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Phase 1
Age: 18Years - 50Years
All Genders
Healthy Volunteers
ID07330674

Phase 1 Study to Evaluate Safety and Effects of ABF-101 by Oral Dosing in Healthy Adults and Adults with Age-Related Macular Degeneration

Led by Aptabio Therapeutics, Inc. · Updated on 2026-02-06

68

Participants Needed

1

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating ABF-101 in a Phase 1 study to assess its safety, tolerability, and how the body processes the drug in healthy adults and people with age-related macular degeneration AMD. The study aims to understand the effects of ABF-101 on participants eye health and how the drug behaves in the body through blood and ocular tests. The study has three parts Part A involves healthy participants receiving a single ascending oral dose of ABF-101 or placebo in a randomized, double-blind manner. Part B includes healthy participants taking multiple ascending oral doses daily, also randomized and blinded. Part C is an open-label study where participants with AMD receive daily oral doses of ABF-101 without placebo. Participants will undergo blood sampling to measure drug levels and eye examinations to monitor changes in eye function and structure. The study also tracks any side effects from enrollment up to 12 weeks. Participant involvement includes adherence to dosing and monitoring schedules, with safety and drug activity closely observed throughout the study period.

CONDITIONS

Brief Title

A Phase 1 Study of ABF-101 in Single- and Multiple-Ascending Doses

Research Team

C

Clinical Center, Clinical Center

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