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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: BioCryst Pharmaceuticals • ClinicalTrials.gov ID: NCT06539507

Registry updated: 2026-08-27
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Description

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.

Interventions

  • BCX17725 (Drug)
    BCX17725 for injection
  • Placebo (Drug)
    Placebo for injection

Eligibility criteria

Key Inclusion Criteria: * Male or non-pregnant, non-lactating female aged 18 to 55 years, inclusive (Parts 1 and 2), 18 to 65 years, inclusive (Part 3), or 12 to 65 years, inclusive (Part 4) * Confirmed diagnosis of Netherton syndrome (Parts 3 and 4) * IGA score of ≥ 3 (Parts 3 and 4) and IASI score of ≥ 16 (Part 4) * BMI between 18 and 30 kg/m\^2, inclusive (Parts 1 and 2) * Estimated glomerular filtration rate (eGFR) of ≥ 90 mL/min/1.73 m\^2 (Parts 1 and 2) or ≥ 60 mL/min/1.73 m\^2 (Part 3) * Agree to follow the protocol contraception requirements from screening until 90 days after the last dose of study drug * In the opinion of the investigator, expected to adequately comply with all required study procedures and restrictions for the duration of the study

Conditions

Netherton Syndrome

Locations

  • 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record