Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HEC113995 PA•H2O · 1 trial · 1 indication
To investigate the safety and tolerability of HEC113995 PA•H2O by assessment of AEs (non-serious and serious) following administration in SAD
| Arm | Type | Description |
|---|---|---|
| HEC113995 PA•H2O 2.5mg | EXPERIMENTAL | Healthy subjects are given HEC113995 PA•H2O 2.5 mg in a single dose. |
| HEC113995 PA•H2O 5mg | ACTIVE_COMPARATOR | Healthy subjects are given HEC113995 PA•H2O 5 mg in a single dose. |
| HEC113995 PA•H2O 10mg | ACTIVE_COMPARATOR | Healthy subjects are given HEC113995 PA•H2O 10 mg in a single dose. |
| HEC113995 PA•H2O 20mg | ACTIVE_COMPARATOR | Healthy subjects are given HEC113995 PA•H2O 20 mg in a single dose. |
| HEC113995 PA•H2O 40mg | ACTIVE_COMPARATOR | Healthy subjects are given HEC113995 PA•H2O 40 mg in a single dose. |
| HEC113995 PA•H2O 60mg | ACTIVE_COMPARATOR | Healthy subjects are given HEC113995 PA•H2O 60 mg in a single dose. |
| HEC113995 PA•H2O 80mg | ACTIVE_COMPARATOR | Healthy subjects are given HEC113995 PA•H2O 80 mg in a single dose. |
| placebo | PLACEBO_COMPARATOR | Healthy subjects are given placebo in a single dose. |
| Name | Type | Description |
|---|---|---|
| HEC113995 PA•H2O tablets | DRUG | Each dose of HEC113995 PA•H2O tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight. |
| Placebo tablets | DRUG | Placebo tablets 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. * ...
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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.