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First-in-Human, Dose Escalation Trial of AXV-101 in BBS1-Related Retinal Degeneration

Study acronym: AXIS
StatusRecruiting
PhaseEarly Phase 1
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Recruitment opened
    • Start date changed from estimate of May 2026 to Jun 26, 2026
    • Site details revised
    v4
  2. Start date: Feb 23, 2026 to May 2026v3
  3. Study site revisedv2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this first in human study is to evaluate the preliminary safety and tolerability of AXV-101 in participants with BBS1. The main questions it aims to answer are: * Is AXV-101 safe and tolerable to use in participants with BBS1? * To determine the therapeutic dose of AXV-101 in participants with BBS1 * To investigate the concentration of AXV-101 in blood, urine and tears (both eyes) Participants will undergo comprehensive ophthalmic assessments to evaluate functional and structural changes from baseline to one year in the treated eye compared with the untreated eye. Additional evaluations will include blood, urine, and tear testing for safety and pharmacokinetics, and quality of life questionnaires completed by both participants and caregivers. Safety will also be assessed by monitoring the frequency and severity of adverse events, including serious adverse events, through medical history, physical examinations, and laboratory testing.
Trial Details
NCT Number NCT07269665
Lead Sponsor Axovia Therapeutics
Conditions
(from sponsor)		 Bardet-Biedl Syndrome 1, Retinal Degeneration
Related terms Bardet-Biedl syndrome 1, Retinal Degeneration
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov