Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HEC93077 · 1 trial · 1 indication
To investigate the safety and tolerability by assement of AEs following administration of oral solution in SAD and MAD
Area Under the Curve(AUC)
Geometric Mean of Maximum Observed Plasma Concentration of HEC93077
maximum observed plasma concentration
apparent terminal elimination half-life
apparent volume of distribution
Percentage of serum uric acid changed from baseline
The amount of drug excreted in the urine
The amount of drug excreted in the feces
The cumulative rate of durg excreted through urine/feces
| Arm | Type | Description |
|---|---|---|
| single dose of HEC93077（pilot trial arm） | EXPERIMENTAL | Healthy subjects receive single dose of HEC93077 |
| single dose of HEC93077（Cohort 1） | EXPERIMENTAL | Healthy subjects receive sinele dose of HEC93077 or matching placebo |
| single dose of HEC93077（Cohort 2） | EXPERIMENTAL | Healthy subjects receive sinele dose of HEC93077 or matching placebo |
| single dose of HEC93077（Cohort 3,Fed/Fasting） | EXPERIMENTAL | Following an overnight fast of at least 10 hours, a single dose of HEC93077 or placebo will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions. |
| single dose of HEC93077（Cohort 4） | EXPERIMENTAL | Healthy subjects receive sinele dose of HEC93077 or matching placebo |
| single dose of HEC93077（Cohort 5） | EXPERIMENTAL | Healthy subjects receive sinele dose of HEC93077 or matching placebo |
| single dose of HEC93077（Cohort 6） | EXPERIMENTAL | Healthy subjects receive sinele dose of HEC93077 or matching placebo |
| single dose of HEC93077（Cohort 7） | EXPERIMENTAL | Healthy subjects receive sinele dose of HEC93077 or matching placebo |
| multiple doses of HEC93077（ Cohort 8） | EXPERIMENTAL | Healthy subjects receive multiple doses of HEC93077 or matching placebo |
| multiple doses of HEC93077（ Cohort 9, Group 1) | EXPERIMENTAL | Healthy subjects receive multiple doses of HEC93077 or matching placebo |
| multiple doses of HEC93077（ Cohort 9, Gruop 2) | EXPERIMENTAL | Hyperuricemia subjects receive multiple doses of HEC93077 or matching placebo |
| multiple doses of HEC93077（ Cohort 10) | EXPERIMENTAL | Healthy subjects receive multiple doses of HEC93077 or matching placebo |
| Name | Type | Description |
|---|---|---|
| HEC93077 | DRUG | Paticipants recieve HEC93077 orally single or Mulltiple doses up to 14 days |
| Placebo | DRUG | Paticipants recieve placebo matching HEC93077 orally single or Mulltiple doses up to 14 days |
Healthy Subjects： Inclusion Criteria: 1. Subjects who are willing and are able to provide a written informed consent to participate in the study. 2. Subjects aged between 18 and 45 (both inclusive) years old. 3. Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Amgen Inc. | AMGN | 1 | PHASE3 | Pegloticase, Methotrexate |
| Protalix BioTherapeutics, Inc. (DE) | PLX | 1 | PHASE2 | PRX-115, Methotrexate |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 1 | PHASE1 | NNC4004-0002 |
| TJ Biopharma Co., Ltd. | IMAB | 1 | PHASE2 | Plonmarlimab, Compound betamethasone |
| Sunshine Biopharma Incorporated | SBFM | 1 | PHASE1 | Pegylated Recombinant Candida Utilis Uricase |
HEC93077 is an investigational small molecule being developed for the treatment of gout. It is currently in Phase 1 clinical development and has been studied in a completed trial involving healthy subjects and patients with hyperuricemia (HUA), a condition often associated with gout.
HEC93077 is being developed by Sunshine Biopharma Inc., a company traded on the stock exchange under the ticker symbol SBFM. The company is conducting clinical research on this small molecule for the treatment of gout.
HEC93077 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. A Phase 1 trial has been completed, and the drug remains under investigation for the treatment of gout.
HEC93077 has been studied in a completed Phase 1 clinical trial with the identifier NCT05127772. This trial, titled 'A Clinical Trial of HEC93077 in Chinese Healthy Subjects and HUA Patients With Single or Multiple Dosing,' enrolled 126 participants in China and included healthy volunteers.
HEC93077 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of gout. The drug has completed a Phase 1 trial, but it has not yet received regulatory approval for marketing.