A Phase 1 Study of SSS17 in Healthy Subjects.

NCT04893187 | Unknown Phase 1 DMC

• 1 other identifier: SYSS-SSS17-UND-I-02
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia in Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (17)

• 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

  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

Secondary Outcomes (19)

• Part 1: EPO concentrations

  Up to 168 hours post-dose

• Part 1: VEGF concentrations

  Up to 168 hours post-dose

• Part 1: Change of hepcidin from baseline

  Up to 168 hours post-dose

• Part 1: Change of RTC from baseline

  Baseline up to Days 15

• Part 1: Change of RBC from baseline

  Baseline up to Days 15

Study Arms (6)

Part 1: Single Dose Escalation SSS17

EXPERIMENTAL

Escalating doses of SSS17, single dose administration

Drug: SSS17

Part 1: Single Dose Escalation matching Placebo

PLACEBO COMPARATOR

Escalating doses of matching placebo, single dose administration

Drug: Placebo

Part 2: Multiple Dose Escalation SSS17

EXPERIMENTAL

Escalating doses of SSS17, multiple dose administration

Drug: SSS17

Part 2: Multiple Dose Escalation matching Placebo

PLACEBO COMPARATOR

Escalating doses of matching placebo, multiple dose administration

Drug: Placebo

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

Drug: SSS17

Part 3: Treatment Sequence 2 (B to A)

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

Drug: SSS17

Interventions

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.

Part 1: Single Dose Escalation SSS17; Part 2: Multiple Dose Escalation SSS17; Part 3: Treatment Sequence 1 (A to B); Part 3: Treatment Sequence 2 (B to A)

Placebo DRUG

Matched placebo.

Part 1: Single Dose Escalation matching Placebo; Part 2: Multiple Dose Escalation matching Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead
• Fifth Affiliated Hospital of Guangzhou Medical University: collaborator

Study Sites (1)

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510700, China

RECRUITING

Central Study Contacts

Director Li

CONTACT

18028886429; 747560265@qq.com

Professor Fang, Ph.D

CONTACT

13701165926; fygk7000@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 19, 2021
• Study Start: July 26, 2021
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: January 13, 2022

Record last verified: 2021-12

Locations

CN (1)