A Phase I Clinical Study of SSD8432 in Healthy Adult Subjects

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About the study

This is a Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSD8432 in Healthy Adult Subjects
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Male subjects' weight ≥ 50 kg, female subjects' weight ≥ 45 kg; body mass index ≥ 19 kg/m2 and ≤ 28 kg/m2.
  2. Female participants of child-bearing potential must agree to use adequate contraception from screening until 1 months after last dose.

EXCLUSION CRITERIA

Exclusion Criteria:

  1. 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.
  2. Subjects with a history of hematophobia or trypanophobia and unable to tolerate intravenous indwelling needle blood sampling.
  3. History of dysphagia or any other gastrointestinal disease possibly affecting drug absorption.
  4. Take special diet and cannot abide by the provided food and corresponding requirements in this study.
  5. 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.
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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

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