A Phase 1 Study of ABF-101 in Single- and Multiple-Ascending Doses

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Age Related Macular Degeneration (ARMD), AMD - Age-Related Macular Degeneration

In brief

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).

Key facts

Study ID

NCT07330674

Run by

Aptabio Therapeutics, Inc.

People needed

68

Starts

2026-02-01

Expected to finish

2027-12-01

Last updated by the study team

2026-02-06

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Part A and B
• Healthy participants, aged between 18 and 50 years
• Provides written, signed, informed consent prior to selection
• BMI of ≥ 18.0 and < 32.0 kg/m2, and body weight between 50 kg and 115 kg, inclusive.
• Vital signs: normal pulse rate and blood pressure.
• Nonsmoker
• Must be willing to abstain from caffeine and alcohol
• Must be willing to avoid strenuous activity
• Part C
• Confirmed diagnosis of AMD
• Male or female ≥50 years of age
• Adequate visual acuity in the non-study eye

You may not qualify if…

• Part A and B
• Any history or presence of cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, or infectious disease
• Any significant abnormalities detected during ocular examination,
• Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician
• Any drug intake (except paracetamol or contraceptives)
• History or presence alcohol abuse
• History or presence of drug abuse
• Positive HBsAg or anti-HCV antibody, or positive results for HIV
• Blood donation, significant blood loss, or has received a transfusion of any blood or blood products
• Female participants who are breastfeeding.
• 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
• 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
• Evidence of CNV due to any cause other than AMD
• History of vitreoretinal surgery
• Significant ocular diseases that may interfere with the study
• Significantly impaired renal or hepatic function
• Use of immunosuppressive drugs
• Use of any investigational agent or participation in any other clinical trial of an investigational agent or investigational therapy
• History of severe drug allergies or drug hypersensitivity syndrome
• 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.
• Severe cardiac disease.
• QTc ≥450 msec or participants with a history of risk factors or other clinically significant ECG abnormalities
• Stroke or transient ischemic attack
• Any major surgical procedure w

Where it is running

• Dallas Clinical Research Unit — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.