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RECRUITING
NCT06539507
PHASE1

A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725

Sponsor: BioCryst Pharmaceuticals

View on ClinicalTrials.gov

Summary

This is a first-in-human, Phase 1/1b, 4-part study that includes the evaluation of safety, tolerability, pharmacokinetics (PK), and immunogenicity of BCX17725 when administered via single and multiple doses in healthy adult participants (Parts 1 and 2), and multiple doses in adult participants with Netherton syndrome (Part 3). In Part 4, the effectiveness, safety, and tolerability of BCX17725 when administered via multiple IV and/or SC doses through 12 weeks will be evaluated in adult and adolescent participants with Netherton syndrome.

Official title: A Phase 1/1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of BCX17725 in Healthy Participants and Multiple Doses of BCX17725 in Participants With Netherton Syndrome

Key Details

Gender

All

Age Range

12 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2024-09-26

Completion Date

2026-12

Last Updated

2026-03-31

Healthy Volunteers

Yes

Interventions

DRUG

BCX17725

BCX17725 for injection

DRUG

Placebo

Placebo for injection

Locations (12)

Stanford University School of Medicine

Palo Alto, California, United States

Therapeutics Clinical Research

San Diego, California, United States

Yale Center for Clinical Investigation

New Haven, Connecticut, United States

Northwestern Dermatology CTU

Chicago, Illinois, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Westmead Hospital - Department of Dermatology

Sydney, New South Wales, Australia

Nucleus Network

Brisbane, Queensland, Australia

Veracity Clinical Research

Brisbane, Queensland, Australia

Hôpital Saint-Louis

Paris, France

Universitätsklinikum Heidelberg

Heidelberg, Germany

Maastricht Universitair Medisch Centrum (MUMC+)

Maastricht, Netherlands

Erasmus Universitair Medisch Centrum (EMC)

Rotterdam, Netherlands