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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05602025
• Other study ID #: 214099
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: December 16, 2022
• Est. completion date: January 26, 2024

Study information

• Verified date: May 2023
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: January 26, 2024
• Est. primary completion date: January 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• Depemokimab
Depemokimab will be administered via a SSD or autoinjector.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	PPD

Country where clinical trial is conducted

United States, 

Outcome

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