jRCT2051210123CompletedNot Applicable
Phase I single and multiple ascending dose trial of NTa53, Confirmation of pharmacokinetics and safety of NTa53 in healthy Japanese adult males volunteer for single and repeated dose
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Nitto Medic Co., Ltd.
- Enrollment
- 62
- Primary Endpoint
- -
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- Double Blind
Eligibility Criteria
- Ages
- 20age old over to 45age old under (—)
- Sex
- Male
Inclusion Criteria
- •Healthy Japanese male of 20-45 years of age at the time of the informed consent
- •Judged by the investigator as being eligible at a result of the screening test
- •Other protocol-specified inclusion criteria may apply
Exclusion Criteria
- •History of allergy symptoms such as asthma, atopic dermatitis, etc.
- •Judged by the investigator as being ineligible
- •Other protocol-specified exclusion criteria may apply
Outcomes
Primary Outcomes
-
Pharmacokinetics and safety
Secondary Outcomes
No secondary outcomes reported
Investigators
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