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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03579030 | Safety and PK/PD of RTA 1701 in Healthy Adults | PHASE1 | COMPLETED | 90 | — | — | Jun 20, 2018 | Jun 28, 2019 | May 29, 2025 | 1 | Australia |
Safety will be assessed based on the number of treatment-emergent adverse events
| Arm | Type | Description |
|---|---|---|
| Single Dose of RTA 1701 or Placebo | EXPERIMENTAL | RTA 1701 capsules or placebo taken orally in a single dose. Group 1: RTA 1701 10 mg or matching placebo Group 2: RTA 1701 ≤ 20 mg or matching placebo Group 3: RTA 1701 ≤ 40 mg or matching placebo Group 4: RTA 1701 ≤ 80 mg or matching placebo Group 5: RTA 1701 ≤ 160 mg or matching placebo Group 6: RTA 1701 ≤ 320 mg or matching placebo Group 7: RTA 1701 ≤ 640 mg or matching placebo |
| Multiple Dose of RTA 1701 or Placebo | EXPERIMENTAL | RTA 1701 capsules, Dose TBD mg or placebo taken orally once daily for 14 weeks. Group 8: RTA 1701 ≤40 mg or matching placebo Group 9: RTA 1701 ≤160 mg or matching placebo Group 10: RTA 1701 ≤640 mg or matching placebo |
| Name | Type | Description |
|---|---|---|
| Placebo oral capsule | DRUG | Placebo capsule matched to an RTA 1701 capsule |
| RTA 1701 capsules | DRUG | Capsule containing RTA 1701, multiple dosages |
Inclusion Criteria: * Male or female and age is between 18 and 55 years, inclusive; * Female participants of childbearing potential must: * Not be pregnant, or lactating, or planning a pregnancy, and * Be willing to use contraception (hormonal contraceptives, diaphragm, or intrauterine contraceptio...