Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06432647 | A SAD and MAD Study of the Safety, Tolerability, and Pharmacokinetics of ATH-1105 | PHASE1 | COMPLETED | 80 | — | — | Apr 24, 2024 | Nov 25, 2024 | Jan 23, 2025 | 1 | United States |
Safety and tolerability of single or multiple ascending doses of ATH-1105 as measured by incidence of AEs, determined by clinical laboratory tests, physical examinations, vital signs measurements, and 12-lead ECG
Treatment-emergent adverse events will be graded on a 1 through 5 scale, based on severity as determined by the principal investigator.
| Arm | Type | Description |
|---|---|---|
| ATH-1105 | EXPERIMENTAL | Part A: ATH-1105 administered once as an oral solution. Part B: ATH-1105 administered once daily as an oral solution for 10 days. |
| Placebo | PLACEBO_COMPARATOR | Part A: Placebo administered once as an oral solution Part B: Placebo administered once daily as an oral solution |
| Name | Type | Description |
|---|---|---|
| ATH-1105 | DRUG | ATH-1105 in oral form. Participants will be administered ATH-1105 once in Part A and once daily for 10 days in Part B. |
| Placebo | DRUG | Placebo in oral form. Participants will be administered Placebo once in Part A and once daily for 10 days in Part B. |
Inclusion Criteria: * Body mass index between 18.0 and 32.0 kg/m2 inclusive. * In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at screening and check-in or predose on Day 1 * Females wi...