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

ConditionsAge Related Macular Degeneration (ARMD)AMD - Age-Related Macular Degeneration

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 groups

Sponsors and collaborators

Aptabio Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov