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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
4,751 Previous Clinical Trials
8,067,332 Total Patients Enrolled
294 Trials studying Asthma
415,287 Patients Enrolled for Asthma
PPDIndustry Sponsor
159 Previous Clinical Trials
36,775 Total Patients Enrolled
4 Trials studying Asthma
1,527 Patients Enrolled for Asthma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,790 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age limitation for this experiment include seniors above seventy-five years old?

"Individuals aged 18 to 50 are eligible for this medical trial. There are 117 other studies targeting minors and 193 specifically aimed at seniors."

Answered by AI

What potential risk factors exist for individuals taking depemokimab via a subcutaneous delivery system?

"The safety of depemokimab administered using a SSD has only been tested in limited contexts, so it received an assessment score of 1."

Answered by AI

What is the current enrollment for this clinical trial?

"Affirmative. According to clinicaltrials.gov, this trial was first announced on December 16th 2022 and is currently recruiting patients. The study requires a total of 140 participants from 3 different sites."

Answered by AI

Are applications for participants currently being accepted by this research?

"That is correct. According to clinicaltrials.gov, this medical study, which began on December 16th 2022, currently has a call for volunteers. A total of 140 patients must be recruited from 3 distinct research centres."

Answered by AI

Are there certain prerequisites for participating in this experiment?

"This research initiative seeks to recruit 140 participants, aged 18-50 and suffering from asthma. Other criteria include being medically healthy as confirmed by lab tests, physical exams, vital signs, EKG's etc., having a minimum body weight of 50 kilograms (110 Ibs) and BMI between 19-30 kg/m^2 , female patients of childbearing age must use highly effective contraception methods, and all study subjects must be willing to provide informed consent."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

My emergency inhaler is not really cutting it for me anymore and I am looking into alternative methods to get my chronic asthma under control...
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered With a Safety Syringe Device (SSD) or an Autoinjector in Healthy Adult Participants
2022. "A Study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered With a Safety Syringe Device (SSD) or an Autoinjector in Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05602025.
~60 spots leftby Apr 2025
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