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A Study to Evaluate the Safety of AB-1003 (Previously LION-101) in Subjects With Genetic Confirmation of LGMD2I/R9 (Part1)

StatusActive, Not Recruiting
PhasePhase 1/2
SponsorAskBio Inc
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 10% 10 → 9 participants
See other at-risk trials from AskBio Inc

Record History

  1. Enrollment closed, study ongoing Enrollment reduced: 10 → 9 participants · Interventions: AB-1003 dose level 1 (Genetic), AB-1003 dose level 2 (Genetic), Placebo (Other) to AB-1003 dose level 1 (Genetic), AB-1003 dose level 2 (Genetic), Placebo (Drug) · Site details revised at 6 of 6 sitesv15 Show 3 more changesShow less
    • Enrollment reduced: 10 → 9 participants
    • Interventions: AB-1003 dose level 1 (Genetic), AB-1003 dose level 2 (Genetic), Placebo (Other) to AB-1003 dose level 1 (Genetic), AB-1003 dose level 2 (Genetic), Placebo (Drug)
    • Site details revised at 6 of 6 sites
  2. Eligibility criteria shortened, about 10 wordsv14 See this version in full on ClinicalTrials.gov ↗
  3. Completion date: Dec 2028 to Dec 2032v13
  4. Eligibility criteria revised Site contacts updated at 1 of 6 sitesv12 Show 1 more changeShow less
    • Site contacts updated at 1 of 6 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Start date: Mar 12, 2023 to May 15, 2023 Eligibility criteria expanded, about 16 wordsv11 Show 1 more changeShow less
    • Eligibility criteria expanded, about 16 words

    See this version in full on ClinicalTrials.gov ↗

Show 9 earlier versionsHide 9 earlier versions
  1. Site contacts updated at 2 of 6 sitesv10
  2. Study sites: 5 to 6 Interventions: LION-101 dose level 1 (Genetic), LION-101 dose level 2 (Genetic), Placebo (Other) to AB-1003 dose level 1 (Genetic), AB-1003 dose level 2 (Genetic), Placebo (Other) · Eligibility criteria shortened, about 2 words · Study title expanded, about 2 wordsv9 Show 3 more changesShow less
    • Interventions: LION-101 dose level 1 (Genetic), LION-101 dose level 2 (Genetic), Placebo (Other) to AB-1003 dose level 1 (Genetic), AB-1003 dose level 2 (Genetic), Placebo (Other)
    • Eligibility criteria shortened, about 2 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 3 to 5v8
  4. Site contacts updated at 1 of 3 sitesv7
  5. Study sites: 2 to 3v6
  6. Study sites: 1 to 2v5
  7. Site contact updatedv4
  8. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of May 2022 to Mar 12, 2023 · Study sites expanded, about 3 wordsv3 Show 2 more changesShow less
    • Start date changed from estimate of May 2022 to Mar 12, 2023
    • Study sites expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  9. Study title shortened, about 4 wordsv2 See this version in full on ClinicalTrials.gov ↗
  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.
AskBio Inc
9 trials monitored
See 3 trials at risk
The purpose of this study is to evaluate the safety and tolerability of a single intravenous infusion of AB-1003 in adults diagnosed with limb girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). Participants will be treated in sequential, dose-level cohorts. (Part 1)
Trial Details
NCT Number NCT05230459
Lead Sponsor AskBio Inc
Conditions Limb Girdle Muscular Dystrophy, Limb-Girdle Muscular Dystrophy Type 2, LGMD2I, Muscular Dystrophy, LGMD2, LGMD, FKRP, FKRP Mutation +1 more
Enrollment 9 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov