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A Study of SSS17 in Healthy Subjects

Primary Purpose

Anemia in Chronic Kidney Diseases

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

SSS17

Placebo

About this trial

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

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Body weight≥50 for male or ≥45 for female, and BMI between 19.0-26.0 kg/m2
Good general health as determined by the investigator based on medical history, physical examination, vital signs, 12-lead ECG, clinical laboratory tests and B-type ultrasound test.
Participants of reproductive potential must agree to utilize reliable methods of contraception from screening to 6 months after the last administration of the study intervention. No plan for sperm (or egg) donation or pregnancy.
Understand and sign the informed consent.
Ability to understand and follow study-related instruction

Exclusion Criteria:

A known allergy to any component of the SSS17 formulation, or allergy history of two kinds of drugs or food
Medical history or conditions of digestive system.
Female volunteers who are pregnant, menstrual, lactating or menopause with hormone therapy.
Eyes diseases, including diabetic retinopathy, age-related macular degeneration.
Vascular anomalies.
Drug, alcohol or nicotine addiction.
Blood donation or bleeding (more than 200 ml). Experience of treatment with EPO or blood transfusion.
Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) deviating from normal and deemed by the investigator to be of clinical relevance
Abnormal results in test of TIBC, serum iron or ferritin
Acute diseases before administration.
Other situations that the researcher believes may affect validity judgment or are not suitable for participation

Sites / Locations

Shanghai Public Health Clinical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dose Escalation SSS17

Escalation matching Placebo

Arm Description

Escalating doses of SSS17; single dose administration; different dosage forms (redosing of the SSS17 in one cohort with food on Day15)

Escalating doses of matching placebo; single dose administration; different dosage forms (redosing of matching placebo in one cohort with food on Day15)

Outcomes

Primary Outcome Measures

AEs

assessment AEs by frequency, severity

Secondary Outcome Measures

Maximum plasma concentration (Cmax) of SSS17

Plasma samples will be collected and Cmax will be assessed.

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.

Time-to-Cmax (Tmax) of SSS 17

Plasma samples will be collected and the Tmax will be assessed from the concentration-time curve.

Elimination terminal half-life (t1/2) of SSS17

Plasma samples will be collected and the t1/2 will be assessed.

Total amount of SSS17 excreted in urine over 24 hours (Ae0-24)

Urine sample will be collected at pre-specified intervals and Ae0-24 will be assessed.

Fraction of SSS17 excretion during each collection interval (Fe0-24)

Urine sample will be collected at pre-specified intervals and Fe0-24 will be assessed.

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.

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.

Renal clearance (CLR) of SSS17

Urine sample will be collected at pre-specified intervals and CLR will be assessed.

EPO concentrations

Change of EPO concentrations from baseline following SSS17

VEGF concentrations

Change of VEGF concentrations from baseline following SSS17

Change of RTC from baseline

Change of RTC from baseline following SSS17

Change of RBC from baseline

Change of RBC from baseline following SSS17

Change of Hgb from baseline

Change of Hgb from baseline following SSS17

Change of hepcidin from baseline

Change of serum hepcidin concentrations from baseline following SSS17

Full Information

NCT ID

NCT04317833

First Posted

March 19, 2020

Last Updated

March 20, 2020

Sponsor

Shenyang Sunshine Pharmaceutical Co., LTD.

1. Study Identification

Unique Protocol Identification Number

NCT04317833

Brief Title

A Study of SSS17 in Healthy Subjects

Official Title

A Single Dose Escalation Study to Investigate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of SSS17 in Chinese Healthy Subject

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2020 (Anticipated)

Primary Completion Date

June 30, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shenyang Sunshine Pharmaceutical Co., LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a first-in-human, Phase 1, single-center, randomized, single-blind, placebo-controlled, single dose-escalation study to evaluate the safety, tolerability, PK, PD of SSS17 following oral administration in healthy subjects. Approximately 65 subjects (53 receiving active drug and 12 receiving placebo) will participate in this study.

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 improved Fibonacci dose escalation design will be implemented. The protocol specifies 10 mg, oral, one time for the first cohort without placebo control. Successive cohorts will be given doses up to 540 mg with placebo parallel control. Only no observation meets the criteria under stop rules, dose will escalate to the next higher level. The study will be divided into 2 stages: 1st period (fast) and 2nd period(fed). First period (fast): Subjects will be allocated 1:4 to receive placebo or SSS17, which will be administered by oral route. At each dose, tolerability, safety, PK and PD characteristics will be investigated. Second period (fed): in order to investigate the effects of food on PK and PD of SSS17. Subjects in one cohort will be administered again after meal on Day15. The accurate dose will be adjusted according to the findings in 1st period (fast)

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

65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dose Escalation SSS17

Arm Type

Experimental

Arm Description

Escalating doses of SSS17; single dose administration; different dosage forms (redosing of the SSS17 in one cohort with food on Day15)

Arm Title

Escalation matching Placebo

Arm Type

Placebo Comparator

Arm Description

Escalating doses of matching placebo; single dose administration; different dosage forms (redosing of matching placebo in one cohort with food on Day15)

Intervention Type

Drug

Intervention Name(s)

SSS17

Intervention Description

SSS17 is a novel small molecule compound which stimulates erythropoiesis through inhibition of hypoxia-inducible 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

AEs

Description

assessment AEs by frequency, severity

Time Frame

up to Day14 or 29

Secondary Outcome Measure Information:

Title

Maximum plasma concentration (Cmax) of SSS17

Description

Plasma samples will be collected and Cmax will be assessed.

Time Frame

[ up to 48 hours post-dose]

Title

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.

Time Frame

[ up to 48 hours post-dose]

Title

Time-to-Cmax (Tmax) of SSS 17

Description

Plasma samples will be collected and the Tmax will be assessed from the concentration-time curve.

Time Frame

[ up to 48 hours post-dose]

Title

Elimination terminal half-life (t1/2) of SSS17

Description

Plasma samples will be collected and the t1/2 will be assessed.

Time Frame

[up to 48 hours post-dose]

Title

Total amount of SSS17 excreted in urine over 24 hours (Ae0-24)

Description

Urine sample will be collected at pre-specified intervals and Ae0-24 will be assessed.

Time Frame