Moderate Asthma
Conditions
Keywords
Asthma, CAT-354, Tralokinumab
Brief summary
The study includes participants with moderate asthma who were randomly assigned to receive the study medication (CAT-354) or placebo.
Detailed description
This study is a randomized, double-blind, placebo controlled study. Following confirmation of eligibility, subjects with moderate asthma will be recruited sequentially to one of three dose groups and randomly assigned within dose group to either CAT-354 or placebo. Doses of the assigned treatment will be administered on three occasions 28 days apart. Follow up for pharmacokinetic blood sampling and safety will continue to Day 147 post-first dose (91 days post-third dose).
Interventions
BIOLOGICALCAT-354 1mg/kg
CAT-354 1 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
BIOLOGICALCAT-354 5 mg/kg
CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
BIOLOGICALCAT-354 10mg/kg
CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
OTHERPlacebo
Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Males or infertile females * Subjects with asthma, well controlled on inhaled corticosteroid and taken as required (PRN) short acting beta 2 agonist therapy only * Unchanged dose of inhaled corticosteroid for 3 months prior to Day 0 and no expected need for change in dose during study * Forced expiratory volume in 1 second (FEV1) greater than or equal to 80% predicted at Screening (Baseline) * 18-60 years * General Practitioner diagnosis of asthma of 1 year's minimum duration (with respect to Day 0) * No significant abnormality on clinical examination or medical history (excluding atopic skin signs, symptoms and history) * 12-lead electrocardiogram with no clinical significant abnormality * Clinical chemistry hematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator * A negative screen for drugs of abuse and alcohol * Body weight between 50-120 kg * Subjects aged between 18-40 years inclusive must have body mass index (BMI) 18-32 kilogram per square meter (kg/m\^2) inclusive. Subjects aged between 41-60 years must have BMI between 18-30 kg/m\^2 inclusive.
Exclusion criteria
* Active concomitant disease, with exception of eczema * Expected onset of seasonal allergy before the administration of the last dose of study medication * History of severe exacerbation within 3 years of Day 0 * Recorded use of inhaled short acting beta 2 agonist medication for symptoms within 14 days of Day 0 of: More than 6 doses per day on any 1 day or more than 3 doses per day on 6 or more days * Any medication other than: inhaled short-acting beta 2 agonist, inhaled corticosteroids, topic eczema treatments (with the exception of fluorinated corticosteroid, dermatological preparations which are not permitted), hormone replacement therapy, vitamin preparation/food supplements, occasional use of proton pump inhibitors, ranitidine, cimetidine, antacids or over-the-counter analgesics * Treatment within 6 months of Day 0 with any of the following: methylxanthines, inhaled cromones, leukotriene modifiers, anti- immunoglobulin E (IgE), anticholinergics, ketotifen, oral short acting B2 agonists, long-acting B2 agonists, oral or injected corticosteroids * Treatment of atopic symptoms, other than eczema, within 4 weeks of Day 0 * History of medication that might carry-over effects into the study * Previously received monoclonal antibody, or a similar related protein, that might sensitize to CAT-354 * Participation in another study within three months of the start of the study or 5 half lives of the previously administered investigational medicinal product (IMP), whichever is longer * Lower respiratory tract infection within 4 weeks of Day-14 * Any acute illness in the two weeks before Day 0 * Current smokers, those who have smoked in previous year, and those with smoking history of greater than or equal to 10 pack years * Considered by the investigator to be at risk of transmitting, through blood, the agents responsible for infectious diseases * Blood donation (550 ml) in the previous 2 months * Excessive intake of alcohol (more than 21 units a week for females or 28 units a week for males) * The subject's general practitioner has suggested a reason the subject should not participate in the study * The Investigator considers the subject should not take part for any reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accumulation Ratio (R0) for CAT-354 | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0 and 56; Pre-dose on Day 28; Day 4, 7, 14, 21, 63 and 84 | Accumulation ratio is calculated as: R0 = AUC(56 - 84)/AUC(0 - 28) where AUC(0 - 28) and AUC(56 - 84) are the area under the serum concentration time curve over a dosage interval determined after the first dose (Day 0 to Day 28) and after the third dose (Day 56 to Day 84), respectively. |
| Maximum Observed Serum Concentration (Cmax) for CAT-354 After First Dose | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21 | — |
| Maximum Observed Serum Concentration (Cmax) for CAT-354 After Second Dose | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 28; Day 35 | — |
| Maximum Observed Serum Concentration (Cmax) for CAT-354 After Third Dose | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 56; Day 63, 84, 105 and 147 | — |
| Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - t]) for CAT-354 After First Dose | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21 | — |
| Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0 - Infinity]) for CAT-354 After First Dose | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21 | AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity). |
| Apparent Terminal Elimination Phase Half-Life (t[1/2]el) for CAT-354 After First Dose | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21 | Terminal elimination phase half-life is the time measured for the serum concentration to decrease by one half. |
| Clearance (CL) for CAT-354 After First Dose | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21 | Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Clearance was normalized by the body weight of the participant. |
| Volume of Distribution (Vd) for CAT-354 After First Dose | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21 | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Volume of distribution was normalized to the body weight of the participant. |
| Observed Serum Drug Concentration for CAT-354 28 Days (C28) After First Dose | Pre-dose on Day 28 | — |
| Observed Serum Drug Concentration for CAT-354 28 Days (C28) After Second Dose | Pre-dose on Day 56 | — |
| Observed Serum Concentration for CAT-354 28 Days (C28) After Third Dose | Day 84 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Day 0 to Day 147 | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 147 that were absent before treatment or that worsened relative to pre-treatment state. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CAT-354 1 mg/kg CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. | 8 |
| CAT-354 5 mg/kg CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. | 8 |
| CAT-354 10 mg/kg CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. | 3 |
| Placebo Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56. | 4 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 1 | 1 |
| Overall Study | Participant on holiday; unable to attend | 0 | 0 | 0 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | CAT-354 1 mg/kg | CAT-354 5 mg/kg | CAT-354 10 mg/kg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 39.4 years STANDARD_DEVIATION 9.07 | 34.6 years STANDARD_DEVIATION 7.58 | 43.3 years STANDARD_DEVIATION 14.47 | 40.0 years STANDARD_DEVIATION 13.04 | 38.3 years STANDARD_DEVIATION 9.8 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 2 Participants | 4 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 8 | 8 / 8 | 3 / 3 | 4 / 4 |
| serious Total, serious adverse events | 0 / 8 | 1 / 8 | 0 / 3 | 0 / 4 |
Outcome results
Primary
Accumulation Ratio (R0) for CAT-354
Accumulation ratio is calculated as: R0 = AUC(56 - 84)/AUC(0 - 28) where AUC(0 - 28) and AUC(56 - 84) are the area under the serum concentration time curve over a dosage interval determined after the first dose (Day 0 to Day 28) and after the third dose (Day 56 to Day 84), respectively.
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0 and 56; Pre-dose on Day 28; Day 4, 7, 14, 21, 63 and 84
Population: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAT-354 1 mg/kg | Accumulation Ratio (R0) for CAT-354 | 1.58 ratio | Standard Deviation 0.21 |
| CAT-354 5 mg/kg | Accumulation Ratio (R0) for CAT-354 | 1.39 ratio | Standard Deviation 0.1 |
| CAT-354 10 mg/kg | Accumulation Ratio (R0) for CAT-354 | 1.67 ratio | — |
Primary
Apparent Terminal Elimination Phase Half-Life (t[1/2]el) for CAT-354 After First Dose
Terminal elimination phase half-life is the time measured for the serum concentration to decrease by one half.
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
Population: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAT-354 1 mg/kg | Apparent Terminal Elimination Phase Half-Life (t[1/2]el) for CAT-354 After First Dose | 16.6 days | Standard Deviation 2.67 |
| CAT-354 5 mg/kg | Apparent Terminal Elimination Phase Half-Life (t[1/2]el) for CAT-354 After First Dose | 16.1 days | Standard Deviation 3.6 |
| CAT-354 10 mg/kg | Apparent Terminal Elimination Phase Half-Life (t[1/2]el) for CAT-354 After First Dose | 11.8 days | Standard Deviation 1.86 |
Primary
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0 - Infinity]) for CAT-354 After First Dose
AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
Population: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAT-354 1 mg/kg | Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0 - Infinity]) for CAT-354 After First Dose | 428.0 (mcg*day)/mL | Standard Deviation 83.33 |
| CAT-354 5 mg/kg | Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0 - Infinity]) for CAT-354 After First Dose | 2314.3 (mcg*day)/mL | Standard Deviation 392.91 |
| CAT-354 10 mg/kg | Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0 - Infinity]) for CAT-354 After First Dose | 3861.3 (mcg*day)/mL | Standard Deviation 662.42 |
Primary
Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - t]) for CAT-354 After First Dose
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
Population: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAT-354 1 mg/kg | Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - t]) for CAT-354 After First Dose | 299.6 (mcg*day)/mL | Standard Deviation 42.03 |
| CAT-354 5 mg/kg | Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - t]) for CAT-354 After First Dose | 1691.3 (mcg*day)/mL | Standard Deviation 302.7 |
| CAT-354 10 mg/kg | Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - t]) for CAT-354 After First Dose | 3106.3 (mcg*day)/mL | Standard Deviation 719.25 |
Primary
Clearance (CL) for CAT-354 After First Dose
Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Clearance was normalized by the body weight of the participant.
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
Population: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAT-354 1 mg/kg | Clearance (CL) for CAT-354 After First Dose | 2.41 (mL/day)/kilogram | Standard Deviation 0.45 |
| CAT-354 5 mg/kg | Clearance (CL) for CAT-354 After First Dose | 2.23 (mL/day)/kilogram | Standard Deviation 0.46 |
| CAT-354 10 mg/kg | Clearance (CL) for CAT-354 After First Dose | 2.64 (mL/day)/kilogram | Standard Deviation 0.42 |
Primary
Maximum Observed Serum Concentration (Cmax) for CAT-354 After First Dose
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
Population: Pharmacokinetic (PK) population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAT-354 1 mg/kg | Maximum Observed Serum Concentration (Cmax) for CAT-354 After First Dose | 30.3 microgram/milliliter (mcg/mL) | Standard Deviation 5.18 |
| CAT-354 5 mg/kg | Maximum Observed Serum Concentration (Cmax) for CAT-354 After First Dose | 156.8 microgram/milliliter (mcg/mL) | Standard Deviation 34.55 |
| CAT-354 10 mg/kg | Maximum Observed Serum Concentration (Cmax) for CAT-354 After First Dose | 306.3 microgram/milliliter (mcg/mL) | Standard Deviation 31.39 |
Primary
Maximum Observed Serum Concentration (Cmax) for CAT-354 After Second Dose
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 28; Day 35
Population: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAT-354 1 mg/kg | Maximum Observed Serum Concentration (Cmax) for CAT-354 After Second Dose | 35.0 mcg/mL | Standard Deviation 6.81 |
| CAT-354 5 mg/kg | Maximum Observed Serum Concentration (Cmax) for CAT-354 After Second Dose | 161.0 mcg/mL | Standard Deviation 32.81 |
| CAT-354 10 mg/kg | Maximum Observed Serum Concentration (Cmax) for CAT-354 After Second Dose | 298.0 mcg/mL | — |
Primary
Maximum Observed Serum Concentration (Cmax) for CAT-354 After Third Dose
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 56; Day 63, 84, 105 and 147
Population: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAT-354 1 mg/kg | Maximum Observed Serum Concentration (Cmax) for CAT-354 After Third Dose | 41.1 mcg/mL | Standard Deviation 4.77 |
| CAT-354 5 mg/kg | Maximum Observed Serum Concentration (Cmax) for CAT-354 After Third Dose | 178.7 mcg/mL | Standard Deviation 25.41 |
| CAT-354 10 mg/kg | Maximum Observed Serum Concentration (Cmax) for CAT-354 After Third Dose | 393.0 mcg/mL | — |
Primary
Observed Serum Concentration for CAT-354 28 Days (C28) After Third Dose
Time frame: Day 84
Population: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAT-354 1 mg/kg | Observed Serum Concentration for CAT-354 28 Days (C28) After Third Dose | 8.6 mcg/mL | Standard Deviation 1.99 |
| CAT-354 5 mg/kg | Observed Serum Concentration for CAT-354 28 Days (C28) After Third Dose | 40.6 mcg/mL | Standard Deviation 12.26 |
| CAT-354 10 mg/kg | Observed Serum Concentration for CAT-354 28 Days (C28) After Third Dose | 79.6 mcg/mL | — |
Primary
Observed Serum Drug Concentration for CAT-354 28 Days (C28) After First Dose
Time frame: Pre-dose on Day 28
Population: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAT-354 1 mg/kg | Observed Serum Drug Concentration for CAT-354 28 Days (C28) After First Dose | 5.3 mcg/mL | Standard Deviation 1.33 |
| CAT-354 5 mg/kg | Observed Serum Drug Concentration for CAT-354 28 Days (C28) After First Dose | 27.1 mcg/mL | Standard Deviation 4.91 |
| CAT-354 10 mg/kg | Observed Serum Drug Concentration for CAT-354 28 Days (C28) After First Dose | 40.7 mcg/mL | — |
Primary
Observed Serum Drug Concentration for CAT-354 28 Days (C28) After Second Dose
Time frame: Pre-dose on Day 56
Population: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAT-354 1 mg/kg | Observed Serum Drug Concentration for CAT-354 28 Days (C28) After Second Dose | 7.7 mcg/mL | Standard Deviation 1.63 |
| CAT-354 5 mg/kg | Observed Serum Drug Concentration for CAT-354 28 Days (C28) After Second Dose | 36.0 mcg/mL | Standard Deviation 11.51 |
| CAT-354 10 mg/kg | Observed Serum Drug Concentration for CAT-354 28 Days (C28) After Second Dose | 59.4 mcg/mL | — |
Primary
Volume of Distribution (Vd) for CAT-354 After First Dose
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Volume of distribution was normalized to the body weight of the participant.
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
Population: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAT-354 1 mg/kg | Volume of Distribution (Vd) for CAT-354 After First Dose | 56.7 mL/kg | Standard Deviation 8.04 |
| CAT-354 5 mg/kg | Volume of Distribution (Vd) for CAT-354 After First Dose | 51.0 mL/kg | Standard Deviation 10.36 |
| CAT-354 10 mg/kg | Volume of Distribution (Vd) for CAT-354 After First Dose | 44.0 mL/kg | Standard Deviation 0.79 |
Secondary
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 147 that were absent before treatment or that worsened relative to pre-treatment state.
Time frame: Day 0 to Day 147
Population: Safety population included all participants who received at least 1 dose of IMP (CAT-354 or placebo) including those who did not complete the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAT-354 1 mg/kg | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 8 participants |
| CAT-354 1 mg/kg | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| CAT-354 5 mg/kg | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 1 participants |
| CAT-354 5 mg/kg | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 8 participants |
| CAT-354 10 mg/kg | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 3 participants |
| CAT-354 10 mg/kg | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| Placebp | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 4 participants |
| Placebp | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |