Age Related Macular Degeneration (ARMD), AMD - Age-Related Macular Degeneration
Conditions
Keywords
ABF-101, AMD, NOX
Brief 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).
Detailed description
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.
Interventions
DRUGABF-101
orally, QD
DRUGPlacebo
orally, QD
Sponsors
Aptabio Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Part A and B 1. Healthy participants, aged between 18 and 50 years 2. Provides written, signed, informed consent prior to selection 3. BMI of ≥ 18.0 and \< 32.0 kg/m2, and body weight between 50 kg and 115 kg, inclusive. 4. Vital signs: normal pulse rate and blood pressure. 5. Nonsmoker 6. Must be willing to abstain from caffeine and alcohol 7. Must be willing to avoid strenuous activity * Part C 1. Confirmed diagnosis of AMD 2. Male or female ≥50 years of age 3. Adequate visual acuity in the non-study eye
Exclusion criteria
* Part A and B 1. Any history or presence of cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, or infectious disease 2. Any significant abnormalities detected during ocular examination, 3. Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician 4. Any drug intake (except paracetamol or contraceptives) 5. History or presence alcohol abuse 6. History or presence of drug abuse 7. Positive HBsAg or anti-HCV antibody, or positive results for HIV 8. Blood donation, significant blood loss, or has received a transfusion of any blood or blood products 9. Female participants who are breastfeeding. 10. Female participants must not be pregnant or at risk to become pregnant during the study. Male and female participants must agree to use highly effective contraception 11. Participant who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language barrier or poor mental development Part C 1. Evidence of CNV due to any cause other than AMD 2. History of vitreoretinal surgery 3. Significant ocular diseases that may interfere with the study 4. Significantly impaired renal or hepatic function 5. Use of immunosuppressive drugs 6. Use of any investigational agent or participation in any other clinical trial of an investigational agent or investigational therapy 7. History of severe drug allergies or drug hypersensitivity syndrome 8. Undiagnosed acute illness first observed during screening or between screening and baseline, or severe concurrent medical conditions that, in the investigator's judgment, represent a safety concern. 9. Severe cardiac disease. 10. QTc ≥450 msec or participants with a history of risk factors or other clinically significant ECG abnormalities 11. Stroke or transient ischemic attack 12. Any major surgical procedure w 13. Serious active infection, other serious medical condition or any other condition that would impair the ability of the participant to administer the investigational drug or to adhere to the study protocol requirements 14. Presence of any condition which, in the judgment of the investigator, would prevent the participant from completing the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with treatment-emergent adverse event | From enrollment up to 12 weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of ABF-101 | From enrollment up to 12 weeks | Assessment of the maximum observed plasma concentration |
| Time to maximal concentration (Tmax) of ABF-101 | From enrollment up to 12 weeks | Assessment of time to maximal concentration |
| The plasma area under the curve (AUC) of ABF-101 | From enrollment up to 12 weeks | Assessment of the plasma area under the curve |
| Terminal elimination half-life of ABF-101 | From enrollment up to 12 weeks | Assessment of terminal elimination half-life |
Countries
United States
Contacts
CONTACTClinical Center, Clinical Center
Outcome results
None listed