Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HEC83518 · 2 trials · 1 indication
To assess the safety and tolerability of therapy
Safety and Tolerability of HEC83518 by Assessment of the Number of Adverse Events (AEs) Following Administration in Single Ascending Dose .
| Arm | Type | Description |
|---|---|---|
| Food effect | EXPERIMENTAL | HEC83518 40mg will be administered fasted, or with high-fat meal for once. |
| Multiple Ascending Doses-HEC83518 20mg | EXPERIMENTAL | HEC83518 20mg will be administered before sleep for 15 days . |
| Multiple Ascending Doses-HEC83518 40mg | EXPERIMENTAL | HEC83518 40mg will be administered before sleep for 15 days . |
| Multiple Ascending Doses-HEC83518 80mg | EXPERIMENTAL | HEC83518 80mg will be administered before sleep for 15 days . |
| Multiple Ascending Doses-placebo | PLACEBO_COMPARATOR | Placebo will be administered before sleep for 15 days . |
| HEC83518 tablets | EXPERIMENTAL | There will be a total of 7 dose cohorts: 5 mg,10 mg, 20 mg, 40 mg, 80 mg, and 140 mg,200 mg. |
| placebo tablets | PLACEBO_COMPARATOR | There will be a total of 6 dose cohorts: 10 mg, 20 mg, 40 mg, 80 mg, and 140 mg,200 mg. |
| Name | Type | Description |
|---|---|---|
| Food | OTHER | HEC83518 40mg will be taken orally fasted or with food |
| HEC83518 | DRUG | HEC83518 will be taken orally before sleep for 15 days |
| placebo | DRUG | The placebo will be administered before sleep for 15 days. |
| HEC83518 tablets | DRUG | Each dose of HEC83518 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight. |
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. 4. Healthy ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 3 | PHASE3 | Tasimelteon |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Suvorexant |
| Masimo Corporation | MASI | 1 | PHASE1 | Diprivan, Astra-Zeneca |
| ResMed Inc. | RMD | 1 | N/A | Undisclosed |
| IQVIA Holdings Inc | IQV | 1 | - | Daridorexant, Non-orexin receptor antagonist medications for insomnia |
HEC83518 is an investigational small molecule being developed for the treatment of insomnia. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics.
HEC83518 is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker symbol SBFM. The company is conducting clinical trials for this insomnia treatment candidate.
HEC83518 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers in China. The drug is investigational and has not yet received regulatory approval for the treatment of insomnia.
HEC83518 has been studied in two completed Phase 1 clinical trials: NCT04596007, which enrolled 74 healthy Chinese subjects, and NCT04667429, which enrolled 57 healthy subjects. Both trials evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of HEC83518 tablets in participants aged 18 years and older.
HEC83518 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for insomnia. The completed trials were conducted in China and focused on healthy volunteers, with no approval status indicated for any regulatory authority.