Anemia in Chronic Kidney Diseases Clinical Trial
Official title:
A Phase 1 Study to Evaluate the Tolerance, Safety, Pharmacokinetics and Pharmacodynamics of Oral Administration of SSS17 in Chinese Healthy Adult Subjects With Single and Multiple Dose Escalation and the Effect of Food on the Pharmacokinetics of SSS17.
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.
| Status | Recruiting |
| Enrollment | 76 |
| Est. completion date | June 30, 2023 |
| Est. primary completion date | December 31, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 45 Years |
| Eligibility | Inclusion Criteria: - Chinese healthy adult subjects aged 18-45 years (including the boundary value) at the time of signing the informed consent were male and female; - In the screening period, the weight of male subjects was more than or equal to 50.0 kg; Female weight = 45.0 kg; Body mass index (BMI) ranged from 19.0 kg / m2 to 26.0 kg / m2 (including boundary value); BMI = weight kg / height m2); - Within 6 months from the date of signing the informed consent to the end of the trial, female subjects agreed to take reliable measures to avoid pregnancy and ensure no birth plan, while male subjects agreed to take reliable measures to avoid pregnancy and ensure no birth plan; - Willing to participate in the study and sign a written informed consent, able to communicate well with the researchers, and agreed to follow the requirements of the trial protocol and follow-up on schedule. Exclusion Criteria: - Participated in other drug clinical trials within 3 months before screening; - Have any clinical history of serious diseases or are suffering from related diseases, including but not limited to digestive system (such as diarrhea, vomiting, inflammatory bowel disease, hemorrhoids, acute gastritis, peptic ulcer, acute and chronic gastrointestinal disorders with obvious digestive and absorption disorders), cardiovascular system, respiratory system, urinary system, musculoskeletal system, endocrine system, gastrointestinal tract diseases, etc Diseases of nervous and mental system, blood system, immune system, etc; A history of any disease or thrombotic disease or vascular malformation that increases the risk of bleeding; Patients with dysphagia; - Allergic constitution, known allergic to test drug ingredients or allergic history to any drug or food (mango, shrimp, crab, lobster, etc.) or pollen allergy history; - Those who smoke more than 5 cigarettes / day or the same amount of tobacco after inquiry, or who can not ban smoking during the trial period; Or alcohol consumption per week is equal to 14 units (1 units 25mL wine Baijiu / 100mL wine / 285mL beer), or those who can not prohibit alcohol during the test period; - Have a history of drug abuse or drug abuse; - Within 6 months, there were fertility planning, sperm donation and egg donation planning; - Patients with lactose intolerance (those who have had diarrhea after drinking milk); - Those who have special requirements for diet and cannot accept unified diet; - Blood donors or massive blood loss (= 400ml), EPO treatment, blood transfusion or use of blood products within 3 months before screening; - Those vaccinated within 8 weeks before screening or during the study period; - There was a history of acupuncture and blood sickness; Or with orthostatic hypotension; - Those who have participated in and used the trial drug;Those who have used any prescription drug, over-the-counter drug, Chinese herbal medicine, vitamins or health care products within 14 days before screening and whose time is less than 5 half-life of the drug or less than 2 weeks (whichever is the longest); - The serum pregnancy test of lactating and pregnant women, or female volunteers of childbearing age was positive; - The results of physical examination, chest X-ray, color Doppler ultrasound, electrocardiogram and laboratory examination were abnormal and clinically significant; Or hemoglobin of male subjects was more than 175.0 g / L; Or hemoglobin of female subjects was more than 150.0 g / L; Or hemoglobin of male and female were less than 113g / L; - Within 48 hours before enrollment, those who took any special diet that affected the absorption, distribution, metabolism and excretion of drugs, including pitaya, mango, grapefruit, lime, carambola or food or drink prepared from them, chocolate, and any food or drink containing caffeine; - Urine drug screening test was positive; - Alcohol breath test was positive within 24 hours before administration; - The researchers think that there are other cases that are not suitable for the trial. |
| Country | Name | City | State |
|---|---|---|---|
| China | The Fifth Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Shenyang Sunshine Pharmaceutical Co., LTD. | The Fifth Affiliated Hospital of Guangzhou Medical University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Part 1: AEs | Assessment AEs by frequency and severity in the part 1 | Baseline up to Days 15 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | Up to 72 hours post-dose | |
| Primary | 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 | |
| Primary | Part 2: AEs | Assessment AEs by frequency and severity in the part 2 | Up to Days 33 or 57 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | Part 2: Area under the concentration-time curve of plasma concentration of SSS17 within the interval of administration after reaching steady state (AUC0-t) | Plasma samples will be collected and the AUC from zero to t will be assessed | Up to Days 33 or 57 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Secondary | Part 1: EPO concentrations | Change of EPO concentrations from baseline following SSS17 in the part 1 | Up to 168 hours post-dose | |
| Secondary | Part 1: VEGF concentrations | Change of VEGF concentrations from baseline following SSS17 in the part 1 | Up to 168 hours post-dose | |
| Secondary | 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 | |
| Secondary | Part 1: Change of RTC from baseline | Change of RTC from baseline following SSS17 in the part 1 | Baseline up to Days 15 | |
| Secondary | Part 1: Change of RBC from baseline | Change of RBC from baseline following SSS17 in the part 1 | Baseline up to Days 15 | |
| Secondary | Part 1: Change of Hgb from baseline | Change of Hgb from baseline following SSS17 in the part 1 | Baseline up to Days 15 | |
| Secondary | Part 2: EPO concentrations | Change of EPO concentrations from baseline following SSS17 in the part 2 | Up to Days 33 or 57 | |
| Secondary | Part 2: VEGF concentrations | Change of VEGF concentrations from baseline following SSS17 in the part 2 | Up to Days 33 or 57 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Part 3: AEs | Assessment AEs by frequency and severity in the part 3 | Up to Days 44 | |
| Secondary | Part 3: EPO concentrations | Change of EPO concentrations from baseline following SSS17 in the part 3 | Up to Days 44 | |
| Secondary | Part 3: VEGF concentrations | Change of VEGF concentrations from baseline following SSS17 in the part 3 | Up to Days 44 | |
| Secondary | Part 3: Change of hepcidin from baseline | Change of serum hepcidin concentrations from baseline following SSS17 in the part 3 | Up to Days 44 | |
| Secondary | Part 3: Change of RTC from baseline | Change of RTC from baseline following SSS17 in the part 3 | Baseline up to Days 44 | |
| Secondary | Part 3: Change of RBC from baseline | Change of RBC from baseline following SSS17 in the part 3 | Baseline up to Days 44 | |
| Secondary | Part 3: Change of Hgb from baseline | Change of Hgb from baseline following SSS17 in the part 3 | Baseline up to Days 44 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT04317833 -
A Study of SSS17 in Healthy Subjects
|
Phase 1 |