Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06539507 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 12 sitesv14
  2. Site details revised at 1 of 12 sitesv13
  3. Site details revised at 2 of 12 sitesv12
  4. Site contacts updated at 1 of 12 sitesv11
  5. Site details revised at 1 of 12 sitesv10
Show 8 earlier versionsHide 8 earlier versions
  1. Site details revised at 1 of 12 sitesv9
  2. Site details revised at 1 of 12 sitesv8
  3. Study sites: 5 to 12v7
  4. Study sites: 4 to 5v6
  5. Primary completion date: Mar 2026 to Oct 2026v5 Show 8 more changesShow less
    • Primary endpoints: 1 to 2
    • Enrollment target: 66 to 78
    • Study sites: 3 to 4
    • Study completion date: Mar 2026 to Dec 2026
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: 5 to 9
    • Study description expanded, about 27 words
    • Study arms: 5 to 6
  6. Study sites: 2 to 3v4
  7. Primary and study completion dates: Jul 2025 to Mar 2026
    • Enrollment target: 72 to 66
    • Study sites: 1 to 2
    v3
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2024 to Sep 26, 2024
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06539507
Lead Sponsor BioCryst Pharmaceuticals
Conditions
(from sponsor)		 Netherton Syndrome
Related terms Netherton Syndrome
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov