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A Phase 1, Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of Orally Administered ABF- 101

Trial Profile

A Phase 1, Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of Orally Administered ABF- 101

Status: Suspended
Phase of Trial: Phase I

Latest Information Update: 16 Mar 2026

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At a glance

  • Drugs ABF 101 (Primary)
  • Indications Age-related myocardial degeneration; Macular degeneration
  • Focus Adverse reactions
  • Sponsors AptaBio Therapeutics

Most Recent Events

  • 24 Feb 2026 According to AptaBio Therapeutics media release, FDA requested a re-verification of the reliability of the data provided by the facility and has temporarily suspended the clinical trial until the supplementary measures are completed.The company plans to promptly submit supplementary data and normalize clinical trials as soon as possible.
  • 24 Feb 2026 Status changed from recruiting to suspended.
  • 24 Feb 2026 According to AptaBio Therapeutics media release, company announced that it had received a Clinical Hold notice from the U.S. Food and Drug Administration (FDA) regarding the U.S. Phase 1 clinical trial of ABF-101. The primary reason for this clinical hold is administrative and procedural issues at the nonclinical GLP (Good Laboratory Practice) facility, unrelated to drug mechanism or safety issues.

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