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Study to Access the Relative Bioavailability of Subcutaneous Dose of Nemolizumab When Administered Via Auto-Injector Versus Dual-Chamber Syringe

NCT05405985 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2025-01-03

Study results available
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Summary

This study was 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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Nemolizumab

Nemolizumab with Auto-Injector (AI).

DRUG

Nemolizumab

Nemolizumab with Dual-Chamber Syringe (DCS).

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-11
Primary Completion
2022-11-11
Completion
2022-12-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05405985 on ClinicalTrials.gov