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RecruitingAccepts healthy volunteersPhase 1

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

BioCryst Pharmaceuticals · NCT06539507

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 12–65 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
78
US sites recruiting
5
Study start
September 26, 2024
Record last updated
August 27, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: BCX17725; Placebo

Conditions: Netherton Syndrome

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Stanford University School of Medicine

    Palo Alto, CA 94304

    Site contact: Chaw-Ning Lee · 650-497-7230 · cnlee06@stanford.edu

  • Therapeutics Clinical Research

    San Diego, CA 92123

    Site contact: Hector Bailon · 858-571-6800 · hbailon@therapeuticsresearch.com

  • Yale Center for Clinical Investigation

    New Haven, CT 06519

    Site contact: Nicole Olszewski · 203-785-5505 · nicole.olszewski@yale.edu

  • Northwestern Dermatology CTU

    Chicago, IL 60611

    Site contact: 312-503-5944 · NUderm-research@northwestern.edu

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, IN 46250

    Site contact: Joannie Prusa · 317-516-5030 · jprusa@ecommunity.com

Study contacts (from the official record)

  • BioCryst Pharmaceuticals, Inc. · +1 919 859 1302 · clinicaltrials@biocryst.com
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A Study of the Safety, Tolerability, Pharmacokinetics, and… (NCT06539507) | Bored Studies