ABF-101 single and multiple ascending dose safety test in healthy adults and people with AMD
A Phase 1, Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of Orally Administered ABF- 101
This study will test whether ABF-101 is safe, well tolerated, and how it behaves in the body in healthy adults and in people with age-related macular degeneration.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Aptabio Therapeutics, Inc. Indiv |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT07330674 on ClinicalTrials.gov |
What this trial studies
This Phase 1 program includes three parts: Parts A and B are randomized, double-blind, placebo-controlled cohorts that give single ascending doses (SAD) and multiple ascending doses (MAD) of ABF-101 to healthy adults, while Part C is an open-label cohort of participants with diagnosed AMD. Serial blood sampling in Parts A and B will measure pharmacokinetics and pharmacodynamics, and ocular exams across parts will monitor ocular structure and function. Safety and tolerability are the primary outcomes, with exploratory measures of ocular changes in the AMD cohort. The design uses placebo control and dose escalation to define a safe dose range before further testing in patient populations.
Who should consider this trial
Good fit: Ideal candidates include healthy adults aged 18–50 for the single- and multiple-dose cohorts and adults aged 50 or older with confirmed AMD and adequate vision in the non-study eye for the open-label cohort.
Not a fit: People with significant systemic illness, major ocular abnormalities, active infections, or those seeking immediate therapeutic benefit should not expect direct clinical benefit from this early safety-focused study.
Why it matters
Potential benefit: If ABF-101 is safe and shows promising biological activity, it could become a new treatment option that helps preserve vision in people with AMD.
How similar studies have performed: Targeting NOX pathways and first-in-human agents in this class have shown preclinical promise, but clinical success in AMD is limited and remains early-stage.
Eligibility criteria
Show full inclusion / exclusion 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 alcohol abuse 6. History or presence of drug abuse 7. Positive HBsAg or anti-HCV antibody, or positive results for HIV 8. Blood donation, significant blood loss, or has received a transfusion of any blood or blood products 9. Female participants who are breastfeeding. 10. Female participants must not be pregnant or at risk to become pregnant during the study. Male and female participants must agree to use highly effective contraception 11. Participant who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language barrier or poor mental development Part C 1. Evidence of CNV due to any cause other than AMD 2. History of vitreoretinal surgery 3. Significant ocular diseases that may interfere with the study 4. Significantly impaired renal or hepatic function 5. Use of immunosuppressive drugs 6. Use of any investigational agent or participation in any other clinical trial of an investigational agent or investigational therapy 7. History of severe drug allergies or drug hypersensitivity syndrome 8. Undiagnosed acute illness first observed during screening or between screening and baseline, or severe concurrent medical conditions that, in the investigator's judgment, represent a safety concern. 9. Severe cardiac disease. 10. QTc ≥450 msec or participants with a history of risk factors or other clinically significant ECG abnormalities 11. Stroke or transient ischemic attack 12. Any major surgical procedure w 13. Serious active infection, other serious medical condition or any other condition that would impair the ability of the participant to administer the investigational drug or to adhere to the study protocol requirements 14. Presence of any condition which, in the judgment of the investigator, would prevent the participant from completing the study
Where this trial is running
Dallas, Texas
- Dallas Clinical Research Unit — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Center, Clinical Center
- Email: cd@aptabio.com
- Phone: +82-31-365-3693
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.