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Also known as HEC113995 PA•H2O tablets, HEC113995PA•H2O tablet
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 developed by Sunshine Biopharma Inc. (ticker: SBFM) for the treatment of Major Depressive Disorder. It is a tablet formulation that has been studied in a Phase 1 clinical trial in healthy subjects. It is not approved for any use.
HEC113995 PA•H2O is being developed for Major Depressive Disorder, a psychiatric condition. The only clinical study conducted to date evaluated the drug in healthy volunteers rather than in patients with depression, so its use in Major Depressive Disorder remains investigational.
Sunshine Biopharma Inc., which trades under the ticker SBFM, is the developer of HEC113995 PA•H2O. The company is advancing the small molecule tablet formulation for Major Depressive Disorder.
HEC113995 PA•H2O is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA or any other regulatory agency for Major Depressive Disorder.
HEC113995 PA•H2O has been studied in one completed Phase 1 trial, NCT04591301, titled "The Safety, Tolerability, and Pharmacokinetics Study of HEC113995 PA•H2O Tablets in Healthy Subjects." The trial enrolled 69 healthy volunteers in China and was randomized, double-blind, and placebo-controlled.
Yes. HEC113995 PA•H2O is also written as HEC113995PA•H2O, HEC113995 PA•H2O tablets, or HEC113995PA•H2O tablet. These names refer to the same investigational small molecule tablet developed by Sunshine Biopharma Inc. (SBFM) for Major Depressive Disorder.