Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as HEC169584 capsule
HEC169584 · 1 trial · 1 indication
Evaluate the safety and tolerability of single/multiple administrations of HEC169584 capsules in healthy subjects.
| Arm | Type | Description |
|---|---|---|
| Dose group-1 | EXPERIMENTAL | On day1 subjects will take the experiment drug on an empty stomach with 240ml warm water. |
| Dose group-2 | SHAM_COMPARATOR | Single ascending-dose study: on day1 subjects will take the 30 mg experiment drug on an empty stomach with 240ml warm water ; |
| Dose group-3 | SHAM_COMPARATOR | Single ascending-dose study: on day1, subjects will take 70 mg the experiment drug or placeble on an empty stomach with 240ml warm water. |
| Dose group-4 | SHAM_COMPARATOR | Single ascending-dose study: on day1, subjects will take 150 mg the experiment drug or placeble on an empty stomach with 240ml warm water. |
| Dose group-5 | SHAM_COMPARATOR | Single ascending-dose study: on day1, subjects will take 300 mg the experiment drug or placeble on an empty stomach with 240ml warm water. Subjects also need to take experiment drug after high - fat and high - calorie meals on day 15 |
| Dose group-6 | SHAM_COMPARATOR | Single ascending-dose study: on day1, subjects will take 450 mg the experiment drug or placeble on an empty stomach with 240ml warm water. |
| Dose group-7 | SHAM_COMPARATOR | Single ascending-dose study: on day1, subjects will take 600 mg the experiment drug or placeble on an empty stomach with 240ml warm water. |
| Dose group-8 | SHAM_COMPARATOR | Arm Description: Single ascending-dose study: on day1, subjects will take 800 mg the experiment drug or placeble on an empty stomach with 240ml warm water. |
| Dose group-9 | SHAM_COMPARATOR | Multiple ascending-dose study: Day1-Day14 , subjects will take 70 mg, QD experiment drug or placeble with 240ml warm water on an empty stomach. |
| Dose group-10 | SHAM_COMPARATOR | Multiple ascending-dose study: Day1-Day14 , subjects will take 150 mg, QD experiment drug or placeble with 240ml warm water on an empty stomach. |
| Dose group-11 | SHAM_COMPARATOR | Multiple ascending-dose study: Day1-Day14 , subjects will take 300 mg, QD experiment drug or placeble with 240ml warm water on an empty stomach. |
| Name | Type | Description |
|---|---|---|
| HEC169584 capsule | DRUG | Each dose of HEC83518 will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight. |
| placebo | DRUG | The placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight. |
Inclusion Criteria: 1. Subjects should understand and abide by the research procedures, volunteer to participate, and sign the informed consent form. 2. When signing the informed consent form, subjects should be between 18 and 45 years old (including the boundary values), and both genders are eligi...
HEC169584 is an investigational small molecule being developed for the treatment of Non-Alcoholic Steatohepatitis (NASH). It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied as an oral capsule formulation.
HEC169584 is being developed by Sunshine Biopharma Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SBFM. The company is conducting clinical trials for this investigational drug candidate in China.
HEC169584 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is actively recruiting participants to evaluate the drug's safety, tolerability, and pharmacokinetics.
HEC169584 is being evaluated in a Phase 1 clinical trial registered as NCT07099118. This randomized, double-blind, sham-controlled study is titled "A Safety, Tolerability, Pharmacokinetics/Pharmacodynamics Study of HEC169584 Capsules in Healthy Subjects" and is being conducted in China with a planned enrollment of 96 participants.
Yes, HEC169584 and HEC169584 capsule refer to the same drug product. The capsule is the oral dosage form of the investigational drug HEC169584, which is being studied for the treatment of Non-Alcoholic Steatohepatitis (NASH).