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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A (ABF-101 or Placebo) | Experimental |
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| Part B (ABF-101 or Placebo) | Experimental |
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| Part C (ABF-101) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABF-101 | Drug | orally, QD |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | From enrollment up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of ABF-101 | Assessment of the maximum observed plasma concentration | From enrollment up to 12 weeks |
| Time to maximal concentration (Tmax) of ABF-101 |
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Inclusion Criteria:
Part A and B
Part C
Exclusion Criteria:
Part A and B
Part C
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Center, Clinical Center | Contact | +82-31-365-3693 | cd@aptabio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dallas Clinical Research Unit | Recruiting | Dallas | Texas | 75247 | United States |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| Placebo | Drug | orally, QD |
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Assessment of time to maximal concentration
| From enrollment up to 12 weeks |
| The plasma area under the curve (AUC) of ABF-101 | Assessment of the plasma area under the curve | From enrollment up to 12 weeks |
| Terminal elimination half-life of ABF-101 | Assessment of terminal elimination half-life | From enrollment up to 12 weeks |