Status:
COMPLETED
Safety, Tolerability and Pharmacokinetic Study of SC1011 in Healthy Subjects
Lead Sponsor:
Guangzhou JOYO Pharma Co., Ltd
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetic profiles of SC1011 in healthy conditions. The main questions it aims to answer are: Safety and tolerabili...
Detailed Description
This is a single-center, open label study to evaluate the safety，tolerability and pharmacokinetics of multiple administration of Sufenidone (SC1011) tablets conducted in 2 groups. Eight subjects were...
Eligibility Criteria
Inclusion
- Males or females, of any race, between 18 and 45 years of age, inclusive, at Screening.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in as assessed by the Investigator.
- Females will be nonpregnant and nonlactating. Females of childbearing potential and male subjects will agree to use contraception.
- Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
Exclusion
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.
- Alcohol consumption of \> 21 units per week for males and \> 14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL wine), or a positive alcohol breath test at Check-in.
- Any screening laboratory or ECG results are not within the normal reference range and are considered clinically significant.
- Participants who participated in other clinical trials within 3 months prior to administration.
- Blood donation or blood loss exceeding 400 mL within 2 months prior to administration.
- Participants who smoked, drank alcohol, tea, food or drink containing xanthine or caffeine, or had strenuous exercise, or had other factors affecting drug absorption, distribution, metabolism and excretion 2 days before drug administration.
- Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.
Key Trial Info
Start Date :
August 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06135363
Start Date
August 11 2022
End Date
January 14 2023
Last Update
November 18 2023
Active Locations (1)
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1
Shanghai Xuhui District Central Hospital
Shanghai, Shanghai Municipality, China, 200020