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

Phase 1

Completed

• Conditions: Asthma
• Interventions: Biological: Depemokimab

• Registration Number: NCT05602025
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-27
• Study First Submitted QC: 2022-10-27
• Study First Posted: 2022-11-01
• Study Start: 2022-12-13
• Primary Completion: 2023-10-23
• Study Completion: 2023-10-23
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants receiving depemokimab via a SSD	Depemokimab	-
Participants receiving depemokimab via an autoinjector	Depemokimab	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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 half life (T1/2) 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
Terminal elimination rate constant (lambda z) 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
Time to maximum observed plasma concentration (Tmax) of depemokimab	Up to Week 26
Time of last measurable plasma concentrations (Tlast) of depemokimab	Up to week 26

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Austin, Texas, United States