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A Phase 1 Study of SSS17 in Healthy Subjects.

Primary Purpose

Anemia in Chronic Kidney Diseases

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SSS17
Placebo
Sponsored by
Shenyang Sunshine Pharmaceutical Co., LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia in Chronic Kidney Diseases

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The Fifth Affiliated Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Part 1: Single Dose Escalation SSS17

Part 1: Single Dose Escalation matching Placebo

Part 2: Multiple Dose Escalation SSS17

Part 2: Multiple Dose Escalation matching Placebo

Part 3: Treatment Sequence 1 (A to B)

Part 3: Treatment Sequence 2 (B to A)

Arm Description

Escalating doses of SSS17, single dose administration

Escalating doses of matching placebo, single dose administration

Escalating doses of SSS17, multiple dose administration

Escalating doses of matching placebo, multiple dose administration

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

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

Outcomes

Primary Outcome Measures

Part 1: AEs
Assessment AEs by frequency and severity in the part 1
Part 1: Maximum plasma concentration (Cmax) of SSS17
Plasma samples will be collected and Cmax will be assessed in the part 1
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
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
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
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
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
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
Part 2: AEs
Assessment AEs by frequency and severity in the part 2
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
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
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
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
Part 3: Maximum plasma concentration (Cmax) of SSS17
Plasma samples will be collected and Cmax will be assessed in the part 3
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
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
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

Secondary Outcome Measures

Part 1: EPO concentrations
Change of EPO concentrations from baseline following SSS17 in the part 1
Part 1: VEGF concentrations
Change of VEGF concentrations from baseline following SSS17 in the part 1
Part 1: Change of hepcidin from baseline
Change of serum hepcidin concentrations from baseline following SSS17 in the part 1
Part 1: Change of RTC from baseline
Change of RTC from baseline following SSS17 in the part 1
Part 1: Change of RBC from baseline
Change of RBC from baseline following SSS17 in the part 1
Part 1: Change of Hgb from baseline
Change of Hgb from baseline following SSS17 in the part 1
Part 2: EPO concentrations
Change of EPO concentrations from baseline following SSS17 in the part 2
Part 2: VEGF concentrations
Change of VEGF concentrations from baseline following SSS17 in the part 2
Part 2: Change of hepcidin from baseline
Change of serum hepcidin concentrations from baseline following SSS17 in the part 2
Part 2: Change of RTC from baseline
Change of RTC from baseline following SSS17 in the part 2
Part 2: Change of RBC from baseline
Change of RBC from baseline following SSS17 in the part 2
Part 2: Change of Hgb from baseline
Change of Hgb from baseline following SSS17 in the part 2
Part 3: AEs
Assessment AEs by frequency and severity in the part 3
Part 3: EPO concentrations
Change of EPO concentrations from baseline following SSS17 in the part 3
Part 3: VEGF concentrations
Change of VEGF concentrations from baseline following SSS17 in the part 3
Part 3: Change of hepcidin from baseline
Change of serum hepcidin concentrations from baseline following SSS17 in the part 3
Part 3: Change of RTC from baseline
Change of RTC from baseline following SSS17 in the part 3
Part 3: Change of RBC from baseline
Change of RBC from baseline following SSS17 in the part 3
Part 3: Change of Hgb from baseline
Change of Hgb from baseline following SSS17 in the part 3

Full Information

First Posted
May 17, 2021
Last Updated
December 27, 2021
Sponsor
Shenyang Sunshine Pharmaceutical Co., LTD.
Collaborators
Fifth Affiliated Hospital of Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04893187
Brief Title
A Phase 1 Study of SSS17 in Healthy Subjects.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenyang Sunshine Pharmaceutical Co., LTD.
Collaborators
Fifth Affiliated Hospital of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia in Chronic Kidney Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Single Dose Escalation SSS17
Arm Type
Experimental
Arm Description
Escalating doses of SSS17, single dose administration
Arm Title
Part 1: Single Dose Escalation matching Placebo
Arm Type
Placebo Comparator
Arm Description
Escalating doses of matching placebo, single dose administration
Arm Title
Part 2: Multiple Dose Escalation SSS17
Arm Type
Experimental
Arm Description
Escalating doses of SSS17, multiple dose administration
Arm Title
Part 2: Multiple Dose Escalation matching Placebo
Arm Type
Placebo Comparator
Arm Description
Escalating doses of matching placebo, multiple dose administration
Arm Title
Part 3: Treatment Sequence 1 (A to B)
Arm Type
Experimental
Arm Description
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
Arm Title
Part 3: Treatment Sequence 2 (B to A)
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
SSS17
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched placebo.
Primary Outcome Measure Information:
Title
Part 1: AEs
Description
Assessment AEs by frequency and severity in the part 1
Time Frame
Baseline up to Days 15
Title
Part 1: Maximum plasma concentration (Cmax) of SSS17
Description
Plasma samples will be collected and Cmax will be assessed in the part 1
Time Frame
Up to 336 hours post-dose
Title
Part 1: Area under the concentration-time curve (AUC) of plasma concentration of SSS17
Description
Plasma samples will be collected and the AUC from zero to infinity will be assessed in the part 1
Time Frame
Up to 336 hours post-dose
Title
Part 1: Time-to-Cmax (Tmax) of SSS 17
Description
Plasma samples will be collected and the Tmax will be assessed from the concentration-time curve in the part 1
Time Frame
Up to 336 hours post-dose
Title
Part 1: Elimination terminal half-life (t1/2) of SSS17
Description
Plasma samples will be collected and the t1/2 will be assessed in the part 1
Time Frame
Up to 336 hours post-dose
Title
Part 1: . Total amount of SSS17 excreted in urine over 72 hours (Ae0-72)
Description
Urine sample will be collected at pre-specified intervals and Ae0-72 will be assessed in the part 1
Time Frame
Up to 72 hours post-dose
Title
Part 1: Fraction of SSS17 excretion during each collection interval (Fe0-72)
Description
Urine sample will be collected at pre-specified intervals and Fe0-72 will be assessed in the part 1
Time Frame
Up to 72 hours post-dose
Title
Part 1: Renal clearance (CLR) of SSS17
Description
Urine sample will be collected at pre-specified intervals and CLR will be assessed in the part 1
Time Frame
Up to 72 hours post-dose
Title
Part 2: AEs
Description
Assessment AEs by frequency and severity in the part 2
Time Frame
Up to Days 33 or 57
Title
Part 2: Steady state minimal concentration (Css_min) of SSS17
Description
Plasma samples will be collected and Css_min will be assessed in the part 2
Time Frame
Up to Days 33 or 57
Title
Part 2: Steady state maximum concentration (Css_max) of SSS17
Description
Plasma samples will be collected and Css_max will be assessed in the part 2
Time Frame
Up to Days 33 or 57
Title
Part 2: Steady state average concentration (Css_av) of SSS17
Description
Plasma samples will be collected and Css_av will be assessed in the part 2
Time Frame
Up to Days 33 or 57
Title
Part 2: Area under the concentration-time curve of plasma concentration of SSS17 within the interval of administration after reaching steady state (AUC0-τ)
Description
Plasma samples will be collected and the AUC from zero to τ will be assessed
Time Frame
Up to Days 33 or 57
Title
Part 3: Maximum plasma concentration (Cmax) of SSS17
Description
Plasma samples will be collected and Cmax will be assessed in the part 3
Time Frame
Up to Days 44
Title
Part 3: Area under the concentration-time curve (AUC) of plasma concentration of SSS17
Description
Plasma samples will be collected and the AUC from zero to infinity will be assessed in the part 3
Time Frame
Up to Days 44
Title
Part 3: Time-to-Cmax (Tmax) of SSS 17
Description
Plasma samples will be collected and the Tmax will be assessed from the concentration-time curve in the part 3
Time Frame
Up to Days 44
Title
Part 3: Elimination terminal half-life (t1/2) of SSS17
Description
Plasma samples will be collected and the t1/2 will be assessed in the part 3
Time Frame
Up to Days 44
Secondary Outcome Measure Information:
Title
Part 1: EPO concentrations
Description
Change of EPO concentrations from baseline following SSS17 in the part 1
Time Frame
Up to 168 hours post-dose
Title
Part 1: VEGF concentrations
Description
Change of VEGF concentrations from baseline following SSS17 in the part 1
Time Frame
Up to 168 hours post-dose
Title
Part 1: Change of hepcidin from baseline
Description
Change of serum hepcidin concentrations from baseline following SSS17 in the part 1
Time Frame
Up to 168 hours post-dose
Title
Part 1: Change of RTC from baseline
Description
Change of RTC from baseline following SSS17 in the part 1
Time Frame
Baseline up to Days 15
Title
Part 1: Change of RBC from baseline
Description
Change of RBC from baseline following SSS17 in the part 1
Time Frame
Baseline up to Days 15
Title
Part 1: Change of Hgb from baseline
Description
Change of Hgb from baseline following SSS17 in the part 1
Time Frame
Baseline up to Days 15
Title
Part 2: EPO concentrations
Description
Change of EPO concentrations from baseline following SSS17 in the part 2
Time Frame
Up to Days 33 or 57
Title
Part 2: VEGF concentrations
Description
Change of VEGF concentrations from baseline following SSS17 in the part 2
Time Frame
Up to Days 33 or 57
Title
Part 2: Change of hepcidin from baseline
Description
Change of serum hepcidin concentrations from baseline following SSS17 in the part 2
Time Frame
Up to Days 33 or 57
Title
Part 2: Change of RTC from baseline
Description
Change of RTC from baseline following SSS17 in the part 2
Time Frame
Baseline up to Days 33 or 57
Title
Part 2: Change of RBC from baseline
Description
Change of RBC from baseline following SSS17 in the part 2
Time Frame
Baseline up to Days 33 or 57
Title
Part 2: Change of Hgb from baseline
Description
Change of Hgb from baseline following SSS17 in the part 2
Time Frame
Baseline up to Days 33 or 57
Title
Part 3: AEs
Description
Assessment AEs by frequency and severity in the part 3
Time Frame
Up to Days 44
Title
Part 3: EPO concentrations
Description
Change of EPO concentrations from baseline following SSS17 in the part 3
Time Frame
Up to Days 44
Title
Part 3: VEGF concentrations
Description
Change of VEGF concentrations from baseline following SSS17 in the part 3
Time Frame
Up to Days 44
Title
Part 3: Change of hepcidin from baseline
Description
Change of serum hepcidin concentrations from baseline following SSS17 in the part 3
Time Frame
Up to Days 44
Title
Part 3: Change of RTC from baseline
Description
Change of RTC from baseline following SSS17 in the part 3
Time Frame
Baseline up to Days 44
Title
Part 3: Change of RBC from baseline
Description
Change of RBC from baseline following SSS17 in the part 3
Time Frame
Baseline up to Days 44
Title
Part 3: Change of Hgb from baseline
Description
Change of Hgb from baseline following SSS17 in the part 3
Time Frame
Baseline up to Days 44

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Director Li
Phone
18028886429
Email
747560265@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Professor Fang, Ph.D
Phone
13701165926
Email
fygk7000@163.com
Facility Information:
Facility Name
The Fifth Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510700
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Fang, Ph.D
Phone
13701165926
Email
fygk7000@163.com
First Name & Middle Initial & Last Name & Degree
Yongmei Li, Ph.D
Phone
13640691018
Email
Liyongmei_gz@126.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Phase 1 Study of SSS17 in Healthy Subjects.

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