Recruiting
Phase 1

ABF-101

Sponsor:

Aptabio Therapeutics, Inc.

Code:

NCT07330674

Conditions

Age Related Macular Degeneration (ARMD)

AMD - Age-Related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

ABF-101

Placebo

Study Details

Brief 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).

Conditions

Age Related Macular Degeneration (ARMD)

AMD - Age-Related Macular Degeneration

Study ID

NCT07330674

Start date

Feb, 2026

Status verified date

Jan, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A (ABF-101 or Placebo)

  • Part A (Phase 1a) will be a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy participants.
  • Capsule, single oral dose

experimental: Part B (ABF-101 or Placebo)

  • Part B (Phase 1b) will be a randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) study in healthy participants.
  • Capsule, once daily by mouth

experimental: Part C (ABF-101)

  • Part C will be an open-label study in participants with AMD
  • Capsule, once daily by mouth

Interventions

ABF-101

orally, QD

Placebo

orally, QD

Primary outcome measure

  • Number of Participants with treatment-emergent adverse event [ Time Frame: From enrollment up to 12 weeks ]

Central Contacts and Locations

Central contacts

Clinical Center, Clinical Center

+82-31-365-3693cd@aptabio.com

Locations

Dallas Clinical Research Unit

Recruiting

Dallas, Texas, United States, 75247

More Information

Sponsor

Aptabio Therapeutics, Inc.

Last update posted

Feb 6, 2026

Last verified

Jan, 2026

Keywords

  • ABF-101
  • AMD
  • NOX

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Aptabio Therapeutics, Inc. on 2026-02-06.