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Also known as [14C]SSS17, SSS17 Capsule (6 Dose Levels)
SSS17 · 4 trials · 5 indications
| Arm | Type | Description |
|---|---|---|
| SSS17 | EXPERIMENTAL | The study employs a hybrid design with six dose levels: four fixed-dose parallel arms and two sequential dose-escalation cohort |
| placebo | PLACEBO_COMPARATOR | - |
| Fasting Group | OTHER | - |
| Low-fat Meal Concomitant Administration Group | OTHER | - |
| High-fat Meal 2-Hour Post-dose Group | OTHER | - |
| Name | Type | Description |
|---|---|---|
| SSS17 Capsule (6 Dose Levels) | DRUG | Arm1 ： This dose-ranging study evaluates 6 dose levels of oral SSS17 capsules under two regimens: Once weekly、 Twice weekly |
| Placebo Drug | DRUG | Arm2：placebo The placebo intervention was matched with the six dose levels of SSS17, with each dose level assigning participants in a ratio of 4:1 (SSS17 to placebo). |
| SSS17 | DRUG | The SSS17 treatment arm comprises three dose levels: the first two dose levels will have an 8-week treatment duration, while the third dose level will extend to 24 weeks. At each dose level, participants will be allocated in a 4:1 ratio (SSS17:placebo) for enrollment. |
| Placebo | DRUG | At each dose level, participants will be allocated in a 4:1 ratio (SSS17:placebo) for enrollment.Placebo recipients will undergo weekly dosing identical to the active treatment group within their assigned dose cohort. |
| [14C]SSS17 | DRUG | single oral dose |
Inclusion Criteria: 1. Signed informed consent obtained \- 2. Age 18-70 years (inclusive) \- 3. Candidates for hip/knee arthroplasty \- 4. No DVT on pre-op venous ultrasound \- 5. Screening Hb 80-110 g/L (no transfusion indication) - 6. Commitment to effective contraception Exclusi...
SSS17 is an investigational small molecule being developed for anemia in pre-dialysis patients and postoperative anemia, particularly after hip or knee arthroplasty. It is also studied in healthy subjects for pharmacokinetic and mass balance purposes. The drug is in Phase 2 clinical development.
SSS17 is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker SBFM. The company is conducting clinical trials of SSS17 in China for anemia-related conditions.
SSS17 is in Phase 2 clinical development. It has completed a Phase 2 dose-finding trial for anemia in non-dialysis chronic kidney disease and is planning a Phase 2a trial for postoperative anemia after arthroplasty. Phase 1 studies in healthy subjects have also been completed.
SSS17 has been studied in several trials. NCT07014631 is a completed Phase 2 dose-finding study for anemia in pre-dialysis patients. NCT07007936 is a planned Phase 2a trial for post-arthroplasty anemia. NCT07024888 is a completed Phase 1 food effect study, and NCT07025915 is a planned Phase 1 mass balance study.
Yes, [14C]SSS17 is a radiolabeled form of SSS17 used in a mass balance study to track the drug's absorption, distribution, metabolism, and excretion in healthy subjects. The drug is also referred to as SSS17 Capsule in clinical trial documentation.
No, SSS17 is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials. The drug has not yet completed the clinical development process required for regulatory approval.