RECRUITING

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

Description

This is a first-in-human, Phase 1/1b, 3-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 participants with Netherton Syndrome (Part 3).

Conditions

Netherton Syndrome
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Related Conditions:

Netherton Syndrome

Study Overview

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Study Details

Study overview

This is a first-in-human, Phase 1/1b, 3-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 participants with Netherton Syndrome (Part 3).

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

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

Condition
Netherton Syndrome
Intervention / Treatment

-

Contacts and Locations

Indianapolis

Investigative site, Indianapolis, Indiana, United States, 46250

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male or non-pregnant, non-lactating female aged 18 to 55 years, inclusive (Parts 1 and 2) or aged 18 to 65 years, inclusive (Part 3)
  • * Confirmed diagnosis of Netherton syndrome (Part 3 only)
  • * BMI between 18 and 30 kg/m\^2, inclusive (Parts 1 and 2 only)
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

BioCryst Pharmaceuticals,

Study Record Dates

2026-03