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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
68
Dallas Clinical Research Unit
Dallas, Texas, United States
RECRUITINGNumber 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)
Time frame: From enrollment up to 12 weeks
Maximum Observed Plasma Concentration (Cmax) of ABF-101
Assessment of the maximum observed plasma concentration
Time frame: From enrollment up to 12 weeks
Time to maximal concentration (Tmax) of ABF-101
Assessment of time to maximal concentration
Time frame: From enrollment up to 12 weeks
The plasma area under the curve (AUC) of ABF-101
Assessment of the plasma area under the curve
Time frame: From enrollment up to 12 weeks
Terminal elimination half-life of ABF-101
Assessment of terminal elimination half-life
Time frame: From enrollment up to 12 weeks
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