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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
ABF-101
Drugorally, QD
Placebo
Drugorally, QD
Treatment groups
68 Participants
are divided into 3 treatment groupsGroup A: Part A (ABF-101 or Placebo)Experimental treatment 2 interventions
Group B: Part B (ABF-101 or Placebo)Experimental treatment 2 interventions
Group C: Part C (ABF-101)Experimental treatment 1 intervention
Trial outcomes
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)
Time frame
From enrollment up to 12 weeksSecondary outcomes
1
Maximum Observed Plasma Concentration (Cmax) of ABF-101
Assessment of the maximum observed plasma concentration
Time frame
From enrollment up to 12 weeks2
Time to maximal concentration (Tmax) of ABF-101
Assessment of time to maximal concentration
Time frame
From enrollment up to 12 weeks3
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 weeks4
Terminal elimination half-life of ABF-101
Assessment of terminal elimination half-life
Time frame
From enrollment up to 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov