A Phase I Clinical Study of SSD8432 in Healthy Adult Subjects

  • STATUS
    Recruiting
  • End date
    Dec 29, 2022
  • participants needed
    108
  • sponsor
    Jiangsu Simcere Pharmaceutical Co., Ltd.
Updated on 29 April 2022
Accepts healthy volunteers

Summary

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

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 study.

This study will include Five parts: SSD8432 single dose and SSD8432 co-administrated with ritonavir (Part A), SSD8432 multiple dose (Part B), SSD8432 co-administrated with ritonavir multiple dose (Part C), SSD8432 co-administered ritonavir single dose in fasting and postprandial states (Part D: assessment of food effects) and optional part (Part E: Assessment of the safety and pharmacokinetics of SSD8432 in white healthy adult subjects)

Details
Condition Healthy Participants
Treatment SSD8432 dose 1~7 and Ritonavir, SSD8432 dose 8~9, SSD8432 dose 10~12 and ritonavir, SSD8432 dose 13 and Ritonavir, SSD8432 dose 14 and Ritonavir
Clinical Study IdentifierNCT05339646
SponsorJiangsu Simcere Pharmaceutical Co., Ltd.
Last Modified on29 April 2022

Eligibility

Yes No Not Sure

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

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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