A Phase I Study of TS-172 in Healthy Adult Subjects (Single and Multiple Doses)

  • STATUS
    Recruiting
  • days left to enroll
    64
  • participants needed
    41
  • sponsor
    Taisho Pharmaceutical Co., Ltd.
Updated on 1 September 2021

Summary

A Phase 1, Single-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending and Multiple Dose of TS-172 in Healthy Adult Subjects

Details
Condition Healthy Adult Subjects
Treatment Placebo, TS-172
Clinical Study IdentifierNCT04979572
SponsorTaisho Pharmaceutical Co., Ltd.
Last Modified on1 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Japanese healthy males aged 20 years or older but less than 40 years at the time of informed consent
Those with a BMI of 18.5 or more and less than 25.0 at screening test
Those who are able to receive the explanation before participating in the study, understand the content of the study, and provide written informed consent by the subjects themselves

Exclusion Criteria

Subjects who have any disease and are not considered healthy subjects based on the medical judgment of the principal investigator or sub-investigator
Those who correspond to any of the following about bowel movements
Repeated diarrhea (Bristol Stool Form Score [BSFS] score of 6 or higher) on a daily basis
Repeated constipation (no defecation for 2 days or more in a week) on a daily basis
Those who correspond to any of the following about bowel movements in the 7 days before administration
Diarrhea on 2 or more days in 7 days
or more days without a bowel movement in 7 days
Those who have a history of gastrointestinal ulceration
Those who correspond to any of the following about infection
Positive for SARS-CoV-2 in the nucleic acid amplification test performed at the time of admission
Suspected of having COVID-19
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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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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