Status:
UNKNOWN
A Phase I Clinical Study of SSD8432 in Healthy Adult Subjects
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSD8432 in Healthy Adult Subjects
Detailed Description
108 healthy adult subjects (including 72 subjects in Part A to C, 16-24 subjects in Part D, and 8-12 subjects in optional Part E), including both males and females, will be enrolled in the phase I stu...
Eligibility Criteria
Inclusion
- Male subjects' weight ≥ 50 kg, female subjects' weight ≥ 45 kg; body mass index ≥ 19 kg/m2 and ≤ 28 kg/m2.
- Female participants of child-bearing potential must agree to use adequate contraception from screening until 1 months after last dose.
Exclusion
- History of any other acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disorders), or use of medication that, in the opinion of the Principal Investigator, may not suitable for participating in this study.
- Subjects with a history of hematophobia or trypanophobia and unable to tolerate intravenous indwelling needle blood sampling.
- History of dysphagia or any other gastrointestinal disease possibly affecting drug absorption.
- Take special diet and cannot abide by the provided food and corresponding requirements in this study.
- Subject with a history of clinically significant hypersensitivity reactions to the active substance of SSD8432 or ritonavir or to any other components of drug products.
Key Trial Info
Start Date :
April 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT05339646
Start Date
April 7 2022
End Date
December 1 2022
Last Update
April 21 2022
Active Locations (1)
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1
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China, 250014