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Monoclonal Antibodies

Nemolizumab for Healthy Subjects

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 from baseline up to week 12
Awards & highlights

Study Summary

This trial is testing if a new way of taking a medication is as effective as the current method.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Area under Concentration-time Curve Extrapolated to Infinity (AUC 0-inf) of Nemolizumab Administered With AI (Auto-Injector)
Change in Area under Concentration-time Curve Extrapolated to Infinity (AUC 0-inf) of Nemolizumab Administered With Dual-Chamber Syringe (DCS)
Change in Observed Maximum Serum Concentration (Cmax) of Nemolizumab Administered With Auto-Injector (AI)
+1 more
Secondary outcome measures
Assessment of the Immunogenicity (anti-drug antibodies, ADA) of Nemolizumab Administered With Auto-Injector (AI)
Assessment of the Immunogenicity (anti-drug antibodies, ADA) of Nemolizumab Administered With Dual-Chamber Syringe (DCS)
Change in Area Under Concentration-time Curve From Administration to the Last Observed Concentration Time t (AUC 0-last) of Nemolizumab Administered With Auto-Injector (AI)
+8 more

Side effects data

From 2018 Phase 2 trial • 226 Patients • NCT03100344
33%
Nasopharyngitis
20%
Dermatitis atopic
13%
Headache
7%
Nausea
7%
Sinusitis
7%
Upper respiratory tract infection
5%
Diarrhoea
5%
Urinary tract infection
4%
Blood creatine phosphokinase increased
4%
Oral herpes
4%
Asthma
2%
Cough
2%
Back pain
2%
Arthralgia
2%
Cardio-respiratory arrest
2%
Pyrexia
2%
Abdominal pain
2%
Staphylococcal sepsis
2%
Asthenia
2%
Post-traumatic amnestic disorder
2%
Pneumonia aspiration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nemolizumab (10 mg)
Nemolizumab (90 mg)
Nemolizumab (30 mg)
Placebo

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
2021
Completed Phase 3
~2750

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
299 Previous Clinical Trials
60,228 Total Patients Enrolled

Frequently Asked Questions

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

Does the age criterion of this experiment include minors?

"This medical trial calls for individuals aged 18-65 to participate. For those younger than 18 or older than 65, there are 50 and 372 trials respectively that they may be eligible for."

Answered by AI

Do I meet the requirements for enrollment in this research project?

"This medical trial seeks 192 individuals, aged between 18 and 65 who are healthy subjects (HS) for examination. Body weight must be at least 45kg with a body mass index of 18-30kg/m^2 measured during the screening and baseline visits. Participants should also display no signs of ill health based on physical examination or clinical laboratory tests. Any women capable of becoming pregnant need to agree to abstinence throughout the study and 12 weeks after drug injection or use an adequate method of contraception approved by this research team; males do not require any form of birth control but may not donate sperm during this period either. Women incapable of conceiving have"

Answered by AI

To what extent does Nemolizumab pose a risk to patient health?

"There is only a limited amount of data supporting the safety and effectiveness of Nemolizumab, thus it has been scored as a 1."

Answered by AI

Are any vacancies available in this medical trial?

"According to clinicaltrials.gov, this research project is currently not recruiting participants; the original posting was on August 11th 2022 and it has been updated most recently on October 10th 2022. Nevertheless, there are 840 other trials enrolling patients at present."

Answered by AI

Who else is applying?

What state do they live in?
Nebraska
Arizona
How old are they?
18 - 65
What site did they apply to?
Galderma Investigational Site 7024
Galderma Investigational Site 7023
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Average response time
  • < 2 Days
Most responsive sites:
  1. Galderma Investigational Site 7024: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Study to Access the Relative Bioavailability of Subcutaneous Dose of Nemolizumab When Administered Via Auto-Injector Versus Dual-Chamber Syringe
2022. "Study to Access the Relative Bioavailability of Subcutaneous Dose of Nemolizumab When Administered Via Auto-Injector Versus Dual-Chamber Syringe". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05405985.
~72 spots leftby Apr 2025
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