50.0 Breaths/minStandard Deviation 0
PB1046 Injection, 0.2 mg/kgVital Signs - Respiratory RateDay 24-0.7 Breaths/minStandard Deviation 1.15
PB1046 Injection, 0.2 mg/kgVital Signs - Respiratory RateDay 21 1hr-1.3 Breaths/minStandard Deviation 1.15
PB1046 Injection, 0.4 mg/kgVital Signs - Respiratory RateDay 50.4 Breaths/minStandard Deviation 1.75
PB1046 Injection, 0.4 mg/kgVital Signs - Respiratory RateDay 281.2 Breaths/minStandard Deviation 3.37
PB1046 Injection, 0.4 mg/kgVital Signs - Respiratory RateDay 21 3 hr0.0 Breaths/minStandard Deviation 0
PB1046 Injection, 0.4 mg/kgVital Signs - Respiratory RateDay 301.3 Breaths/minStandard Deviation 2.42
PB1046 Injection, 0.4 mg/kgVital Signs - Respiratory RateDay 0 3hr0.7 Breaths/minStandard Deviation 2.07
PB1046 Injection, 0.4 mg/kgVital Signs - Respiratory RateDay 221.5 Breaths/minStandard Deviation 2.51
PB1046 Injection, 0.4 mg/kgVital Signs - Respiratory RateDay 241.2 Breaths/minStandard Deviation 2.56
PB1046 Injection, 0.4 mg/kgVital Signs - Respiratory RateDay 21 pre1.0 Breaths/minStandard Deviation 3.52
PB1046 Injection, 0.4 mg/kgVital Signs - Respiratory RateDay 3-1.2 Breaths/minStandard Deviation 2.15
PB1046 Injection, 0.4 mg/kgVital Signs - Respiratory RateDay 0 1 hr0.3 Breaths/minStandard Deviation 1.51
PB1046 Injection, 0.4 mg/kgVital Signs - Respiratory RateDay 261.2 Breaths/minStandard Deviation 2.56
PB1046 Injection, 0.4 mg/kgVital Signs - Respiratory RateDay 10.3 Breaths/minStandard Deviation 2.25
PB1046 Injection, 0.4 mg/kgVital Signs - Respiratory RateDay 491.2 Breaths/minStandard Deviation 2.4
PB1046 Injection, 0.4 mg/kgVital Signs - Respiratory RateDay 291.7 Breaths/minStandard Deviation 3.44
PB1046 Injection, 0.4 mg/kgVital Signs - Respiratory RateDay 230.8 Breaths/minStandard Deviation 1.6
PB1046 Injection, 0.4 mg/kgVital Signs - Respiratory RateDay 21 1hr0.7 Breaths/minStandard Deviation 2.07
PB1046 Injection, 0.4 mg/kgVital Signs - Respiratory RateDay 20.3 Breaths/minStandard Deviation 1.77
PB1046 Injection, 0.6 mg/kgVital Signs - Respiratory RateDay 23-1.0 Breaths/minStandard Deviation 2.1
PB1046 Injection, 0.6 mg/kgVital Signs - Respiratory RateDay 0 1 hr0.9 Breaths/minStandard Deviation 1.57
PB1046 Injection, 0.6 mg/kgVital Signs - Respiratory RateDay 0 3hr0.0 Breaths/minStandard Deviation 1.15
PB1046 Injection, 0.6 mg/kgVital Signs - Respiratory RateDay 1-0.6 Breaths/minStandard Deviation 1.51
PB1046 Injection, 0.6 mg/kgVital Signs - Respiratory RateDay 20.3 Breaths/minStandard Deviation 0.76
PB1046 Injection, 0.6 mg/kgVital Signs - Respiratory RateDay 30.3 Breaths/minStandard Deviation 2.14
PB1046 Injection, 0.6 mg/kgVital Signs - Respiratory RateDay 5-0.1 Breaths/minStandard Deviation 0.9
PB1046 Injection, 0.6 mg/kgVital Signs - Respiratory RateDay 21 1hr-0.3 Breaths/minStandard Deviation 1.51
PB1046 Injection, 0.6 mg/kgVital Signs - Respiratory RateDay 21 3 hr-0.3 Breaths/minStandard Deviation 1.97
PB1046 Injection, 0.6 mg/kgVital Signs - Respiratory RateDay 21 pre0.7 Breaths/minStandard Deviation 1.63
PB1046 Injection, 0.6 mg/kgVital Signs - Respiratory RateDay 220.0 Breaths/minStandard Deviation 2.19
PB1046 Injection, 0.6 mg/kgVital Signs - Respiratory RateDay 240.0 Breaths/minStandard Deviation 1.79
PB1046 Injection, 0.6 mg/kgVital Signs - Respiratory RateDay 260.0 Breaths/minStandard Deviation 1.79
PB1046 Injection, 0.6 mg/kgVital Signs - Respiratory RateDay 280.3 Breaths/minStandard Deviation 1.97
PB1046 Injection, 0.6 mg/kgVital Signs - Respiratory RateDay 29-0.3 Breaths/minStandard Deviation 1.51
PB1046 Injection, 0.6 mg/kgVital Signs - Respiratory RateDay 300.0 Breaths/minStandard Deviation 1.26
PB1046 Injection, 0.6 mg/kgVital Signs - Respiratory RateDay 490.7 Breaths/minStandard Deviation 1.03
PB1046 Injection, 1.2 mg/kgVital Signs - Respiratory RateDay 21 3 hr0.5 Breaths/minStandard Deviation 1
PB1046 Injection, 1.2 mg/kgVital Signs - Respiratory RateDay 21 1hr-0.5 Breaths/minStandard Deviation 1
PB1046 Injection, 1.2 mg/kgVital Signs - Respiratory RateDay 23-0.5 Breaths/minStandard Deviation 1
PB1046 Injection, 1.2 mg/kgVital Signs - Respiratory RateDay 50.3 Breaths/minStandard Deviation 0.082
PB1046 Injection, 1.2 mg/kgVital Signs - Respiratory RateDay 24-0.5 Breaths/minStandard Deviation 1
PB1046 Injection, 1.2 mg/kgVital Signs - Respiratory RateDay 30.3 Breaths/minStandard Deviation 1.51
PB1046 Injection, 1.2 mg/kgVital Signs - Respiratory RateDay 26-0.5 Breaths/minStandard Deviation 1
PB1046 Injection, 1.2 mg/kgVital Signs - Respiratory RateDay 2-0.3 Breaths/minStandard Deviation 1.51
PB1046 Injection, 1.2 mg/kgVital Signs - Respiratory RateDay 0 1 hr-0.3 Breaths/minStandard Deviation 1.51
PB1046 Injection, 1.2 mg/kgVital Signs - Respiratory RateDay 28-0.5 Breaths/minStandard Deviation 1
PB1046 Injection, 1.2 mg/kgVital Signs - Respiratory RateDay 1-1.0 Breaths/minStandard Deviation 1.1
PB1046 Injection, 1.2 mg/kgVital Signs - Respiratory RateDay 29-1.0 Breaths/minStandard Deviation 1.15
PB1046 Injection, 1.2 mg/kgVital Signs - Respiratory RateDay 0 3hr0.0 Breaths/minStandard Deviation 1.26
PB1046 Injection, 1.2 mg/kgVital Signs - Respiratory RateDay 490.0 Breaths/minStandard Deviation 1.26
PB1046 Injection, 1.2 mg/kgVital Signs - Respiratory RateDay 21 pre0.0 Breaths/minStandard Deviation 0
PB1046 Injection, 1.2 mg/kgVital Signs - Respiratory RateDay 30-1.0 Breaths/minStandard Deviation 1.15
PB1046 Injection, 1.2 mg/kgVital Signs - Respiratory RateDay 22-0.5 Breaths/minStandard Deviation 1
Placebo ComparatorVital Signs - Respiratory RateDay 220.2 Breaths/minStandard Deviation 2.28
Placebo ComparatorVital Signs - Respiratory RateDay 280.6 Breaths/minStandard Deviation 2.44
Placebo ComparatorVital Signs - Respiratory RateDay 10.3 Breaths/minStandard Deviation 1.25
Placebo ComparatorVital Signs - Respiratory RateDay 23-0.4 Breaths/minStandard Deviation 3.15
Placebo ComparatorVital Signs - Respiratory RateDay 50.6 Breaths/minStandard Deviation 1.62
Placebo ComparatorVital Signs - Respiratory RateDay 21 pre0.6 Breaths/minStandard Deviation 1.81
Placebo ComparatorVital Signs - Respiratory RateDay 300.3 Breaths/minStandard Deviation 2.43
Placebo ComparatorVital Signs - Respiratory RateDay 49-0.3 Breaths/minStandard Deviation 1.38
Placebo ComparatorVital Signs - Respiratory RateDay 240.2 Breaths/minStandard Deviation 1.56
Placebo ComparatorVital Signs - Respiratory RateDay 30.1 Breaths/minStandard Deviation 1.07
Placebo ComparatorVital Signs - Respiratory RateDay 21 1hr-0.4 Breaths/minStandard Deviation 3.05
Placebo ComparatorVital Signs - Respiratory RateDay 0 1 hr0.4 Breaths/minStandard Deviation 1.51
Placebo ComparatorVital Signs - Respiratory RateDay 29-0.3 Breaths/minStandard Deviation 2.06
Placebo ComparatorVital Signs - Respiratory RateDay 260.3 Breaths/minStandard Deviation 1.89
Placebo ComparatorVital Signs - Respiratory RateDay 2-0.1 Breaths/minStandard Deviation 1.81
Placebo ComparatorVital Signs - Respiratory RateDay 0 3hr0.8 Breaths/minStandard Deviation 1.83
Placebo ComparatorVital Signs - Respiratory RateDay 21 3 hr0.4 Breaths/minStandard Deviation 2.44
Primary

Vital Signs - Systolic Blood Pressure

Changes from baseline in vital signs (systolic blood pressure) and the relationship to PB1046 compared to placebo.

Time frame: Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.

Population: Safety/Intent-to-Treat/Per Protocol Population

ArmMeasureGroupValue (MEAN)Dispersion
PB1046 Injection, 0.2 mg/kgVital Signs - Systolic Blood PressureDay 3-6.7 mmHgStandard Deviation 8.25
PB1046 Injection, 0.2 mg/kgVital Signs - Systolic Blood PressureDay 26-8.7 mmHgStandard Deviation 8.02
PB1046 Injection, 0.2 mg/kgVital Signs - Systolic Blood PressureDay 21 pre-3.0 mmHgStandard Deviation 6.57
PB1046 Injection, 0.2 mg/kgVital Signs - Systolic Blood PressureDay 14 pre4.3 mmHgStandard Deviation 9.6
PB1046 Injection, 0.2 mg/kgVital Signs - Systolic Blood PressureDay 1-3.4 mmHgStandard Deviation 2.87
PB1046 Injection, 0.2 mg/kgVital Signs - Systolic Blood PressureDay 52.4 mmHgStandard Deviation 11.42
PB1046 Injection, 0.2 mg/kgVital Signs - Systolic Blood PressureDay 22-5.0 mmHgStandard Deviation 4.81
PB1046 Injection, 0.2 mg/kgVital Signs - Systolic Blood PressureDay 497.1 mmHgStandard Deviation 14.95
PB1046 Injection, 0.2 mg/kgVital Signs - Systolic Blood PressureDay 0 3 hr4.9 mmHgStandard Deviation 7.17
PB1046 Injection, 0.2 mg/kgVital Signs - Systolic Blood PressureDay 23-9.2 mmHgStandard Deviation 12.16
PB1046 Injection, 0.2 mg/kgVital Signs - Systolic Blood PressureDay 294.2 mmHgStandard Deviation 12.05
PB1046 Injection, 0.2 mg/kgVital Signs - Systolic Blood PressureDay 282.1 mmHgStandard Deviation 9.83
PB1046 Injection, 0.2 mg/kgVital Signs - Systolic Blood PressureDay 300.8 mmHgStandard Deviation 8
PB1046 Injection, 0.2 mg/kgVital Signs - Systolic Blood PressureDay 21 3 hr-7.9 mmHgStandard Deviation 4.4
PB1046 Injection, 0.2 mg/kgVital Signs - Systolic Blood PressureDay 0 1 hr7.4 mmHgStandard Deviation 10.88
PB1046 Injection, 0.2 mg/kgVital Signs - Systolic Blood PressureDay 2-0.6 mmHgStandard Deviation 7.07
PB1046 Injection, 0.2 mg/kgVital Signs - Systolic Blood PressureDay 240.9 mmHgStandard Deviation 5.5
PB1046 Injection, 0.2 mg/kgVital Signs - Systolic Blood PressureDay 7 pre-6.9 mmHgStandard Deviation 2.22
PB1046 Injection, 0.2 mg/kgVital Signs - Systolic Blood PressureDay 21 1 hr-7.9 mmHgStandard Deviation 4.4
PB1046 Injection, 0.2 mg/kgVital Signs - Systolic Blood PressureDay 31-3.4 mmHgStandard Deviation 1.35
PB1046 Injection, 0.4 mg/kgVital Signs - Systolic Blood PressureDay 26-11.6 mmHgStandard Deviation 8.41
PB1046 Injection, 0.4 mg/kgVital Signs - Systolic Blood PressureDay 24-1.9 mmHgStandard Deviation 9.19
PB1046 Injection, 0.4 mg/kgVital Signs - Systolic Blood PressureDay 29-7.4 mmHgStandard Deviation 15.88
PB1046 Injection, 0.4 mg/kgVital Signs - Systolic Blood PressureDay 7 pre-9.4 mmHgStandard Deviation 11.47
PB1046 Injection, 0.4 mg/kgVital Signs - Systolic Blood PressureDay 28-9.4 mmHgStandard Deviation 13.93
PB1046 Injection, 0.4 mg/kgVital Signs - Systolic Blood PressureDay 2-4.4 mmHgStandard Deviation 13.45
PB1046 Injection, 0.4 mg/kgVital Signs - Systolic Blood PressureDay 31.8 mmHgStandard Deviation 24.86
PB1046 Injection, 0.4 mg/kgVital Signs - Systolic Blood PressureDay 49-6.9 mmHgStandard Deviation 12.42
PB1046 Injection, 0.4 mg/kgVital Signs - Systolic Blood PressureDay 5-4.6 mmHgStandard Deviation 23.37
PB1046 Injection, 0.4 mg/kgVital Signs - Systolic Blood PressureDay 14 pre-8.0 mmHgStandard Deviation 14.73
PB1046 Injection, 0.4 mg/kgVital Signs - Systolic Blood PressureDay 0 3 hr-2.6 mmHgStandard Deviation 14.06
PB1046 Injection, 0.4 mg/kgVital Signs - Systolic Blood PressureDay 31-10.4 mmHgStandard Deviation 17.18
PB1046 Injection, 0.4 mg/kgVital Signs - Systolic Blood PressureDay 21 pre-8.4 mmHgStandard Deviation 9.37
PB1046 Injection, 0.4 mg/kgVital Signs - Systolic Blood PressureDay 21 1 hr-14.1 mmHgStandard Deviation 9.15
PB1046 Injection, 0.4 mg/kgVital Signs - Systolic Blood PressureDay 21 3 hr-14.1 mmHgStandard Deviation 9.15
PB1046 Injection, 0.4 mg/kgVital Signs - Systolic Blood PressureDay 0 1 hr-6.2 mmHgStandard Deviation 19.89
PB1046 Injection, 0.4 mg/kgVital Signs - Systolic Blood PressureDay 30-7.6 mmHgStandard Deviation 18.85
PB1046 Injection, 0.4 mg/kgVital Signs - Systolic Blood PressureDay 22-10.6 mmHgStandard Deviation 18.27
PB1046 Injection, 0.4 mg/kgVital Signs - Systolic Blood PressureDay 23-4.7 mmHgStandard Deviation 9.18
PB1046 Injection, 0.4 mg/kgVital Signs - Systolic Blood PressureDay 1-5.8 mmHgStandard Deviation 14.89
PB1046 Injection, 0.6 mg/kgVital Signs - Systolic Blood PressureDay 49-10.2 mmHgStandard Deviation 11.97
PB1046 Injection, 0.6 mg/kgVital Signs - Systolic Blood PressureDay 7 pre-5.9 mmHgStandard Deviation 13.47
PB1046 Injection, 0.6 mg/kgVital Signs - Systolic Blood PressureDay 22-9.4 mmHgStandard Deviation 10.46
PB1046 Injection, 0.6 mg/kgVital Signs - Systolic Blood PressureDay 21 1 hr-4.0 mmHgStandard Deviation 10
PB1046 Injection, 0.6 mg/kgVital Signs - Systolic Blood PressureDay 2-7.2 mmHgStandard Deviation 7.98
PB1046 Injection, 0.6 mg/kgVital Signs - Systolic Blood PressureDay 30-5.9 mmHgStandard Deviation 9.96
PB1046 Injection, 0.6 mg/kgVital Signs - Systolic Blood PressureDay 28-8.1 mmHgStandard Deviation 12.89
PB1046 Injection, 0.6 mg/kgVital Signs - Systolic Blood PressureDay 29-4.6 mmHgStandard Deviation 12.3
PB1046 Injection, 0.6 mg/kgVital Signs - Systolic Blood PressureDay 21 3 hr-4.0 mmHgStandard Deviation 10
PB1046 Injection, 0.6 mg/kgVital Signs - Systolic Blood PressureDay 51.5 mmHgStandard Deviation 8.57
PB1046 Injection, 0.6 mg/kgVital Signs - Systolic Blood PressureDay 31-9.3 mmHgStandard Deviation 9.45
PB1046 Injection, 0.6 mg/kgVital Signs - Systolic Blood PressureDay 0 1 hr3.1 mmHgStandard Deviation 8.17
PB1046 Injection, 0.6 mg/kgVital Signs - Systolic Blood PressureDay 1-2.3 mmHgStandard Deviation 4.79
PB1046 Injection, 0.6 mg/kgVital Signs - Systolic Blood PressureDay 14 pre-1.6 mmHgStandard Deviation 9.32
PB1046 Injection, 0.6 mg/kgVital Signs - Systolic Blood PressureDay 24-1.0 mmHgStandard Deviation 12.16
PB1046 Injection, 0.6 mg/kgVital Signs - Systolic Blood PressureDay 26-11.4 mmHgStandard Deviation 5.05
PB1046 Injection, 0.6 mg/kgVital Signs - Systolic Blood PressureDay 3-8.9 mmHgStandard Deviation 9.08
PB1046 Injection, 0.6 mg/kgVital Signs - Systolic Blood PressureDay 23-9.2 mmHgStandard Deviation 11.77
PB1046 Injection, 0.6 mg/kgVital Signs - Systolic Blood PressureDay 21 pre-1.6 mmHgStandard Deviation 9.32
PB1046 Injection, 0.6 mg/kgVital Signs - Systolic Blood PressureDay 0 3 hr1.3 mmHgStandard Deviation 6.52
PB1046 Injection, 1.2 mg/kgVital Signs - Systolic Blood PressureDay 0 1 hr-2.6 mmHgStandard Deviation 13.43
PB1046 Injection, 1.2 mg/kgVital Signs - Systolic Blood PressureDay 0 3 hr-8.7 mmHgStandard Deviation 6.24
PB1046 Injection, 1.2 mg/kgVital Signs - Systolic Blood PressureDay 1-15.4 mmHgStandard Deviation 18.17
PB1046 Injection, 1.2 mg/kgVital Signs - Systolic Blood PressureDay 2-8.9 mmHgStandard Deviation 12.63
PB1046 Injection, 1.2 mg/kgVital Signs - Systolic Blood PressureDay 3-17.8 mmHgStandard Deviation 18.09
PB1046 Injection, 1.2 mg/kgVital Signs - Systolic Blood PressureDay 5-11.7 mmHgStandard Deviation 20.19
PB1046 Injection, 1.2 mg/kgVital Signs - Systolic Blood PressureDay 14 pre-8.8 mmHgStandard Deviation 14.62
PB1046 Injection, 1.2 mg/kgVital Signs - Systolic Blood PressureDay 21 pre-8.8 mmHgStandard Deviation 14.62
PB1046 Injection, 1.2 mg/kgVital Signs - Systolic Blood PressureDay 21 1 hr-12.8 mmHgStandard Deviation 15.89
PB1046 Injection, 1.2 mg/kgVital Signs - Systolic Blood PressureDay 21 3 hr-12.8 mmHgStandard Deviation 15.89
PB1046 Injection, 1.2 mg/kgVital Signs - Systolic Blood PressureDay 22-20.8 mmHgStandard Deviation 17.19
PB1046 Injection, 1.2 mg/kgVital Signs - Systolic Blood PressureDay 23-8.0 mmHgStandard Deviation 4.33
PB1046 Injection, 1.2 mg/kgVital Signs - Systolic Blood PressureDay 24-21.6 mmHgStandard Deviation 29.51
PB1046 Injection, 1.2 mg/kgVital Signs - Systolic Blood PressureDay 26-9.6 mmHgStandard Deviation 19.51
PB1046 Injection, 1.2 mg/kgVital Signs - Systolic Blood PressureDay 28-6.3 mmHgStandard Deviation 20.28
PB1046 Injection, 1.2 mg/kgVital Signs - Systolic Blood PressureDay 29-8.9 mmHgStandard Deviation 7.54
PB1046 Injection, 1.2 mg/kgVital Signs - Systolic Blood PressureDay 30-11.0 mmHgStandard Deviation 15.48
PB1046 Injection, 1.2 mg/kgVital Signs - Systolic Blood PressureDay 31-12.8 mmHgStandard Deviation 14.83
PB1046 Injection, 1.2 mg/kgVital Signs - Systolic Blood PressureDay 49-16.8 mmHgStandard Deviation 22.45
PB1046 Injection, 1.2 mg/kgVital Signs - Systolic Blood PressureDay 7 pre-11.7 mmHgStandard Deviation 3.78
Placebo ComparatorVital Signs - Systolic Blood PressureDay 29-3.6 mmHgStandard Deviation 21.02
Placebo ComparatorVital Signs - Systolic Blood PressureDay 22-3.4 mmHgStandard Deviation 13.67
Placebo ComparatorVital Signs - Systolic Blood PressureDay 21 3 hr-3.0 mmHgStandard Deviation 9
Placebo ComparatorVital Signs - Systolic Blood PressureDay 21 1 hr-3.0 mmHgStandard Deviation 9
Placebo ComparatorVital Signs - Systolic Blood PressureDay 1-7.1 mmHgStandard Deviation 14.59
Placebo ComparatorVital Signs - Systolic Blood PressureDay 30-4.5 mmHgStandard Deviation 25.36
Placebo ComparatorVital Signs - Systolic Blood PressureDay 21 pre-5.1 mmHgStandard Deviation 13.04
Placebo ComparatorVital Signs - Systolic Blood PressureDay 14 pre-3.0 mmHgStandard Deviation 17.71
Placebo ComparatorVital Signs - Systolic Blood PressureDay 7 pre-0.3 mmHgStandard Deviation 10.73
Placebo ComparatorVital Signs - Systolic Blood PressureDay 0 3 hr3.4 mmHgStandard Deviation 11.57
Placebo ComparatorVital Signs - Systolic Blood PressureDay 31-0.2 mmHgStandard Deviation 13.98
Placebo ComparatorVital Signs - Systolic Blood PressureDay 51.3 mmHgStandard Deviation 10.44
Placebo ComparatorVital Signs - Systolic Blood PressureDay 3-1.8 mmHgStandard Deviation 16.75
Placebo ComparatorVital Signs - Systolic Blood PressureDay 2-2.9 mmHgStandard Deviation 23.54
Placebo ComparatorVital Signs - Systolic Blood PressureDay 0 1 hr4.6 mmHgStandard Deviation 17.41
Placebo ComparatorVital Signs - Systolic Blood PressureDay 28-1.2 mmHgStandard Deviation 21.19
Placebo ComparatorVital Signs - Systolic Blood PressureDay 26-4.5 mmHgStandard Deviation 14.75
Placebo ComparatorVital Signs - Systolic Blood PressureDay 242.0 mmHgStandard Deviation 20.23
Placebo ComparatorVital Signs - Systolic Blood PressureDay 23-0.8 mmHgStandard Deviation 11.38
Placebo ComparatorVital Signs - Systolic Blood PressureDay 49-3.0 mmHgStandard Deviation 14.78
Primary

Vital Signs - Temperature

Changes from baseline in vital signs (temperature) and the relationship to PB1046 compared to placebo.

Time frame: Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.

Population: Safety/Intent-to-Treat/Per Protocol Population

ArmMeasureGroupValue (MEAN)Dispersion
PB1046 Injection, 0.2 mg/kgVital Signs - TemperatureDay 290.1 CelsiusStandard Deviation 0.21
PB1046 Injection, 0.2 mg/kgVital Signs - TemperatureDay 3-1.2 CelsiusStandard Deviation 2.2
PB1046 Injection, 0.2 mg/kgVital Signs - TemperatureDay 0 1 hr0.0 CelsiusStandard Deviation 0.1
PB1046 Injection, 0.2 mg/kgVital Signs - TemperatureDay 0 3 hr-0.1 CelsiusStandard Deviation 0.06
PB1046 Injection, 0.2 mg/kgVital Signs - TemperatureDay 10.1 CelsiusStandard Deviation 0.12
PB1046 Injection, 0.2 mg/kgVital Signs - TemperatureDay 28-0.6 CelsiusStandard Deviation 1.42
PB1046 Injection, 0.2 mg/kgVital Signs - TemperatureDay 50.1 CelsiusStandard Deviation 0.21
PB1046 Injection, 0.2 mg/kgVital Signs - TemperatureDay 310.3 CelsiusStandard Deviation 0.25
PB1046 Injection, 0.2 mg/kgVital Signs - TemperatureDay 21 1 hr0.1 CelsiusStandard Deviation 0.36
PB1046 Injection, 0.2 mg/kgVital Signs - TemperatureDay 220.1 CelsiusStandard Deviation 0.31
PB1046 Injection, 0.2 mg/kgVital Signs - TemperatureDay 260.2 CelsiusStandard Deviation 0.15
PB1046 Injection, 0.2 mg/kgVital Signs - TemperatureDay 7 pre-0.1 CelsiusStandard Deviation 0.06
PB1046 Injection, 0.2 mg/kgVital Signs - TemperatureDay 30-1.0 CelsiusStandard Deviation 1.91
PB1046 Injection, 0.2 mg/kgVital Signs - TemperatureDay 2-1.1 CelsiusStandard Deviation 2.06
PB1046 Injection, 0.2 mg/kgVital Signs - TemperatureDay 21 3 hr0.1 CelsiusStandard Deviation 0.23
PB1046 Injection, 0.2 mg/kgVital Signs - TemperatureDay 240.3 CelsiusStandard Deviation 0.4
PB1046 Injection, 0.2 mg/kgVital Signs - TemperatureDay 14 pre-0.2 CelsiusStandard Deviation 0.49
PB1046 Injection, 0.2 mg/kgVital Signs - TemperatureDay 490.1 CelsiusStandard Deviation 0.36
PB1046 Injection, 0.2 mg/kgVital Signs - TemperatureDay 230.3 CelsiusStandard Deviation 0.25
PB1046 Injection, 0.4 mg/kgVital Signs - TemperatureDay 310.1 CelsiusStandard Deviation 0.57
PB1046 Injection, 0.4 mg/kgVital Signs - TemperatureDay 21 1 hr0.1 CelsiusStandard Deviation 0.48
PB1046 Injection, 0.4 mg/kgVital Signs - TemperatureDay 220.1 CelsiusStandard Deviation 0.24
PB1046 Injection, 0.4 mg/kgVital Signs - TemperatureDay 21 3 hr-0.2 CelsiusStandard Deviation 0.29
PB1046 Injection, 0.4 mg/kgVital Signs - TemperatureDay 1-0.3 CelsiusStandard Deviation 0.52
PB1046 Injection, 0.4 mg/kgVital Signs - TemperatureDay 490.1 CelsiusStandard Deviation 0.55
PB1046 Injection, 0.4 mg/kgVital Signs - TemperatureDay 30-0.1 CelsiusStandard Deviation 0.69
PB1046 Injection, 0.4 mg/kgVital Signs - TemperatureDay 2-0.5 CelsiusStandard Deviation 0.65
PB1046 Injection, 0.4 mg/kgVital Signs - TemperatureDay 29-0.3 CelsiusStandard Deviation 0.69
PB1046 Injection, 0.4 mg/kgVital Signs - TemperatureDay 3-0.2 CelsiusStandard Deviation 0.46
PB1046 Injection, 0.4 mg/kgVital Signs - TemperatureDay 280.2 CelsiusStandard Deviation 0.53
PB1046 Injection, 0.4 mg/kgVital Signs - TemperatureDay 5-0.2 CelsiusStandard Deviation 0.36
PB1046 Injection, 0.4 mg/kgVital Signs - TemperatureDay 0 3 hr-0.2 CelsiusStandard Deviation 0.36
PB1046 Injection, 0.4 mg/kgVital Signs - TemperatureDay 260.0 CelsiusStandard Deviation 0.66
PB1046 Injection, 0.4 mg/kgVital Signs - TemperatureDay 7 pre0.0 CelsiusStandard Deviation 1.22
PB1046 Injection, 0.4 mg/kgVital Signs - TemperatureDay 0 1 hr-0.1 CelsiusStandard Deviation 0.35
PB1046 Injection, 0.4 mg/kgVital Signs - TemperatureDay 240.1 CelsiusStandard Deviation 0.28
PB1046 Injection, 0.4 mg/kgVital Signs - TemperatureDay 14 pre-0.1 CelsiusStandard Deviation 0.39
PB1046 Injection, 0.4 mg/kgVital Signs - TemperatureDay 230.2 CelsiusStandard Deviation 0.25
PB1046 Injection, 0.6 mg/kgVital Signs - TemperatureDay 21 3 hr-0.1 CelsiusStandard Deviation 0.39
PB1046 Injection, 0.6 mg/kgVital Signs - TemperatureDay 0 1 hr0.0 CelsiusStandard Deviation 0.34
PB1046 Injection, 0.6 mg/kgVital Signs - TemperatureDay 0 3 hr0.0 CelsiusStandard Deviation 0.39
PB1046 Injection, 0.6 mg/kgVital Signs - TemperatureDay 1-0.1 CelsiusStandard Deviation 0.4
PB1046 Injection, 0.6 mg/kgVital Signs - TemperatureDay 2-0.0 CelsiusStandard Deviation 0.45
PB1046 Injection, 0.6 mg/kgVital Signs - TemperatureDay 30.0 CelsiusStandard Deviation 0.49
PB1046 Injection, 0.6 mg/kgVital Signs - TemperatureDay 50.1 CelsiusStandard Deviation 0.26
PB1046 Injection, 0.6 mg/kgVital Signs - TemperatureDay 7 pre0.1 CelsiusStandard Deviation 0.27
PB1046 Injection, 0.6 mg/kgVital Signs - TemperatureDay 14 pre0.2 CelsiusStandard Deviation 0.27
PB1046 Injection, 0.6 mg/kgVital Signs - TemperatureDay 21 1 hr0.0 CelsiusStandard Deviation 0.42
PB1046 Injection, 0.6 mg/kgVital Signs - TemperatureDay 220.2 CelsiusStandard Deviation 0.24
PB1046 Injection, 0.6 mg/kgVital Signs - TemperatureDay 230.1 CelsiusStandard Deviation 0.23
PB1046 Injection, 0.6 mg/kgVital Signs - TemperatureDay 240.2 CelsiusStandard Deviation 0.3
PB1046 Injection, 0.6 mg/kgVital Signs - TemperatureDay 260.1 CelsiusStandard Deviation 0.34
PB1046 Injection, 0.6 mg/kgVital Signs - TemperatureDay 28-0.2 CelsiusStandard Deviation 0.43
PB1046 Injection, 0.6 mg/kgVital Signs - TemperatureDay 290.0 CelsiusStandard Deviation 0.4
PB1046 Injection, 0.6 mg/kgVital Signs - TemperatureDay 300.1 CelsiusStandard Deviation 0.3
PB1046 Injection, 0.6 mg/kgVital Signs - TemperatureDay 310.1 CelsiusStandard Deviation 0.37
PB1046 Injection, 0.6 mg/kgVital Signs - TemperatureDay 490.1 CelsiusStandard Deviation 0.42
PB1046 Injection, 1.2 mg/kgVital Signs - TemperatureDay 14 pre0.1 CelsiusStandard Deviation 0.29
PB1046 Injection, 1.2 mg/kgVital Signs - TemperatureDay 230.1 CelsiusStandard Deviation 0.26
PB1046 Injection, 1.2 mg/kgVital Signs - TemperatureDay 7 pre0.0 CelsiusStandard Deviation 0.25
PB1046 Injection, 1.2 mg/kgVital Signs - TemperatureDay 31-0.2 CelsiusStandard Deviation 0.29
PB1046 Injection, 1.2 mg/kgVital Signs - TemperatureDay 24-0.1 CelsiusStandard Deviation 0.51
PB1046 Injection, 1.2 mg/kgVital Signs - TemperatureDay 50.1 CelsiusStandard Deviation 0.39
PB1046 Injection, 1.2 mg/kgVital Signs - TemperatureDay 26-0.1 CelsiusStandard Deviation 0.15
PB1046 Injection, 1.2 mg/kgVital Signs - TemperatureDay 30.1 CelsiusStandard Deviation 0.39
PB1046 Injection, 1.2 mg/kgVital Signs - TemperatureDay 280.3 CelsiusStandard Deviation 0.3
PB1046 Injection, 1.2 mg/kgVital Signs - TemperatureDay 20.1 CelsiusStandard Deviation 0.23
PB1046 Injection, 1.2 mg/kgVital Signs - TemperatureDay 0 1 hr0.0 CelsiusStandard Deviation 0.33
PB1046 Injection, 1.2 mg/kgVital Signs - TemperatureDay 290.1 CelsiusStandard Deviation 0.38
PB1046 Injection, 1.2 mg/kgVital Signs - TemperatureDay 10.3 CelsiusStandard Deviation 0.14
PB1046 Injection, 1.2 mg/kgVital Signs - TemperatureDay 300.0 CelsiusStandard Deviation 0.44
PB1046 Injection, 1.2 mg/kgVital Signs - TemperatureDay 21 3 hr-0.1 CelsiusStandard Deviation 0.36
PB1046 Injection, 1.2 mg/kgVital Signs - TemperatureDay 21 1 hr0.1 CelsiusStandard Deviation 0.34
PB1046 Injection, 1.2 mg/kgVital Signs - TemperatureDay 0 3 hr0.1 CelsiusStandard Deviation 0.24
PB1046 Injection, 1.2 mg/kgVital Signs - TemperatureDay 22-0.1 CelsiusStandard Deviation 0.22
PB1046 Injection, 1.2 mg/kgVital Signs - TemperatureDay 490.0 CelsiusStandard Deviation 0.43
Placebo ComparatorVital Signs - TemperatureDay 0 3 hr0.2 CelsiusStandard Deviation 0.53
Placebo ComparatorVital Signs - TemperatureDay 220.0 CelsiusStandard Deviation 0.49
Placebo ComparatorVital Signs - TemperatureDay 230.1 CelsiusStandard Deviation 0.48
Placebo ComparatorVital Signs - TemperatureDay 7 pre0.1 CelsiusStandard Deviation 0.37
Placebo ComparatorVital Signs - TemperatureDay 21 3 hr0.0 CelsiusStandard Deviation 0.55
Placebo ComparatorVital Signs - TemperatureDay 290.1 CelsiusStandard Deviation 0.52
Placebo ComparatorVital Signs - TemperatureDay 10.2 CelsiusStandard Deviation 0.38
Placebo ComparatorVital Signs - TemperatureDay 240.1 CelsiusStandard Deviation 0.47
Placebo ComparatorVital Signs - TemperatureDay 50.0 CelsiusStandard Deviation 0.52
Placebo ComparatorVital Signs - TemperatureDay 21 1 hr0.1 CelsiusStandard Deviation 0.5
Placebo ComparatorVital Signs - TemperatureDay 31-0.1 CelsiusStandard Deviation 0.73
Placebo ComparatorVital Signs - TemperatureDay 498.7 CelsiusStandard Deviation 22.71
Placebo ComparatorVital Signs - TemperatureDay 260.0 CelsiusStandard Deviation 0.44
Placebo ComparatorVital Signs - TemperatureDay 30.0 CelsiusStandard Deviation 0.66
Placebo ComparatorVital Signs - TemperatureDay 14 pre0.1 CelsiusStandard Deviation 0.48
Placebo ComparatorVital Signs - TemperatureDay 0 1 hr-0.1 CelsiusStandard Deviation 0.28
Placebo ComparatorVital Signs - TemperatureDay 300.1 CelsiusStandard Deviation 0.51
Placebo ComparatorVital Signs - TemperatureDay 280.0 CelsiusStandard Deviation 0.44
Placebo ComparatorVital Signs - TemperatureDay 2-0.1 CelsiusStandard Deviation 0.59
Secondary

Immunogenicity

Number of participants reporting positive immunogenicity (four-fold increase of pre-dose titer)

Time frame: Eleven weeks starting the first week of dosing.

Population: Safety/Intent-to-Treat/Per Protocol Population

ArmMeasureValue (NUMBER)
PB1046 Injection, 0.2 mg/kgImmunogenicity2 subjects
PB1046 Injection, 0.4 mg/kgImmunogenicity2 subjects
PB1046 Injection, 0.6 mg/kgImmunogenicity3 subjects
PB1046 Injection, 1.2 mg/kgImmunogenicity6 subjects
Placebo ComparatorImmunogenicity0 subjects
Secondary

Pharmacokinetic Profile - Area Under the Curve Over the Dosing Interval [AUC(0-t)]

Comparison of dose exposures \[AUC(0-t)\] during once weekly administration of various doses of PB1046

Time frame: Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.

Population: Safety/Intent-to-Treat/Per Protocol Population. Only subjects with sufficient data analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
PB1046 Injection, 0.2 mg/kgPharmacokinetic Profile - Area Under the Curve Over the Dosing Interval [AUC(0-t)]Week 15791.391 h*ng/mLStandard Error 1639.3
PB1046 Injection, 0.2 mg/kgPharmacokinetic Profile - Area Under the Curve Over the Dosing Interval [AUC(0-t)]Week 47440.721 h*ng/mLStandard Error 6183.8
PB1046 Injection, 0.4 mg/kgPharmacokinetic Profile - Area Under the Curve Over the Dosing Interval [AUC(0-t)]Week 419007.517 h*ng/mLStandard Error 12655.5
PB1046 Injection, 0.4 mg/kgPharmacokinetic Profile - Area Under the Curve Over the Dosing Interval [AUC(0-t)]Week 112382.716 h*ng/mLStandard Error 4869.3
PB1046 Injection, 0.6 mg/kgPharmacokinetic Profile - Area Under the Curve Over the Dosing Interval [AUC(0-t)]Week 114789.912 h*ng/mLStandard Error 4269.7
PB1046 Injection, 0.6 mg/kgPharmacokinetic Profile - Area Under the Curve Over the Dosing Interval [AUC(0-t)]Week 416689.657 h*ng/mLStandard Error 7313
PB1046 Injection, 1.2 mg/kgPharmacokinetic Profile - Area Under the Curve Over the Dosing Interval [AUC(0-t)]Week 125555.798 h*ng/mLStandard Error 11248.6
PB1046 Injection, 1.2 mg/kgPharmacokinetic Profile - Area Under the Curve Over the Dosing Interval [AUC(0-t)]Week 421997.727 h*ng/mLStandard Error 7709.6
Secondary

Pharmacokinetic Profile - Clearance (CL/F), Uncorrected for Bioavailability

Comparison of dose exposures (CL/F) during once weekly administration of various doses of PB1046

Time frame: Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.

Population: Safety/Intent-to-Treat/Per Protocol Population. Only subjects with sufficient data analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
PB1046 Injection, 0.2 mg/kgPharmacokinetic Profile - Clearance (CL/F), Uncorrected for BioavailabilityWeek 131.992 mL/h/kgStandard Error 10.1
PB1046 Injection, 0.2 mg/kgPharmacokinetic Profile - Clearance (CL/F), Uncorrected for BioavailabilityWeek 426.981 mL/h/kgStandard Error 16.2
PB1046 Injection, 0.4 mg/kgPharmacokinetic Profile - Clearance (CL/F), Uncorrected for BioavailabilityWeek 428.443 mL/h/kgStandard Error 16.7
PB1046 Injection, 0.4 mg/kgPharmacokinetic Profile - Clearance (CL/F), Uncorrected for BioavailabilityWeek 133.145 mL/h/kgStandard Error 11.8
PB1046 Injection, 0.6 mg/kgPharmacokinetic Profile - Clearance (CL/F), Uncorrected for BioavailabilityWeek 137.376 mL/h/kgStandard Error 8.2
PB1046 Injection, 0.6 mg/kgPharmacokinetic Profile - Clearance (CL/F), Uncorrected for BioavailabilityWeek 439.940 mL/h/kgStandard Error 17.7
PB1046 Injection, 1.2 mg/kgPharmacokinetic Profile - Clearance (CL/F), Uncorrected for BioavailabilityWeek 136.067 mL/h/kgStandard Error 15
PB1046 Injection, 1.2 mg/kgPharmacokinetic Profile - Clearance (CL/F), Uncorrected for BioavailabilityWeek 449.220 mL/h/kgStandard Error 11.3
Secondary

Pharmacokinetic Profile - Elimination Half-life (t½)

Comparison of dose exposures (t½) during once weekly administration of various doses of PB1046

Time frame: Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.

Population: Safety/Intent-to-Treat/Per Protocol Population. Only subjects with sufficient data analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
PB1046 Injection, 0.2 mg/kgPharmacokinetic Profile - Elimination Half-life (t½)Week 145.787 hoursStandard Error 4.7
PB1046 Injection, 0.2 mg/kgPharmacokinetic Profile - Elimination Half-life (t½)Week 478.382 hoursStandard Error 69.3
PB1046 Injection, 0.4 mg/kgPharmacokinetic Profile - Elimination Half-life (t½)Week 428.333 hoursStandard Error 6.5
PB1046 Injection, 0.4 mg/kgPharmacokinetic Profile - Elimination Half-life (t½)Week 140.806 hoursStandard Error 7.8
PB1046 Injection, 0.6 mg/kgPharmacokinetic Profile - Elimination Half-life (t½)Week 154.735 hoursStandard Error 35.8
PB1046 Injection, 0.6 mg/kgPharmacokinetic Profile - Elimination Half-life (t½)Week 434.602 hoursStandard Error 8.5
PB1046 Injection, 1.2 mg/kgPharmacokinetic Profile - Elimination Half-life (t½)Week 1103.951 hoursStandard Error 94.6
PB1046 Injection, 1.2 mg/kgPharmacokinetic Profile - Elimination Half-life (t½)Week 444.902 hoursStandard Error 28.5
Secondary

Pharmacokinetic Profile - Elimination Rate Constant (Lambda z)

Comparison of dose exposures (lambda z) during once weekly administration of various doses of PB1046

Time frame: Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.

Population: Safety/Intent-to-Treat/Per Protocol Population. Only subjects with sufficient data analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
PB1046 Injection, 0.2 mg/kgPharmacokinetic Profile - Elimination Rate Constant (Lambda z)Week 10.015 1/hourStandard Error 0
PB1046 Injection, 0.2 mg/kgPharmacokinetic Profile - Elimination Rate Constant (Lambda z)Week 40.015 1/hourStandard Error 0
PB1046 Injection, 0.4 mg/kgPharmacokinetic Profile - Elimination Rate Constant (Lambda z)Week 40.026 1/hourStandard Error 0
PB1046 Injection, 0.4 mg/kgPharmacokinetic Profile - Elimination Rate Constant (Lambda z)Week 10.018 1/hourStandard Error 0
PB1046 Injection, 0.6 mg/kgPharmacokinetic Profile - Elimination Rate Constant (Lambda z)Week 10.017 1/hourStandard Error 0
PB1046 Injection, 0.6 mg/kgPharmacokinetic Profile - Elimination Rate Constant (Lambda z)Week 40.021 1/hourStandard Error 0
PB1046 Injection, 1.2 mg/kgPharmacokinetic Profile - Elimination Rate Constant (Lambda z)Week 10.010 1/hourStandard Error 0
PB1046 Injection, 1.2 mg/kgPharmacokinetic Profile - Elimination Rate Constant (Lambda z)Week 40.019 1/hourStandard Error 0
Secondary

Pharmacokinetic Profile - Maximum Serum Concentration (Cmax)

Comparison of dose exposures (Cmax) during once weekly administration of various doses of PB1046

Time frame: Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.

Population: Safety/Intent-to-Treat/Per Protocol Population. Only subjects with sufficient data analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
PB1046 Injection, 0.2 mg/kgPharmacokinetic Profile - Maximum Serum Concentration (Cmax)Week 147.433 ng/mLStandard Error 17.3
PB1046 Injection, 0.2 mg/kgPharmacokinetic Profile - Maximum Serum Concentration (Cmax)Week 453.600 ng/mLStandard Error 40.2
PB1046 Injection, 0.4 mg/kgPharmacokinetic Profile - Maximum Serum Concentration (Cmax)Week 4233.450 ng/mLStandard Error 189.6
PB1046 Injection, 0.4 mg/kgPharmacokinetic Profile - Maximum Serum Concentration (Cmax)Week 1128.317 ng/mLStandard Error 64.1
PB1046 Injection, 0.6 mg/kgPharmacokinetic Profile - Maximum Serum Concentration (Cmax)Week 1218.471 ng/mLStandard Error 106.3
PB1046 Injection, 0.6 mg/kgPharmacokinetic Profile - Maximum Serum Concentration (Cmax)Week 4211.967 ng/mLStandard Error 110.1
PB1046 Injection, 1.2 mg/kgPharmacokinetic Profile - Maximum Serum Concentration (Cmax)Week 1207.600 ng/mLStandard Error 112.3
PB1046 Injection, 1.2 mg/kgPharmacokinetic Profile - Maximum Serum Concentration (Cmax)Week 4239.000 ng/mLStandard Error 102.6
Secondary

Pharmacokinetic Profile - Time to Cmax (Tmax)

Comparison of dose exposures (Tmax) during once weekly administration of various doses of PB1046

Time frame: Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.

Population: Safety/Intent-to-Treat/Per Protocol Population. Only subjects with sufficient data analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
PB1046 Injection, 0.2 mg/kgPharmacokinetic Profile - Time to Cmax (Tmax)Week 139.533 hoursStandard Error 14.1
PB1046 Injection, 0.2 mg/kgPharmacokinetic Profile - Time to Cmax (Tmax)Week 432.028 hoursStandard Error 13.7
PB1046 Injection, 0.4 mg/kgPharmacokinetic Profile - Time to Cmax (Tmax)Week 432.042 hoursStandard Error 12.2
PB1046 Injection, 0.4 mg/kgPharmacokinetic Profile - Time to Cmax (Tmax)Week 157.594 hoursStandard Error 54
PB1046 Injection, 0.6 mg/kgPharmacokinetic Profile - Time to Cmax (Tmax)Week 127.645 hoursStandard Error 15.7
PB1046 Injection, 0.6 mg/kgPharmacokinetic Profile - Time to Cmax (Tmax)Week 436.153 hoursStandard Error 13.6
PB1046 Injection, 1.2 mg/kgPharmacokinetic Profile - Time to Cmax (Tmax)Week 155.578 hoursStandard Error 35.8
PB1046 Injection, 1.2 mg/kgPharmacokinetic Profile - Time to Cmax (Tmax)Week 435.804 hoursStandard Error 13.9
Secondary

Pharmacokinetic Profile - Volume of Distribution (Vz/F), Uncorrected for Bioavailability (F)

Comparison of dose exposures (Vz/F) during once weekly administration of various doses of PB1046

Time frame: Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.

Population: Safety/Intent-to-Treat/Per Protocol Population. Only subjects with sufficient data analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
PB1046 Injection, 0.2 mg/kgPharmacokinetic Profile - Volume of Distribution (Vz/F), Uncorrected for Bioavailability (F)Week 12079.049 mL/kgStandard Error 451.5
PB1046 Injection, 0.2 mg/kgPharmacokinetic Profile - Volume of Distribution (Vz/F), Uncorrected for Bioavailability (F)Week 43860.362 mL/kgStandard Error 4528.5
PB1046 Injection, 0.4 mg/kgPharmacokinetic Profile - Volume of Distribution (Vz/F), Uncorrected for Bioavailability (F)Week 41246.900 mL/kgStandard Error 979.1
PB1046 Injection, 0.4 mg/kgPharmacokinetic Profile - Volume of Distribution (Vz/F), Uncorrected for Bioavailability (F)Week 11955.795 mL/kgStandard Error 826.8
PB1046 Injection, 0.6 mg/kgPharmacokinetic Profile - Volume of Distribution (Vz/F), Uncorrected for Bioavailability (F)Week 12983.922 mL/kgStandard Error 1951.6
PB1046 Injection, 0.6 mg/kgPharmacokinetic Profile - Volume of Distribution (Vz/F), Uncorrected for Bioavailability (F)Week 42122.745 mL/kgStandard Error 1412.1
PB1046 Injection, 1.2 mg/kgPharmacokinetic Profile - Volume of Distribution (Vz/F), Uncorrected for Bioavailability (F)Week 14774.976 mL/kgStandard Error 3297.6
PB1046 Injection, 1.2 mg/kgPharmacokinetic Profile - Volume of Distribution (Vz/F), Uncorrected for Bioavailability (F)Week 43401.624 mL/kgStandard Error 2650.3

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026