RecruitingPhase 1NCT06539507

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

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

Sponsor

BioCryst Pharmaceuticals

Enrollment

78 participants

Start Date

Sep 26, 2024

Study Type

INTERVENTIONAL

Conditions

Netherton Syndrome

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.

Eligibility

Min Age: 12 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called BCX17725 and a drug called Placebo for people with netherton syndrome. The study is currently recruiting participants at 12 locations. People eligible for this study include aged 12 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBCX17725

BCX17725 for injection

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06539507

Related Trials

Open Label, Safety and Efficacy Study of QRX003 Lotion in Subjects With Netherton Syndrome

NCT057890564 locations