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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05169671 | Safety, Tolerability, and Pharmacokinetics Study of ATH-1020 | PHASE1 | COMPLETED | 32 | — | — | Mar 30, 2022 | Sep 9, 2022 | Apr 8, 2024 | 1 | United States |
Safety and tolerability of single or multiple ascending doses of ATH-1020 as measured by vital signs and clinical laboratory measurements.
| Arm | Type | Description |
|---|---|---|
| ATH-1020 | EXPERIMENTAL | ATH-1020 in oral form. Participants in the single ascending dose cohort (Cohort A) will receive a single dose of ATH-1020. Participants in the multiple ascending dose cohort (Cohort B) will receive up to nine doses of ATH-1020 (up to 4 for cohort B5). |
| Placebo | PLACEBO_COMPARATOR | Placebo in oral form. Participants in the single ascending dose cohort (Cohort A) will receive a single dose of Placebo. Participants in the multiple ascending dose cohort (Cohort B) will receive up to nine doses of placebo. |
| Name | Type | Description |
|---|---|---|
| ATH-1020 | DRUG | ATH-1020 in oral capsule form |
| Placebo | DRUG | Placebo in oral capsule form |
Inclusion Criteria: All Subjects 1. Body mass index (BMI) of ≥ 18.0 and ≤ 32.0 kg/m2 at Screening, with minimum weight of 60 kg. 2. Subjects in generally good health per the investigator's discretion. 3. Male subjects and their partners must be willing to comply with the contraceptive requirements...