A Phase I Clinical Study of SSD8432 in Healthy Adult Subjects
About the study
This is a Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSD8432 in Healthy Adult Subjects
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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 CRITERIA
Exclusion Criteria:
- 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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Healthy Participants
Age (in years)
18 - 55
Phase
Phase 1
Participants needed
108
Est. Completion Date
Dec 31, 2022
Treatment type
Interventional
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov identifier
NCT05339646
Study number
B02B11101-101
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?