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HEC122505MsOH · 1 trial · 1 indication
To investigate the safety and tolerability of HEC122505MsOH by assessment of AEs (non-serious and serious) following administration of oral HEC122505MsOH tablets
| Arm | Type | Description |
|---|---|---|
| Single dose of HEC122505MsOH Tablets（pilot trial arm） | EXPERIMENTAL | Healthy subjects receive single dose of tablets HEC122505MsOH |
| Single dose of HEC122505MsOH Tablets（Part 1， Cohort 1） | EXPERIMENTAL | Healthy subjects receive single dose of HEC122505MsOH or matching placebo |
| Single dose of HEC122505MsOH Tablets（Part 1， Cohort 2） | EXPERIMENTAL | Healthy subjects receive single dose of HEC122505MsOH tablets or matching placebo |
| Single dose of HEC122505MsOH Tablets（Part 1， Cohort 3,Fed/Fasting） | EXPERIMENTAL | Following an overnight fast of at least 10 hours, a single dose of HEC585 will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions. |
| Single dose of HEC122505MsOH Tablets（Part 1， Cohort 4） | EXPERIMENTAL | Healthy subjects receive single dose of HEC122505MsOH tablets or matching placebo |
| Single dose of HEC122505MsOH Tablets（Part 1，Cohort 5） | EXPERIMENTAL | Healthy subjects receive single dose of HEC122505MsOH tablets or matching placebo |
| Single dose of HEC122505MsOH Tablets（Part 1， Cohort 6） | EXPERIMENTAL | Healthy subjects receive single dose of HEC122505MsOH tablets or matching placebo |
| Multiple doses of HEC122505MsOH Tablets（Part 2， Cohort 1） | EXPERIMENTAL | Healthy subjects receive multiple doses of HEC122505MsOH tablets or matching placebo |
| Multiple doses of HEC122505MsOH Tablets（Part 2， Cohort 2） | EXPERIMENTAL | Healthy subjects receive multiple doses of HEC122505MsOH tablets or matching placebo |
| Multiple doses of HEC122505MsOH Tablets（Part 2， Cohort 3） | EXPERIMENTAL | Healthy subjects receive multiple doses of HEC122505MsOH tablets or matching placebo |
| Name | Type | Description |
|---|---|---|
| HEC122505MsOH | DRUG | Part2：Mulltiple doses once daily, up to 8 days |
Inclusion Criteria: 1. Subjects who are willing and are able to provide a written informed consent to participate in the study. 2. Without Plann for pregnancy or pregnant within 3 months after enrollment throughout the trial. 3. Subjects aged between 18 and 45 (both inclusive) years old. 4. Healthy...
HEC122505MsOH is an investigational small molecule being developed for Parkinson Disease. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied for its safety, tolerability, and pharmacokinetic profile in healthy adult subjects.
HEC122505MsOH 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 drug candidate in the neurology therapeutic area.
HEC122505MsOH is in Phase 1 clinical development. A Phase 1 study has been completed, which evaluated single and multiple dose safety, tolerability, pharmacokinetics, and food effects of the drug in healthy adult subjects. The drug remains investigational and has not received regulatory approval.
HEC122505MsOH has one completed clinical trial registered under NCT04625361. This Phase 1 study, titled 'Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC122505MsOH Tablets in Healthy Adult Subjects,' enrolled 106 participants in China. The trial was randomized, double-blind, and controlled.
HEC122505MsOH is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Parkinson Disease. The completed Phase 1 trial focused on safety and tolerability in healthy volunteers, and the drug has not yet progressed through the later stages required for regulatory approval.