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

NCT05602025 | Completed Phase 1 FDA Drug

• 1 other identifier: 214099
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Asthma

Keywords

Autoinjector; Depemokimab; Healthy Participants; Safety Syringe Device; Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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

Study Arms (2)

Participants receiving depemokimab via a SSD

EXPERIMENTAL

Biological: Depemokimab

Participants receiving depemokimab via an autoinjector

EXPERIMENTAL

Biological: Depemokimab

Interventions

Depemokimab BIOLOGICAL

Depemokimab will be administered via a SSD or autoinjector.

Participants receiving depemokimab via a SSD; Participants receiving depemokimab via an autoinjector

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• PPD Development, LP: collaborator

Study Sites (3)

GSK Investigational Site

Orlando, Florida, 32806, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89113, United States

Location

GSK Investigational Site

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, multicenter, open-label study in healthy adult participants.

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 1, 2022
• Study Start: December 13, 2022
• Primary Completion: October 23, 2023
• Study Completion: October 23, 2023
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

US (3)