A Phase 1 Study of ABF-101 in Single- and Multiple-Ascending Doses
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorAptabio Therapeutics, Inc.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- ABF-101
- Placebo
Treatment groups
68 Participants
are divided into 3 treatment groupsLocations
1Dallas Clinical Research Unit75247, DallasTexas, United States
Sponsors and collaborators
Aptabio Therapeutics, Inc.
Lead sponsor
Source ClinicalTrials.gov