RecruitingPhase 1NCT07330674

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

A Phase 1, Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of Orally Administered ABF- 101

Sponsor

Aptabio Therapeutics, Inc.

Enrollment

68 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria12

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

Exclusion Criteria27

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
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
Presence of any condition which, in the judgment of the investigator, would prevent the participant from completing the study