Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN1193 · 1 trial · 1 indication
The primary endpoint in this study is the incidence and severity of TEAEs (treatment emergent adverse events) in healthy volunteers treated with REGN1193 or placebo reported from day 1 (baseline) to the completion of the study on day 106/ visit 16.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Participants in Group A will consist of up to 6 sequential ascending dose cohorts. Each cohort will therefore receive 1 of 6 ascending dosing levels of the study drug (REGN1193) or placebo. |
| Group B | EXPERIMENTAL | Participants in Group B will consist of up to 6 sequential ascending dose cohorts. Each cohort will therefore receive 1 of 6 ascending dosing levels of the study drug (REGN1193) or placebo. |
| Name | Type | Description |
|---|---|---|
| REGN1193 | DRUG | - |
| Placebo | OTHER | - |
Inclusion Criteria: 1. Healthy men and women 18 to 45 years of age (inclusive) 2. Body mass index 18.0 to 30.0 kg/m\^2 (inclusive) 3. Normal standard 12-lead ECG 4. Willing and able to comply with clinic visits and study-related procedures 5. Provide signed informed consent 6. For sexually active m...
REGN1193 is an investigational small molecule therapeutic being developed by Regeneron Pharmaceuticals, Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The specific disease indications for REGN1193 have not been publicly disclosed.
REGN1193 is being developed by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker symbol REGN. Regeneron is the sponsor of the clinical program for this investigational small molecule.
REGN1193 is in Phase 1 clinical development. It has completed one Phase 1 trial, and no active trials are currently listed. As an investigational drug, REGN1193 has not been approved by the FDA for any indication.
REGN1193 has been evaluated in one completed Phase 1 trial, NCT01933763, titled an ascending single-dose study of the safety, tolerability and bioeffect of REGN1193. The trial enrolled 56 healthy adult volunteers in the United States and was randomized, double-blind, and controlled.
REGN1193 does not have a publicly disclosed therapeutic indication. Its only listed clinical trial was conducted in healthy volunteers rather than in patients with a specific disease, so no approved or investigational use in a patient population has been announced.