A Study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered With a Safety Syringe Device (SSD) or an Autoinjector in Healthy Adult Participants

Study Overview
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Brief Summary
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This study will compare the pharmacokinetics, safety, tolerability, and immunogenicity of Depemokimab administered via a SSD or autoinjector in healthy participants.

Official Title
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An Open-Label, Randomized, Single-Dose, Multicenter, Parallel-Group Study to Compare the Pharmacokinetics of Subcutaneous Depemokimab When Delivered With a Safety Syringe Device or an Autoinjector in Healthy Adult Participants

Conditions
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Asthma

Intervention / Treatment
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* Biological: Depemokimab


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiogram results. Body weight greater than or equal to (>=) 50 kilograms (kg) (110 pounds-mass/Ibs) and body mass index within the range 19 to 30 kg per meter square (inclusive). Women who have the potential to become pregnant must use a form of highly-effective contraception. Capable of giving signed informed consent. Exclusion Criteria: History or presence of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk when taking the study intervention, or interfering with the interpretation of data. Participants with allergy/intolerance to a monoclonal antibody or biologic or participants with a previous history of clinically significant multiple or severe drug allergies/intolerance. Current evidence or recent history of an infective illness. A positive pre-study drug/alcohol screen or a history (or suspected history) of alcohol misuse or substance abuse Clinically significant abnormalities. Positive test for severe acute respiratory syndrome coronavirus (SARS-CoV-2) at screening. Recent prior or concurrent clinical study experience.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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
Interventional Model Description: This is a randomized, multicenter, open-label study in healthy adult participants.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants receiving depemokimab via a SSD<br> | Biological: Depemokimab<br>* Depemokimab will be administered via a SSD or autoinjector.<br>|
| Experimental: Participants receiving depemokimab via an autoinjector<br> | Biological: Depemokimab<br>* Depemokimab will be administered via a SSD or autoinjector.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) of depemokimab |  | Up to Week 26 | 
| Area under the concentration-time curve from time zero extrapolated to infinity (AUC[0-inf]) of depemokimab |  | Up to Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration time curve from time zero to time of last observed quantifiable concentration (AUC[0-t]) of depemokimab |  | Up to week 26 | 
| Time to maximum observed plasma concentration (Tmax) of depemokimab |  | Up to Week 26 | 
| Apparent clearance following extravascular administration (CL/F) of depemokimab |  | Up to Week 26 | 
| Apparent volume of distribution following extravascular administration (Vd/F) of depemokimab |  | Up to week 26 | 
| Terminal elimination rate constant (lambda z) of depemokimab |  | Up to Week 26 | 
| Terminal elimination half life (T1/2) of depemokimab |  | Up to Week 26 | 
| Time of last measurable plasma concentrations (Tlast) of depemokimab |  | Up to week 26 | 
| Percentage of AUC(0-inf) due to extrapolation from Tlast to infinity (%AUCex) of depemokimab |  | Up to Week 26 | 
| Number of participants with presence of anti-drug antibody and neutralizing antibody to depemokimab |  | Pre-dose and Weeks 4, 8, 12, 26 post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autoinjector, Depemokimab, Healthy Participants, Safety Syringe Device, Pharmacokinetics