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Also known as HEC83518 tablets
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 ...
Top 2 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Suvorexant |
| Vanda Pharmaceuticals Inc. | VNDA | 2 | PHASE3 | tasimelteon |
HEC83518 is an investigational small molecule being developed for the treatment of insomnia. It is a Phase 1 clinical-stage candidate developed by Sunshine Biopharma Inc. (ticker SBFM). It has been studied in two completed Phase 1 trials conducted in China, with a combined enrollment of 131 participants.
HEC83518 is being developed for insomnia, a psychiatric condition. Both completed Phase 1 trials enrolled participants with insomnia as the studied condition. The trials were conducted in China and included healthy volunteers aged 18 years and older.
HEC83518 is being developed by Sunshine Biopharma Inc., which trades under the ticker SBFM. The company is the sponsor behind the clinical development program for this insomnia candidate.
HEC83518 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no trials are currently active. The studies were randomized, double-blind, and placebo-controlled, with a total combined enrollment of 131 participants.
HEC83518 has been evaluated in two completed Phase 1 trials: NCT04667429, which enrolled 57 participants, and NCT04596007, which enrolled 74 participants. Both studied safety, tolerability, pharmacokinetics, and pharmacodynamics in insomnia and were conducted in China.
Yes. HEC83518 tablets is an alternative name for HEC83518, the investigational insomnia treatment developed by Sunshine Biopharma Inc. (SBFM). Both completed Phase 1 studies, NCT04667429 and NCT04596007, evaluated HEC83518 tablets.