Aptabio Therapeutics, Inc.
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).
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.
Inclusion Criteria: * Part A and B 1. Healthy participants, aged between 18 and 50 years 2. Provides written, signed, informed consent prior to selection 3. BMI of ≥ 18.0 and \< 32.0 kg/m2, and body weight between 50 kg and 115 kg, inclusive. 4. Vital signs: normal pulse rate and blood pressure. 5. Nonsmoker 6. Must be willing to abstain from caffeine and alcohol 7. Must be willing to avoid strenuous activity * Part C 1. Confirmed diagnosis of AMD 2. Male or female ≥50 years of age 3. Adequate visual acuity in the non-study eye Exclusion Criteria: * Part A and B 1.…
orally, QD
orally, QD
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