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Clinical Trials/jRCT2031220579
jRCT2031220579CompletedNot Applicable

A Phase 1 Study of Apraglutide (Single Dose Study)

Asahi Kasei Pharma Corporation0 sites36 target enrollmentStarted: March 11, 2023Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Primary Endpoint
-
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomized Controlled Trial
Intervention Model
Parallel Assignment
Primary Purpose
Treatment Purpose
Masking
Double Blind

Eligibility Criteria

Ages
18age old over to 45age old not (—)
Sex
All

Inclusion Criteria

  • •The subjects will be individuals who meet all of the following criteria.
  • •[1] Healthy Japanese men and women
  • •[2] Individuals >=18 to <45 years of age at the time of informed consent
  • •[3] Individuals who fully understand the details of the study and who are capable of providing written informed consent

Exclusion Criteria

  • •Individuals meeting any of the following criteria will be excluded from the study.
  • •[1] Past history of disease in organsystems considered unsuitable for this study
  • •[2] Past history of disease or surgery that could affect pharmacokinetic or pharmacodynamic evaluation
  • •[3] Other protocol defined exclusion criteria could apply

Outcomes

Primary Outcomes

-

Plasma concentration of compound(s)

Secondary Outcomes

No secondary outcomes reported

Investigators

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