ABF-101 for Age-Related Macular Degeneration

Overseen By Clinical Center, Clinical Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Aptabio Therapeutics, Inc.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

68 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-50 with normal vital signs, a BMI of 18.0 to less than 32.0 kg/m2, and weighing between 50-115 kg who don't smoke and agree to avoid caffeine, alcohol, and strenuous activity. It also includes those diagnosed with age-related macular degeneration (AMD).

Inclusion Criteria

I am healthy and between 18 and 50 years old.

Part A and B: Provides written, signed, informed consent prior to selection

Part A and B: BMI of ≥ 18.0 and < 32.0 kg/m2, and body weight between 50 kg and 115 kg, inclusive

Exclusion Criteria

I am currently breastfeeding.

I have had surgery on the retina of my eye.

Part A and B: Any significant abnormalities detected during ocular examination

What Are the Treatments Tested in This Trial?

Interventions

• ABF-101

Trial Overview

The study tests ABF-101's safety and effects on the body compared to a placebo in both healthy participants and those with AMD. The trial will look at how the body processes the drug (pharmacokinetics) and its impact on disease markers (pharmacodynamics).

How Is the Trial Designed?

Group I: Part C (ABF-101) Experimental Treatment 1 Intervention

* Part C will be an open-label study in participants with AMD * Capsule, once daily by mouth

Group II: Part B (ABF-101 or Placebo) Experimental Treatment 2 Interventions

* 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

Group III: Part A (ABF-101 or Placebo) Experimental Treatment 2 Interventions

* Part A (Phase 1a) will be a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy participants. * Capsule, single oral dose

Who Is Running the Clinical Trial?

Aptabio Therapeutics, Inc.

Lead Sponsor

Trials

4

Recruited

520+