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

RecruitingPhase 1Ages 12 Years - 65 YearsAllBioCryst Pharmaceuticals
NCT06539507 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • BCX17725
  • Placebo
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Where

12 sites
Stanford University School of Medicine
Palo Alto, United States
Therapeutics Clinical Research
San Diego, United States
Yale Center for Clinical Investigation
New Haven, United States
Northwestern Dermatology CTU
Chicago, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, United States
Westmead Hospital - Department of Dermatology
Sydney, Australia
Nucleus Network
Brisbane, Australia
Veracity Clinical Research
Brisbane, Australia

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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