NCT05602025

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_1 asthma

Timeline
Completed

Started Dec 2022

Typical duration for phase_1 asthma

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 1, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

December 13, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2023

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

June 16, 2026

Completed
Last Updated

June 16, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

October 27, 2022

Results QC Date

April 8, 2026

Last Update Submit

May 20, 2026

Conditions

Asthma

Keywords

AutoinjectorDepemokimabHealthy ParticipantsSafety Syringe DevicePharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • Maximum Observed Plasma Concentration (Cmax) of Depemokimab

    Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods.

    Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose

  • Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-inf]) of Depemokimab

    Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods.

    Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose

Secondary Outcomes (10)

  • Area Under the Concentration-time Curve From Time Zero to Time of Last Observed Quantifiable Concentration (AUC[0-t]) of Depemokimab

    Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose

  • Time to Maximum Observed Plasma Concentration (Tmax) of Depemokimab

    Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose

  • Apparent Clearance Following Extravascular Administration (CL/F) of Depemokimab

    Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose

  • Apparent Volume of Distribution Following Extravascular Administration (Vd/F) of Depemokimab

    Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose

  • Terminal Elimination Rate Constant (Lambda z) of Depemokimab

    Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose

  • +5 more secondary outcomes

Study Arms (2)

Depemokimab via SSD

EXPERIMENTAL

Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1.

Biological: Depemokimab

Depemokimab via autoinjector

EXPERIMENTAL

Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1.

Biological: Depemokimab

Interventions

DepemokimabBIOLOGICAL

Depemokimab was administered via SSD or autoinjector.

Depemokimab via SSDDepemokimab via autoinjector

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
GSKClinicalSupportHD@gsk.com
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized, multicenter, open-label study in healthy adult participants.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

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 16, 2026

Results First Posted

June 16, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

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 asset(s) with development terminated 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.
More information

Locations

US(3)