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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 50 Years

Healthy Volunteers

Accepted

Interventions

• ABF-101 — DRUG
  orally, QD
• Placebo — DRUG
  orally, QD

Study Details

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).

Key Dates

Start date

Feb 28, 2026

Status verified

Jan 2026

Primary completion

Nov 30, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

68 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part A (ABF-101 or Placebo)
  * Part A (Phase 1a) will be a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy participants. * Capsule, single oral dose
• Experimental: Part B (ABF-101 or Placebo)
  * Part B (Phase 1b) will be a randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) study in healthy participants. * Capsule, once daily by mouth
• Experimental: Part C (ABF-101)
  * Part C will be an open-label study in participants with AMD * Capsule, once daily by mouth

Primary Outcome Measure

Number of Participants with treatment-emergent adverse event [ Time Frame: From enrollment up to 12 weeks ]

Central Contacts

• Clinical Center, Clinical Center
  +82-31-365-3693
  [email protected]

Locations (1)

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