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

NCT07330674 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ABF-101-01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Keywords

ABF-101; AMD; NOX

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Maximum Observed Plasma Concentration (Cmax) of ABF-101

  From enrollment up to 12 weeks

• Time to maximal concentration (Tmax) of ABF-101

  From enrollment up to 12 weeks

• The plasma area under the curve (AUC) of ABF-101

  From enrollment up to 12 weeks

• Terminal elimination half-life of ABF-101

  From enrollment up to 12 weeks

Study Arms (3)

Part A (ABF-101 or Placebo)

EXPERIMENTAL

* 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; Drug: Placebo

Part B (ABF-101 or Placebo)

EXPERIMENTAL

* 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; Drug: Placebo

Part C (ABF-101)

EXPERIMENTAL

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

Drug: ABF-101

Interventions

ABF-101 DRUG

orally, QD

Part A (ABF-101 or Placebo); Part B (ABF-101 or Placebo); Part C (ABF-101)

Placebo DRUG

orally, QD

Part A (ABF-101 or Placebo); Part B (ABF-101 or Placebo)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Aptabio Therapeutics, Inc.: lead

Study Sites (1)

Dallas Clinical Research Unit

Dallas, Texas, 75247, United States

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Clinical Center, Clinical Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: January 9, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-01

Locations

US (1)