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

NCT ID: NCT07330674

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2027-12-31

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).

Detailed Description

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

Part B will be a randomized, double-blind, placebo-controlled, multiple ascending doses (MAD) study in healthy participants.

Part C will be an open-label study in participants with AMD. For Part A and B, serial blood samples will be collected to assess the PK of ABF-101. Ocular examinations will be conducted to evaluate changes in ocular characteristics and function.

Conditions

Age Related Macular Degeneration (ARMD); AMD - Age-Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

ABF-101

Intervention Type: DRUG

orally, QD

Placebo

Intervention Type: DRUG

orally, QD

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

Group Type: EXPERIMENTAL

ABF-101

Intervention Type: DRUG

orally, QD

Placebo

Intervention Type: DRUG

orally, QD

Part C (ABF-101)

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

Group Type: EXPERIMENTAL

ABF-101

Intervention Type: DRUG

orally, QD

Interventions

ABF-101

orally, QD

Intervention Type: DRUG

Placebo

orally, QD

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aptabio Therapeutics, Inc.

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dallas Clinical Research Unit

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Center, Clinical Center

Role: CONTACT

cd@aptabio.com

+82-31-365-3693

Facility Contacts

Monica Lopez

Role: primary

Other Identifiers

ABF-101-01

Identifier Type: -

Identifier Source: org_study_id