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A Phase 1 Study of SSS17 in Healthy Subjects.

NCT04893187 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2022-01-13

No results posted yet for this 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.

Conditions

  • Anemia in Chronic Kidney Diseases

Interventions

DRUG

SSS17

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.

DRUG

Placebo

Matched placebo.

Sponsors & Collaborators

  • Fifth Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER

  • Shenyang Sunshine Pharmaceutical Co., LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-26
Primary Completion
2022-12-31
Completion
2023-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04893187 on ClinicalTrials.gov