Nemolizumab With Auto-Injector (AI) for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Galderma Investigational Site 7023, Lincoln, NE
Healthy Subjects (HS)
Nemolizumab - Drug
Eligibility
18+
All Sexes
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Study Summary

This study is to compare the rate and extent of absorption of a single dose of nemolizumab administered with auto-injectors [AI] (test) versus dual-chamber syringes [DCS] (reference) under controlled conditions in healthy adult subjects.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 11 Secondary · Reporting Duration: From Baseline up to Week 12

Week 12
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)
Change in Area Under Concentration-time Curve From Administration to the Last Observed Concentration Time t (AUC 0-last) of Nemolizumab Administered With Dual-Chamber Syringe (DCS)
Change in Area Under the Concentration-Time Curve Over the Specified Interval (AUC 0-4 weeks) Nemolizumab Administered With Dual-Chamber Syringe (DCS)
Change in Area Under the Concentration-time Curve Over the Specified Interval (AUC 0-4 weeks) of Nemolizumab Administered With Auto-Injector (AI)
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)
Change in Observed Maximum Serum Concentration (Cmax) of Nemolizumab Administered With Dual-Chamber Syringe (DCS)
Change in T max (Time to Achieve C max) of Nemolizumab Administered With Auto-Injector (AI)
Change in T max (Time to Achieve C max) of Nemolizumab Administered With Dual-Chamber Syringe (DCS)
Change in t 1/2 (Half-life) of Nemolizumab Administered With Auto-Injector (AI)
Change in t 1/2 (Half-life) of Nemolizumab When Administered With Dual-Chamber Syringe (DCS)
Number of participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

Trial Safety

Safety Progress

1 of 3

Side Effects for

Nemolizumab (30 mg)
25%Nasopharyngitis
23%Dermatitis atopic
12%Asthma
11%Upper respiratory tract infection
7%Headache
5%Sinusitis
5%Gastroenteritis
5%Folliculitis
5%Dry skin
5%Rhinitis
5%Arthralgia
5%Cough
5%Back pain
5%Abdominal pain
5%Diarrhoea
2%Urinary tract infection
2%Oral herpes
2%Blood creatine phosphokinase increased
2%Pyrexia
2%Cellulitis
2%Nausea
0%Hypertension
0%Asthenia
0%Septic shock
0%Cardio-respiratory arrest
0%Post-traumatic amnestic disorder
0%Pneumonia aspiration
0%Staphylococcal sepsis
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT03100344) in the Nemolizumab (30 mg) ARM group. Side effects include: Nasopharyngitis with 25%, Dermatitis atopic with 23%, Asthma with 12%, Upper respiratory tract infection with 11%, Headache with 7%.

Trial Design

2 Treatment Groups

Nemolizumab With Auto-Injector (AI)
1 of 2
Nemolizumab With Dual Chamber Syringe (DCS)
1 of 2
Experimental Treatment

192 Total Participants · 2 Treatment Groups

Primary Treatment: Nemolizumab With Auto-Injector (AI) · No Placebo Group · Phase 1

Nemolizumab With Auto-Injector (AI)
Drug
Experimental Group · 1 Intervention: Nemolizumab · Intervention Types: Drug
Nemolizumab With Dual Chamber Syringe (DCS)
Drug
Experimental Group · 1 Intervention: Nemolizumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nemolizumab
2019
Completed Phase 3
~520

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline up to week 12
Closest Location: Galderma Investigational Site 7023 · Lincoln, NE
N/AFirst Recorded Clinical Trial
1 TrialsResearching Healthy Subjects (HS)
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing to abstain from all prescription medications during the study, except to treat AEs and contraception, and as permitted under Exclusion 2.
You are eligible for the study if you are between the ages of 18 and 65 years.
You are willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.