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HEC116094 · 1 trial · 1 indication
To investigate the safety and tolerability of HEC116094 by assessment of AEs
| Arm | Type | Description |
|---|---|---|
| Single dose of HEC116094（Part A, Cohort 1） | EXPERIMENTAL | Healthy subjects receive sinele dose of HEC116094 |
| Single dose of HEC116094（Part A, Cohort 2） | EXPERIMENTAL | Healthy subjects receive sinele dose of HEC116094 or matching placebo |
| Single dose of HEC116094（Part A, Cohort 3） | EXPERIMENTAL | Healthy subjects receive sinele dose of HEC116094 or matching placebo |
| Single dose of HEC116094（Part A, Cohort 4，Fed/Fasting） | EXPERIMENTAL | Following an overnight fast of at least 10 hours, a single dose of HEC116094 will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions. |
| Single dose of HEC116094（Part A, Cohort 5） | EXPERIMENTAL | Healthy subjects receive sinele dose of HEC116094 or matching placebo |
| Single dose of HEC116094（Part A, Cohort 6） | EXPERIMENTAL | Healthy subjects receive sinele dose of HEC116094 or matching placebo |
| Single dose of HEC116094（Part A, Cohort 7） | EXPERIMENTAL | Healthy subjects receive sinele dose of HEC116094 or matching placebo |
| Mulltiple doses HEC116094（ Part B, Cohort 1） | EXPERIMENTAL | Healthy subjects receive multiple doses of HEC116094 or matching placebo |
| Mulltiple doses HEC116094（ Part B, Cohort 2） | EXPERIMENTAL | Healthy subjects receive multiple doses of HEC116094 or matching placebo |
| Mulltiple doses HEC116094（ Part B, Cohort 3） | EXPERIMENTAL | Healthy subjects receive multiple doses of HEC116094 or matching placebo |
| Mulltiple doses HEC116094（ Part B, Cohort 4） | EXPERIMENTAL | Healthy subjects receive multiple doses of HEC116094 or matching placebo |
| The interaction with Oseltamivir of HEC116094（ Part C） | EXPERIMENTAL | Healthy subjects received HEC116094 in cycle 1, Oseltamivir in cycle 2, and a combination of HEC116094 and Oseltamivir in cycle 3.There are washout periods between the first cycle and the second cycle and between the second cycle and the third cycle |
| Name | Type | Description |
|---|---|---|
| HEC116094 | DRUG | Part B：Mulltiple doses up to 5 days； Part C：Each cycle was administered for 5 days |
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...
HEC116094 is an investigational small molecule being developed for the treatment of influenza. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
HEC116094 is being developed by Sunshine Biopharma Inc., a company traded on the NASDAQ under the ticker symbol SBFM. The drug is in Phase 1 clinical development for influenza.
HEC116094 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational, meaning it has not yet received regulatory approval.
HEC116094 has one completed Phase 1 clinical trial, identified as NCT04982913. This study evaluated single and multiple dose safety, tolerability, pharmacokinetics, food effects, and interaction with oseltamivir in healthy adult subjects in China.
HEC116094 is not the same as oseltamivir. The Phase 1 trial NCT04982913 studied HEC116094 in combination with oseltamivir to assess potential drug interactions, indicating they are distinct antiviral agents.