A Phase 1 Study of ABF-101 in Single- and Multiple-Ascending Doses
Trial Parameters
Brief 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).
Eligibility Criteria
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. Any history or presence of cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, or infectious disease 2. Any significant abnormalities detected during ocular examination, 3. Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician 4. Any drug intake (except paracetamol or contraceptives) 5. History or presence a