Status:
UNKNOWN
A Study of SSS17 in Healthy Subjects
Lead Sponsor:
Shenyang Sunshine Pharmaceutical Co., LTD.
Conditions:
Anemia in Chronic Kidney Diseases
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 admini...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04317833
Start Date
May 1 2020
End Date
December 31 2021
Last Update
March 23 2020
Active Locations (1)
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1
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China, 201203