Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HEC113995 · 1 trial · 1 indication
To assess the safety and tolerability of therapy
| Arm | Type | Description |
|---|---|---|
| Food effect | EXPERIMENTAL | HEC113995 20mg will be administered fasted, with regular meal or with high-fat meal for once. |
| Multiple Ascending Doses-HEC113995 10mg | EXPERIMENTAL | HEC113995 10mg will be administered fasted for 10 days |
| Multiple Ascending Doses-HEC113995 20mg | EXPERIMENTAL | HEC113995 20mg will be administered with food for 10 days |
| Multiple Ascending Doses-HEC113995 40mg | EXPERIMENTAL | HEC113995 40mg will be administered with food for 10 days |
| Multiple Ascending Doses-placebo | PLACEBO_COMPARATOR | Placebo arms will be administered fasted or with food for 10 days |
| Name | Type | Description |
|---|---|---|
| Food | OTHER | HEC113995 20mg will be taken orally fasted or with food |
| HEC113995 | DRUG | HEC113995 will be taken orally fasted (HEC113995 10mg）or with food (HEC113995 20mg and 40mg） for 10 days |
| placebo | DRUG | The placebo will be administered fasted or with food for 10 days. |
Inclusion Criteria: * 1\. Subjects who are willing and are able to provide a written informed consent to participate in the study. * 2\. Without Plan for pregnancy or pregnant within 3 months after enrollment throughout the trial. * 3\. Subjects aged between 18 and 45 (both inclusive) years old. * ...
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HEC113995 is an investigational small molecule being developed for the treatment of Major Depressive Disorder. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its safety, tolerability, and pharmacokinetics in clinical trials.
HEC113995 is being developed by Sunshine Biopharma Inc., a biopharmaceutical company traded on the stock market under the ticker symbol SBFM. The company is conducting clinical research on this investigational drug for the treatment of Major Depressive Disorder.
HEC113995 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is being studied for the treatment of Major Depressive Disorder, and its Phase 1 trial has been completed.
HEC113995 has one completed clinical trial identified as NCT04623814, titled "The Safety, Tolerability, and Pharmacokinetics Study of HEC113995." This Phase 1 study enrolled 58 participants in China and included healthy volunteers. The trial was randomized, double-blind, and placebo-controlled.
HEC113995 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of Major Depressive Disorder. The drug has completed a Phase 1 clinical trial, but it remains in clinical development and has not received regulatory approval.