A Phase 1, Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of Orally Administered ABF- 101
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:
• 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
Locations
United States
Texas
Dallas Clinical Research Unit
RECRUITING
Dallas
Contact Information
Primary
Clinical Center, Clinical Center
cd@aptabio.com
+82-31-365-3693
Time Frame
Start Date: 2026-02
Estimated Completion Date: 2027-12
Participants
Target number of participants: 68
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Aptabio Therapeutics, Inc.