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 being developed by Regeneron Pharmaceuticals, Inc. It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, with one completed clinical trial assessing its safety, tolerability, and bioeffect.
REGN1193 is being studied for use in healthy volunteers. The completed Phase 1 trial evaluated the safety, tolerability, and bioeffect of the drug. It is not approved for any specific disease or condition and remains in clinical development.
REGN1193 is developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol REGN. Regeneron conducted a Phase 1 clinical trial of REGN1193 in the United States.
REGN1193 is in Phase 1 clinical development. The drug has completed one Phase 1 trial, which was a randomized, double-blind, controlled study in healthy volunteers. REGN1193 is investigational and has not been approved by regulatory authorities.
REGN1193 has one completed clinical trial, identified as NCT01933763. This was a Phase 1 ascending single-dose study evaluating the safety, tolerability, and bioeffect of REGN1193 in healthy volunteers. The trial enrolled 56 participants in the United States.