Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied in healthy subjects. It is a selective 5-HT6 receptor antagonist. The drug is currently in Phase 1 clinical development, meaning it has not been approved for any medical use and is still being evaluated in clinical trials.
HEC30654AcOH targets the 5-HT6 receptor, acting as a selective antagonist. This means it binds to and blocks the 5-HT6 receptor, which is a subtype of serotonin receptor. The drug is being developed by Sunshine Biopharma Inc. as a small molecule therapeutic.
HEC30654AcOH is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker SBFM. The drug is currently in Phase 1 clinical development as an investigational small molecule.
HEC30654AcOH is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in healthy subjects as part of its initial safety and tolerability evaluation.
HEC30654AcOH has one completed Phase 1 clinical trial registered as NCT03655873. The study, titled 'The Study of a Selective 5-ht6 Receptor Antagonist, HEC30654AcOH, in Healthy Subjects,' was conducted in China with 43 participants. It was a randomized, double-blind, placebo-controlled trial.
Yes, HEC30654AcOH is a selective 5-HT6 receptor antagonist. This means it works by blocking the 5-HT6 receptor, a subtype of serotonin receptor. The drug is being developed by Sunshine Biopharma Inc. and is currently in Phase 1 clinical trials.