Actively Recruiting
A Phase 1 Study of ABF-101 in Single- and Multiple-Ascending Doses
Led by Aptabio Therapeutics, Inc. · Updated on 2026-02-06
68
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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
- Provide written, signed informed consent before joining
- Body mass index (BMI) between 18.0 and less than 32.0 kg/m2
- Body weight between 50 kg and 115 kg
- Normal pulse rate and blood pressure
- Do not smoke
- Willing to avoid caffeine and alcohol
- Willing to avoid strenuous activity
- For Part C: Confirmed diagnosis of age-related macular degeneration (AMD)
- For Part C: Male or female aged 50 years or older
- For Part C: Adequate vision in the non-study eye
You will not qualify if you...
- History or presence of cardiovascular, pulmonary, gastrointestinal, liver, kidney, metabolic, blood, neurological, psychiatric, systemic, or infectious diseases for Parts A and B
- Significant eye abnormalities
- History of drug allergies or hypersensitivity
- Use of any drugs other than paracetamol or contraceptives
- History or presence of alcohol or drug abuse
- Positive tests for hepatitis B, hepatitis C, or HIV
- Recent blood donation, significant blood loss, or blood transfusion
- Breastfeeding women
- Pregnant women or women at risk of pregnancy; must use effective contraception
- Participants unlikely to comply or cooperate during the study
- For Part C: Evidence of choroidal neovascularization not caused by AMD
- History of vitreoretinal surgery
- Significant eye diseases interfering with the study
- Severely impaired kidney or liver function
- Use of immunosuppressive drugs
- Participation in other investigational drug trials
- History of severe drug allergies
- Acute illness or severe medical conditions posing safety concerns
- Severe heart disease
- QTc interval 450 msec or above or significant ECG abnormalities
- History of stroke or transient ischemic attack
- Any major surgery
- Serious infections or medical conditions impairing study adherence
- Any condition preventing study completion as judged by the investigator
AI-Screening
AI-Powered Screening
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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
CONTACT
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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