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Also known as HEC30654AcOH capsule
HEC30654AcOH · 1 trial · 1 indication
To assess the safe and tolerability of the single ascending-dose
To assess the safe and tolerability of the multiple ascending-dose
| Arm | Type | Description |
|---|---|---|
| HEC30654AcOH capsule | EXPERIMENTAL | single ascending-dose study: Including 7 dose groups(5-、10、15-、30-、60-、90-、120mg)，Day1 ante meridiem(AM) 8:00 (±1h) with 240ml warm water to taking the experiment drug，On an empty stomach . multiple ascending-dose study: Including 3 dose groups(15-、30-、60mg),Day1-Day7 AM 8:00 (±1h), 18:00 Post Meridiem(PM) (±1h), with 240ml warm water to take the experiment drug On an empty stomach;Day8 AM 8:00 (±1h)with 240ml warm water to taking the experiment drug，On an empty stomach. |
| placebo capsule | PLACEBO_COMPARATOR | single ascending-dose study: Including 6 dose groups(10、15-、30-、60-、90-、120mg)，Day1 morning 8:00 (±1h) with 240ml warm water to taking the placebo capsule，On an empty stomach . multiple ascending-dose study: Including 3 dose groups(15-、30-、60mg),Day1-Day7 AM 8:00 (±1h), 18:00 PM (±1h), with 240ml warm water to take the placebo capsule on an empty stomach;Day8 AM 8:00 (±1h)with 240ml warm water to taking the placebo capsule，on an empty stomach. |
| Name | Type | Description |
|---|---|---|
| HEC30654AcOH capsule | DRUG | single ascending-dose study: 5-、10-、15-、30-、60-、90-、120mg HEC30654AcOH capsule in day1. Multiple ascending-dose study: 15-、30-、60mgHEC30654AcOH capsule in day1-day7，2 times everyday. |
| Placebo capsule | DRUG | single ascending-dose study: 5-、10-、15-、30-、60-、90-、120mg placebo capsule in day1. Multiple ascending-dose study: 15-、30-、60mg placebo capsule in day1-day7，2 times everyday. |
Inclusion Criteria: * signing informed consent, and fully understanding the study's content, process，possible adverse reaction before the study beginning. * Be able to complete the study in accordance with the requirements of the study. * Subjects (including partner) which from screening to the las...
HEC30654AcOH is an investigational small molecule developed by Sunshine Biopharma Inc. (ticker SBFM). It is described as a selective 5-HT6 receptor antagonist and has been studied in a Phase 1 clinical trial in healthy adult subjects. The specific therapeutic indication for which it is being developed has not been disclosed.
HEC30654AcOH targets the 5-HT6 receptor, acting as a selective antagonist at that receptor. This target is identified in the title of its Phase 1 study, which describes the compound as a selective 5-HT6 receptor antagonist. The trial was conducted in healthy subjects rather than in a patient population.
HEC30654AcOH is developed by Sunshine Biopharma Inc., which trades under the ticker symbol SBFM. The company is the sponsor associated with the compound's clinical development program. No other development partners are identified for this asset.
HEC30654AcOH is in Phase 1 development. It has completed one Phase 1 clinical trial and has no active trials. The compound is investigational and has not been approved by the FDA. Its only recorded study was a completed Phase 1 trial conducted in China.
HEC30654AcOH has been studied in one completed Phase 1 trial, NCT03655873, titled "The Study of a Selective 5-ht6 Receptor Antagonist, HEC30654AcOH, in Healthy Subjects." The trial enrolled 43 participants in China, was randomized, double-blind, and placebo-controlled, and included healthy volunteers aged 18 years and older.
Yes. HEC30654AcOH capsule is an alternative name for HEC30654AcOH, referring to the same investigational compound developed by Sunshine Biopharma Inc. (SBFM). Searches using either name point to the same Phase 1 small molecule program and the same completed clinical study, NCT03655873.