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Monoclonal Antibodies

Depemokimab for Asthma

Phase 1
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose and weeks 4, 8, 12, 26 post dose
Awards & highlights

Study Summary

This trial compares how safe and effective a drug is when given via a needleless device or an autoinjector.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects are not detailed but may include reactions typical for monoclonal antibody treatments such as injection site reactions, allergic responses, fatigue, headache, or flu-like symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose and weeks 4, 8, 12, 26 post dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and weeks 4, 8, 12, 26 post dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the concentration-time curve from time zero extrapolated to infinity (AUC[0-inf]) of depemokimab
Maximum observed plasma concentration (Cmax) of depemokimab
Secondary outcome measures
Apparent clearance following extravascular administration (CL/F) of depemokimab
Apparent volume of distribution following extravascular administration (Vd/F) of depemokimab
Area under the concentration time curve from time zero to time of last observed quantifiable concentration (AUC[0-t]) of depemokimab
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Participants receiving depemokimab via an autoinjectorExperimental Treatment1 Intervention
Group II: Participants receiving depemokimab via a SSDExperimental Treatment1 Intervention

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,764 Previous Clinical Trials
8,104,709 Total Patients Enrolled
296 Trials studying Asthma
448,218 Patients Enrolled for Asthma
PPDIndustry Sponsor
161 Previous Clinical Trials
36,849 Total Patients Enrolled
4 Trials studying Asthma
1,527 Patients Enrolled for Asthma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,596 Previous Clinical Trials
6,144,201 Total Patients Enrolled
229 Trials studying Asthma
402,104 Patients Enrolled for Asthma

Media Library

Depemokimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05602025 — Phase 1
Asthma Research Study Groups: Participants receiving depemokimab via a SSD, Participants receiving depemokimab via an autoinjector
Asthma Clinical Trial 2023: Depemokimab Highlights & Side Effects. Trial Name: NCT05602025 — Phase 1
Depemokimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05602025 — Phase 1
Asthma Patient Testimony for trial: Trial Name: NCT05602025 — Phase 1
~58 spots leftby May 2025
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