RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-09-26
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06539507

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Confirmed diagnosis of Netherton syndrome (Part 3 only)
  3. * BMI between 18 and 30 kg/m\^2, inclusive (Parts 1 and 2 only)
  4. * 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)
  5. * Agree to follow the protocol contraception requirements from screening until 90 days after the last dose of study drug
  6. * In the opinion of the investigator, expected to adequately comply with all required study procedures and restrictions for the duration of the study
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

BioCryst Pharmaceuticals, Inc.
CONTACT
+1 919 859 1302
clinicaltrials@biocryst.com

Study Locations (Sites)

Investigative site
Indianapolis, Indiana, 46250
United States

Collaborators and Investigators

Sponsor: BioCryst Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-26
Study Completion Date2026-03

Study Record Updates

Study Start Date2024-09-26
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • First-in-human
  • Single ascending dose
  • Multiple ascending dose
  • Pharmacokinetics
  • Placebo control
  • Netherton syndrome

Additional Relevant MeSH Terms

  • Netherton Syndrome