Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RTA 901, 10 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| RTA 901 10 mg or 40 mg or Placebo | EXPERIMENTAL | RTA 901 capsules (10 mg or 40 mg) or placebo taken orally in a single dose. Group 1: RTA 901 10 mg or matching placebo Group 2: RTA 901 20 mg or matching placebo Group 3: RTA 901 ≤ 40 mg or matching placebo Group 4: RTA 901 ≤ 80 mg or matching placebo Group 5: RTA 901 ≤ 160 mg or matching placebo Group 6: RTA 901 ≤ 320 mg or matching placebo Group 7: RTA 901 ≤ 640 mg or matching placebo Dose selection will be based on the safety, tolerability and available pharmacokinetics observed in prior study groups. |
| RTA 901 Dose TBD or Placebo | EXPERIMENTAL | RTA 901 capsules, Dose TBD mg or placebo taken orally once daily for 14 days. Group 8: RTA 901 X mg or matching placebo Group 9: RTA 901 ≤Y mg or matching placebo Group 10: RTA 901 ≤Z mg or matching placebo The actual doses for Arm 2 will be selected based on the safety and available pharmacokinetic data obtained from Arm 1. |
| Name | Type | Description |
|---|---|---|
| RTA 901 Capsules, 10 or 40 mg | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Male or female and age is between 18 and 55 years, inclusive. * Women must be of non-childbearing potential and may not be pregnant, lactating, or breast-feeding. Non-childbearing potential is defined by at least one of the following criteria: 1. At least 2 years spontaneou...
RTA 901 is an investigational small molecule developed by Biogen Inc. (ticker BIIB). It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The specific disease or condition it is intended to treat has not been disclosed.
RTA 901 is being developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. Biogen sponsored the Phase 1 study of the compound in healthy adult participants.
RTA 901 is in Phase 1 development. It is an investigational drug and is not approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for the compound.
RTA 901 has been evaluated in one completed Phase 1 trial, NCT02666963, titled A Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of RTA 901 in Healthy Adults. The trial enrolled 78 healthy volunteers in the United States.
The Phase 1 trial NCT02666963 was a randomized, double-blind, controlled study of single and multiple doses of RTA 901 in healthy adults aged 18 years and older. It enrolled 78 participants in the United States and has been completed.