Depemokimab for Asthma

Recruiting at 2 trial locations

Overseen By EU GSK Clinical Trials Call Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: GlaxoSmithKline

Disqualifiers: Cardiovascular, Respiratory, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

140 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests Depemokimab given by a small syringe or autoinjector in healthy people to see how the body handles it, its safety, and if it causes any immune responses.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have any health conditions or are taking medications that could affect the study, you might not be eligible to participate.

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

Healthy adults who weigh at least 50 kg with a BMI of 19-30 can join. They must have no significant allergies, especially to monoclonal antibodies or biologics, and no history of severe drug allergies or substance abuse. Women able to get pregnant should use effective birth control.

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).

Capable of giving signed informed consent.

Exclusion Criteria

You have had serious allergies or intolerances to certain medications or biological treatments in the past.

A positive pre-study drug/alcohol screen or a history (or suspected history) of alcohol misuse or substance abuse.

Clinically significant abnormalities.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of Depemokimab via either a safety syringe device or an autoinjector

1 day

Follow-up

Participants are monitored for safety, tolerability, and immunogenicity after treatment

4 weeks

Treatment Details

Interventions

• Depemokimab

Trial Overview The trial is testing Depemokimab delivered through two different devices: a Safety Syringe Device (SSD) and an autoinjector. It aims to compare how the body absorbs the drug, its safety, tolerability, and potential for immune response.

Participant Groups

Group I: Participants receiving depemokimab via an autoinjector Experimental Treatment 1 Intervention

Group II: Participants receiving depemokimab via a SSD Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

PPD DEVELOPMENT, LP

Industry Sponsor

Trials

167

Recruited

38,000+

David Simmons

PPD DEVELOPMENT, LP

Chief Executive Officer since 2012

BSc in Applied Science from Georgia Institute of Technology

Martina Flammer

PPD DEVELOPMENT, LP

Chief Medical Officer since 2024

MD

PPD

Industry Sponsor

Trials

162

Recruited

36,600+

Dr. Austin Smith

PPD

Chief Medical Officer since 2020

Doctor of Medicine from the Royal College of Surgeons in Ireland

David Simmons

PPD

Chief Executive Officer since 2012

Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University