Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HEC113995PA•H2O · 1 trial · 1 indication
To assess the safe and tolerability of the single ascending-dose
| Arm | Type | Description |
|---|---|---|
| HEC113995PA•H2O tablet | EXPERIMENTAL | Including 7 dose groups(2.5-、5、10-、20-、40-、60-、80mg).Each dose group was given only once.After an overnight stay of at least 10h on an empty stomach, 240mL of water was administered in the morning under the condition of an empty stomach. Water was forbidden for 1h before and 1h after administration, and fasting for 4h after administration. |
| placebo tablet | PLACEBO_COMPARATOR | Including 7 dose groups(2.5-、5、10-、20-、40-、60-、80mg).Each dose group was given only once.After an overnight stay of at least 10h on an empty stomach, 240mL of water was administered in the morning under the condition of an empty stomach. Water was forbidden for 1h before and 1h after administration, and fasting for 4h after administration. |
| Name | Type | Description |
|---|---|---|
| HEC113995PA•H2O tablet | DRUG | 2.5-、5-、10-、20-、40-、60-、80mg HEC113995PA•H2O tablet in day1. |
| Placebo tablet | DRUG | 2.5-、5-、10-、20-、40-、60-、80mg Placebo tablet in day1. |
Inclusion Criteria: * Willing to participate in the study, able to understand and sign the informed consent, and able to complete the the study in accordance with the requirements of the study. * Female subjects who are not pregnant or lactating and male subjects whose female partners are fertile s...
HEC113995 PA•H2O is an investigational small molecule being studied for the treatment of Major Depressive Disorder. It is also being evaluated in healthy subjects to assess its safety, tolerability, and pharmacokinetics. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
HEC113995 PA•H2O is described as a selective serotonin partial agonist and reuptake inhibitor. This means it is designed to interact with serotonin pathways in the brain, acting as a partial agonist at serotonin receptors and inhibiting serotonin reuptake, which may help regulate mood in Major Depressive Disorder.
HEC113995 PA•H2O 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 to evaluate the drug's safety and efficacy in treating Major Depressive Disorder.
HEC113995 PA•H2O is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy subjects. The drug is still investigational and has not received FDA approval. It is being studied for its safety, tolerability, and pharmacokinetic profile.
HEC113995 PA•H2O has been studied in two completed Phase 1 clinical trials. The first, NCT03943251, evaluated the drug in healthy subjects in China. The second, NCT04591301, assessed the safety, tolerability, and pharmacokinetics of HEC113995 PA•H2O tablets in healthy subjects, also in China. Both trials were randomized, double-blind, and placebo-controlled.
HEC113995 PA•H2O is a specific form of the drug HEC113995, where PA•H2O refers to the particular salt or hydrate form used in the clinical trials. The trials listed for this drug use the name HEC113995 PA•H2O, indicating it is the active pharmaceutical ingredient in this specific formulation.