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Status unknownNCT04893187Updated Jan 13, 2022

A Phase 1 Study of SSS17 in Healthy Subjects.

A Phase 1 interventional study of SSS17 and Placebo in Anemia in Chronic Kidney Diseases, sponsored by Shenyang Sunshine Pharmaceutical Co., LTD.. Status unknown at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-13.

Sponsored by Shenyang Sunshine Pharmaceutical Co., LTD. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anemia in Chronic Kidney Diseases
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 76 is close to the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Shenyang Sunshine Pharmaceutical Co., LTD. is the lead sponsor of 39 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    Part 1: Single Dose Escalation SSS17

    Escalating doses of SSS17, single dose administration

    Drug: SSS17

  • Placebo comparator
    Part 1: Single Dose Escalation matching Placebo

    Escalating doses of matching placebo, single dose administration

    Drug: Placebo

  • Experimental
    Part 2: Multiple Dose Escalation SSS17

    Escalating doses of SSS17, multiple dose administration

    Drug: SSS17

  • Placebo comparator
    Part 2: Multiple Dose Escalation matching Placebo

    Escalating doses of matching placebo, multiple dose administration

    Drug: Placebo

  • Experimental
    Part 3: Treatment Sequence 1 (A to B)

    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

  • Experimental
    Part 3: Treatment Sequence 2 (B to A)

    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

  • DrugSSS17

    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.

  • DrugPlacebo

    Matched placebo.

06

What researchers measure

Primary outcomes

  1. Part 1: AEs

    Assessment AEs by frequency and severity in the part 1

    Time frame: Baseline up to Days 15

  2. Part 1: Maximum plasma concentration (Cmax) of SSS17

    Plasma samples will be collected and Cmax will be assessed in the part 1

    Time frame: Up to 336 hours post-dose

  3. 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

    Time frame: Up to 336 hours post-dose

  4. 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

    Time frame: Up to 336 hours post-dose

  5. 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

    Time frame: Up to 336 hours post-dose

  6. 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

    Time frame: Up to 72 hours post-dose

  7. 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

    Time frame: Up to 72 hours post-dose

  8. 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

    Time frame: Up to 72 hours post-dose

  9. Part 2: AEs

    Assessment AEs by frequency and severity in the part 2

    Time frame: Up to Days 33 or 57

  10. 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

    Time frame: Up to Days 33 or 57

  11. 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

    Time frame: Up to Days 33 or 57

  12. 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

    Time frame: Up to Days 33 or 57

  13. 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

    Time frame: Up to Days 33 or 57

  14. Part 3: Maximum plasma concentration (Cmax) of SSS17

    Plasma samples will be collected and Cmax will be assessed in the part 3

    Time frame: Up to Days 44

  15. 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

    Time frame: Up to Days 44

  16. 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

    Time frame: Up to Days 44

  17. 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

    Time frame: Up to Days 44

Secondary outcomes

  1. Part 1: EPO concentrations

    Change of EPO concentrations from baseline following SSS17 in the part 1

    Time frame: Up to 168 hours post-dose

  2. Part 1: VEGF concentrations

    Change of VEGF concentrations from baseline following SSS17 in the part 1

    Time frame: Up to 168 hours post-dose

  3. Part 1: Change of hepcidin from baseline

    Change of serum hepcidin concentrations from baseline following SSS17 in the part 1

    Time frame: Up to 168 hours post-dose

  4. Part 1: Change of RTC from baseline

    Change of RTC from baseline following SSS17 in the part 1

    Time frame: Baseline up to Days 15

  5. Part 1: Change of RBC from baseline

    Change of RBC from baseline following SSS17 in the part 1

    Time frame: Baseline up to Days 15

  6. Part 1: Change of Hgb from baseline

    Change of Hgb from baseline following SSS17 in the part 1

    Time frame: Baseline up to Days 15

  7. Part 2: EPO concentrations

    Change of EPO concentrations from baseline following SSS17 in the part 2

    Time frame: Up to Days 33 or 57

  8. Part 2: VEGF concentrations

    Change of VEGF concentrations from baseline following SSS17 in the part 2

    Time frame: Up to Days 33 or 57

  9. Part 2: Change of hepcidin from baseline

    Change of serum hepcidin concentrations from baseline following SSS17 in the part 2

    Time frame: Up to Days 33 or 57

  10. Part 2: Change of RTC from baseline

    Change of RTC from baseline following SSS17 in the part 2

    Time frame: Baseline up to Days 33 or 57

  11. Part 2: Change of RBC from baseline

    Change of RBC from baseline following SSS17 in the part 2

    Time frame: Baseline up to Days 33 or 57

  12. Part 2: Change of Hgb from baseline

    Change of Hgb from baseline following SSS17 in the part 2

    Time frame: Baseline up to Days 33 or 57

  13. Part 3: AEs

    Assessment AEs by frequency and severity in the part 3

    Time frame: Up to Days 44

  14. Part 3: EPO concentrations

    Change of EPO concentrations from baseline following SSS17 in the part 3

    Time frame: Up to Days 44

  15. Part 3: VEGF concentrations

    Change of VEGF concentrations from baseline following SSS17 in the part 3

    Time frame: Up to Days 44

  16. Part 3: Change of hepcidin from baseline

    Change of serum hepcidin concentrations from baseline following SSS17 in the part 3

    Time frame: Up to Days 44

  17. Part 3: Change of RTC from baseline

    Change of RTC from baseline following SSS17 in the part 3

    Time frame: Baseline up to Days 44

  18. Part 3: Change of RBC from baseline

    Change of RBC from baseline following SSS17 in the part 3

    Time frame: Baseline up to Days 44

  19. Part 3: Change of Hgb from baseline

    Change of Hgb from baseline following SSS17 in the part 3

    Time frame: Baseline up to Days 44

07

Study locations

1 of 1 sites recruiting
  • The Fifth Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong 510700, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04893187
Lead sponsor
Shenyang Sunshine Pharmaceutical Co., LTD.
Collaborators
Fifth Affiliated Hospital of Guangzhou Medical University
Responsible party
Sponsor
First posted
May 19, 2021
Start date
Jul 26, 2021
Primary completion
Dec 31, 2022 (estimated)
Completion
Jun 30, 2023 (estimated)
Last update
Jan 13, 2022

Study contacts

Director Li
Contact
747560265@qq.com
18028886429
Professor Fang, Ph.D
Contact
fygk7000@163.com
13701165926

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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