A Study of SSS17 in Healthy Subjects

• Status: Not yet recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.

Criteria

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