A Study to Evaluate the Drug Levels of Cendakimab Delivered Subcutaneously in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the drug levels of cendakimab delivered subcutaneously in healthy participants.

Official Title
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A Phase I, Open-Label, Randomized, Two-part Parallel Study to Compare the Pharmacokinetics of Single Subcutaneous Injections of Cendakimab Administered Using Autoinjector Versus Using Prefilled Syringe, and to Evaluate the Pharmacokinetics of Cendakimab When Administered by Autoinjector at Different Injection Sites, in Healthy Participants

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Cendakimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy participants as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, ECGs, and clinical laboratory determinations Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive. BMI = weight (kg)/[height (m)]2 Body weight ≥40.0 kg Exclusion Criteria: History of clinically significant infection within 4 weeks of dosing on Day 1 Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population History of clinically significant allergic reaction to any drug, biologic, food or vaccine Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br> | Drug: Cendakimab<br>* Specified Dose on Specified Days<br>* Other names: RPC4046;|
| Experimental: Part 2<br> | Drug: Cendakimab<br>* Specified Dose on Specified Days<br>* Other names: RPC4046;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed concentration (Cmax) |  | Up to Day 105 | 
| Area under the concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC(0-T)) |  | Up to Day 105 | 
| AUC from time zero extrapolated to infinite time (AUC(INF)) |  | Up to Day 105 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment emergent adverse events (TEAEs) |  | Up to Day 107 | 
| Number of Participants with Adverse Events (AEs) |  | Up to Day 107 | 
| Number of participants with clinical laboratory abnormalities |  | Up to Day 107 | 
| Number of participants with vital sign abnormalities |  | Up to Day 107 | 
| Number of participants with physical examination abnormalities |  | Up to Day 107 | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to Day 107 | 
| Number of participants with concomitant medications |  | Up to Day 107 | 
| Number of participants with concomitant procedures |  | Up to Day 107 | 
| Time of maximum observed concentration (Tmax) |  | Up to Day 105 | 
| Terminal half-life (T-HALF) |  | Up to Day 105 | 
| Apparent total body clearance (CL/F) |  | Up to Day 105 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Cendakimab