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

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).

Study Overview

• Status: Recruiting
• Conditions: Age Related Macular Degeneration (ARMD); AMD - Age-Related Macular Degeneration
• Intervention / Treatment: Drug: ABF-101; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Center, Clinical Center; Phone Number: +82-31-365-3693; Email: cd@aptabio.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Recruiting
      • Dallas Clinical Research Unit
      • Contact: Monica Lopez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: ABF-101; orally, QD; Drug: Placebo; orally, QD
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	Drug: ABF-101; orally, QD; Drug: Placebo; orally, QD
Experimental: Part C (ABF-101); Part C will be an open-label study in participants with AMD; Capsule, once daily by mouth	Drug: ABF-101; orally, QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with treatment-emergent adverse event	To investigate the safety and tolerability of single ascending dose of ABF-101orally administered in healthy participants (Part A and B) and in AMD (Part C)	From enrollment up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of ABF-101	Assessment of the maximum observed plasma concentration	From enrollment up to 12 weeks
The plasma area under the curve (AUC) of ABF-101	Assessment of the plasma area under the curve	From enrollment up to 12 weeks
Terminal elimination half-life of ABF-101	Assessment of terminal elimination half-life	From enrollment up to 12 weeks
Time to maximal concentration (Tmax) of ABF-101	Assessment of time to maximal concentration	From enrollment up to 12 weeks

Collaborators and Investigators

• Sponsor: Aptabio Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: AMD; NOX; ABF-101
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration
• Other Study ID Numbers: ABF-101-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No