Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fifth Affiliated Hospital of Guangzhou Medical University | OTHER |
Not provided
Not provided
Not provided
Not provided
This study will investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of single oral administration of 5 mg, 15 mg, 20 mg and 25 mg of SSS17 compared with placebo, and evaluate the efficacy, safety, tolerance, pharmacokinetics and pharmacodynamics of multiple oral administration of 15 mg and 20 mg of SSS17 compared with placebo. In addition, the study will assess the effect of food on the pharmacokinetics of SSS17.
The study will enroll healthy volunteers from a single academic medical center in China. All participants will be informed about the study and potential risks and required to provide written informed consent prior to undergoing study-related procedures.The study will be divided into 3 parts.
Part 1: Subjects will be allocated 2:8 to receive placebo or SSS17（it was only 2:2 in 5mg dose group）,which will be administered by oral route with single dose. At each dose, tolerability, safety, PK and PD characteristics will be investigated.
Part 2: Subjects will be allocated 2:8 to receive placebo or SSS17, which will be administered by oral route with multiple dose. At each cohort，tolerability, safety, PK and PD characteristics will be investigated.
Part 3: The subjects will receive two cycles of treatment, one is given on an empty stomach, the other is given after a high-fat meal, with an interval of 15 days.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Single Dose Escalation SSS17 | Experimental | Escalating doses of SSS17, single dose administration |
|
| Part 1: Single Dose Escalation matching Placebo | Placebo Comparator | Escalating doses of matching placebo, single dose administration |
|
| Part 2: Multiple Dose Escalation SSS17 | Experimental | Escalating doses of SSS17, multiple dose administration |
|
| Part 2: Multiple Dose Escalation matching Placebo | Placebo Comparator | Escalating doses of matching placebo, multiple dose administration |
|
| Part 3: Treatment Sequence 1 (A to B) | Experimental | The subjects in the first cycle received oral administration of SSS17 on an empty stomach, and subjects in the second cycle received oral administration of SSS17 after a high-fat meal |
|
| Part 3: Treatment Sequence 2 (B to A) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSS17 | Drug | SSS17 is a novel small molecule compound which stimulates erythropoiesis through inhibition of hypoxiainducible factor- prolyl hydroxylases( HIF-PH). It is being developed for the treatment of anemia in patients with chronic kidney disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: AEs | Assessment AEs by frequency and severity in the part 1 | Baseline up to Days 15 |
| Part 1: Maximum plasma concentration (Cmax) of SSS17 | Plasma samples will be collected and Cmax will be assessed in the part 1 | Up to 336 hours post-dose |
| Part 1: Area under the concentration-time curve (AUC) of plasma concentration of SSS17 | Plasma samples will be collected and the AUC from zero to infinity will be assessed in the part 1 | Up to 336 hours post-dose |
| Part 1: Time-to-Cmax (Tmax) of SSS 17 | Plasma samples will be collected and the Tmax will be assessed from the concentration-time curve in the part 1 | Up to 336 hours post-dose |
| Part 1: Elimination terminal half-life (t1/2) of SSS17 | Plasma samples will be collected and the t1/2 will be assessed in the part 1 | Up to 336 hours post-dose |
| Part 1: . Total amount of SSS17 excreted in urine over 72 hours (Ae0-72) | Urine sample will be collected at pre-specified intervals and Ae0-72 will be assessed in the part 1 | Up to 72 hours post-dose |
| Part 1: Fraction of SSS17 excretion during each collection interval (Fe0-72) | Urine sample will be collected at pre-specified intervals and Fe0-72 will be assessed in the part 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: EPO concentrations | Change of EPO concentrations from baseline following SSS17 in the part 1 | Up to 168 hours post-dose |
| Part 1: VEGF concentrations | Change of VEGF concentrations from baseline following SSS17 in the part 1 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Director Li | Contact | 18028886429 | 747560265@qq.com | |
| Professor Fang, Ph.D | Contact | 13701165926 | fygk7000@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510700 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Experimental |
The subjects in the first cycle received oral administration of SSS17 after a high-fat meal, and the subjects in the second cycle received oral administration of SSS17 on an empty stomach |
|
| Placebo | Drug | Matched placebo. |
|
| Up to 72 hours post-dose |
| Part 1: Renal clearance (CLR) of SSS17 | Urine sample will be collected at pre-specified intervals and CLR will be assessed in the part 1 | Up to 72 hours post-dose |
| Part 2: AEs | Assessment AEs by frequency and severity in the part 2 | Up to Days 33 or 57 |
| Part 2: Steady state minimal concentration (Css_min) of SSS17 | Plasma samples will be collected and Css_min will be assessed in the part 2 | Up to Days 33 or 57 |
| Part 2: Steady state maximum concentration (Css_max) of SSS17 | Plasma samples will be collected and Css_max will be assessed in the part 2 | Up to Days 33 or 57 |
| Part 2: Steady state average concentration (Css_av) of SSS17 | Plasma samples will be collected and Css_av will be assessed in the part 2 | Up to Days 33 or 57 |
| Part 2: Area under the concentration-time curve of plasma concentration of SSS17 within the interval of administration after reaching steady state (AUC0-τ) | Plasma samples will be collected and the AUC from zero to τ will be assessed | Up to Days 33 or 57 |
| Part 3: Maximum plasma concentration (Cmax) of SSS17 | Plasma samples will be collected and Cmax will be assessed in the part 3 | Up to Days 44 |
| Part 3: Area under the concentration-time curve (AUC) of plasma concentration of SSS17 | Plasma samples will be collected and the AUC from zero to infinity will be assessed in the part 3 | Up to Days 44 |
| Part 3: Time-to-Cmax (Tmax) of SSS 17 | Plasma samples will be collected and the Tmax will be assessed from the concentration-time curve in the part 3 | Up to Days 44 |
| Part 3: Elimination terminal half-life (t1/2) of SSS17 | Plasma samples will be collected and the t1/2 will be assessed in the part 3 | Up to Days 44 |
| Up to 168 hours post-dose |
| Part 1: Change of hepcidin from baseline | Change of serum hepcidin concentrations from baseline following SSS17 in the part 1 | Up to 168 hours post-dose |
| Part 1: Change of RTC from baseline | Change of RTC from baseline following SSS17 in the part 1 | Baseline up to Days 15 |
| Part 1: Change of RBC from baseline | Change of RBC from baseline following SSS17 in the part 1 | Baseline up to Days 15 |
| Part 1: Change of Hgb from baseline | Change of Hgb from baseline following SSS17 in the part 1 | Baseline up to Days 15 |
| Part 2: EPO concentrations | Change of EPO concentrations from baseline following SSS17 in the part 2 | Up to Days 33 or 57 |
| Part 2: VEGF concentrations | Change of VEGF concentrations from baseline following SSS17 in the part 2 | Up to Days 33 or 57 |
| Part 2: Change of hepcidin from baseline | Change of serum hepcidin concentrations from baseline following SSS17 in the part 2 | Up to Days 33 or 57 |
| Part 2: Change of RTC from baseline | Change of RTC from baseline following SSS17 in the part 2 | Baseline up to Days 33 or 57 |
| Part 2: Change of RBC from baseline | Change of RBC from baseline following SSS17 in the part 2 | Baseline up to Days 33 or 57 |
| Part 2: Change of Hgb from baseline | Change of Hgb from baseline following SSS17 in the part 2 | Baseline up to Days 33 or 57 |
| Part 3: AEs | Assessment AEs by frequency and severity in the part 3 | Up to Days 44 |
| Part 3: EPO concentrations | Change of EPO concentrations from baseline following SSS17 in the part 3 | Up to Days 44 |
| Part 3: VEGF concentrations | Change of VEGF concentrations from baseline following SSS17 in the part 3 | Up to Days 44 |
| Part 3: Change of hepcidin from baseline | Change of serum hepcidin concentrations from baseline following SSS17 in the part 3 | Up to Days 44 |
| Part 3: Change of RTC from baseline | Change of RTC from baseline following SSS17 in the part 3 | Baseline up to Days 44 |
| Part 3: Change of RBC from baseline | Change of RBC from baseline following SSS17 in the part 3 | Baseline up to Days 44 |
| Part 3: Change of Hgb from baseline | Change of Hgb from baseline following SSS17 in the part 3 | Baseline up to Days 44 |