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Monoclonal Antibodies
Study to Access the Relative Bioavailability of Subcutaneous Dose of Nemolizumab When Administered Via Auto-Injector Versus Dual-Chamber Syringe
Phase 1
Waitlist Available
Research Sponsored by Galderma R&D
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial compares how well a single dose of nemolizumab is absorbed when given using different types of injection devices in healthy adults. Nemolizumab helps reduce inflammation by blocking a specific protein. The goal is to determine which method of administration is more effective.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2022 Phase 3 trial • 274 Patients • NCT045016797%
Headache
5%
Dermatitis atopic
4%
Neurodermatitis
1%
Pemphigoid
1%
Pneumonia
1%
Dermatitis contact
1%
Supraventricular tachycardia
1%
Pneumococcal sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Nemolizumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Nemolizumab With Dual Chamber Syringe (DCS)Experimental Treatment1 Intervention
Participants will receive a 60-mg dose of nemolizumab as a 2 successive subcutaneous injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with Dual Chamber Syringe (DCS).
Group II: Nemolizumab With Auto-Injector (AI)Experimental Treatment1 Intervention
Participants will receive a 60-mg dose of nemolizumab as a 2 successive subcutaneous injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with Auto-Injector (AI).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nemolizumab
2022
Completed Phase 3
~2980
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Galderma R&DLead Sponsor
302 Previous Clinical Trials
60,476 Total Patients Enrolled