NCT07330674

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Aptabio Therapeutics, Inc. · Individual
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1 study to evaluate the safety, tolerability, PK, and PD of ABF-101 in healthy participants and participants with age-related macular degeneration (AMD).

Detailed description

Part A will be a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy participants. Part B will be a randomized, double-blind, placebo-controlled, multiple ascending doses (MAD) study in healthy participants. Part C will be an open-label study in participants with AMD. For Part A and B, serial blood samples will be collected to assess the PK of ABF-101. Ocular examinations will be conducted to evaluate changes in ocular characteristics and function.

Conditions

• Age Related Macular Degeneration (ARMD)
• AMD - Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	ABF-101	orally, QD
DRUG	Placebo	orally, QD

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-11-01
• Completion: 2027-12-01
• First posted: 2026-01-09
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study