Actively Recruiting
A Phase 1, Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of Orally Administered ABF-101
Led by Aptabio Therapeutics, Inc. · Updated on 2026-02-06
68
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ABF-101 in a Phase 1 study to assess its safety, tolerability, and how the body processes the drug in healthy adults and people with age-related macular degeneration (AMD). The study aims to understand the effects of ABF-101 on participants' eye health and how the drug behaves in the body through blood and ocular tests. The study has three parts: Part A involves healthy participants receiving a single ascending oral dose of ABF-101 or placebo in a randomized, double-blind manner. Part B includes healthy participants taking multiple ascending oral doses daily, also randomized and blinded. Part C is an open-label study where participants with AMD receive daily oral doses of ABF-101 without placebo. Participants will undergo blood sampling to measure drug levels and eye examinations to monitor changes in eye function and structure. The study also tracks any side effects from enrollment up to 12 weeks. Participant involvement includes adherence to dosing and monitoring schedules, with safety and drug activity closely observed throughout the study period.
CONDITIONS
Brief Title
A Phase 1 Study of ABF-101 in Single- and Multiple-Ascending Doses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy participants aged 18 to 50 years for Parts A and B
- Provides signed informed consent before selection
- Body mass index (BMI) between 18.0 and less than 32.0 kg/m2
- Body weight between 50 kg and 115 kg inclusive
- Normal pulse rate and blood pressure
- Nonsmoker
- Willingness to abstain from caffeine and alcohol
- Willingness to avoid strenuous activity
- Participants aged 50 years or older with confirmed diagnosis of age-related macular degeneration for Part C
- Adequate visual acuity in the non-study eye for Part C
You will not qualify if you...
- History or presence of cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, or infectious diseases for Parts A and B
- Significant abnormalities detected during ocular examination for Parts A and B
- History of drug hypersensitivity or allergic disease treated by a physician for Parts A and B
- Use of any drugs except paracetamol or contraceptives for Parts A and B
- History or presence of alcohol or drug abuse for Parts A and B
- Positive tests for hepatitis B, hepatitis C, or HIV for Parts A and B
- Recent blood donation, significant blood loss, or blood transfusion for Parts A and B
- Female participants breastfeeding or pregnant, or at risk of pregnancy without highly effective contraception for Parts A and B
- Non-compliance or inability to cooperate due to language or mental development issues for Parts A and B
- Evidence of choroidal neovascularization from causes other than AMD for Part C
- History of vitreoretinal surgery for Part C
- Significant ocular diseases interfering with the study for Part C
- Significantly impaired kidney or liver function for Part C
- Use of immunosuppressive drugs for Part C
- Participation in another investigational drug trial for Part C
- History of severe drug allergies or hypersensitivity syndrome for Part C
- Acute or severe concurrent medical conditions posing safety concerns for Part C
- Severe cardiac disease or clinically significant ECG abnormalities for Part C
- Stroke or transient ischemic attack for Part C
- Major surgical procedures recently for Part C
- Serious active infections or other conditions impairing study participation for Part C
- Any condition likely to prevent study completion as judged by investigator for Part C
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive ABF-101 or placebo orally, either as a single ascending dose or multiple ascending doses, to assess safety, tolerability, and pharmacokinetics.
Multiple visits during treatment for dosing and assessments
Trial Site Locations
Total: 1 location
1
Dallas Clinical Research Unit
Dallas, Texas, United States, 75247
Actively Recruiting
Research Team
C
Clinical Center, Clinical Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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