Phase I single and multiple ascending dose trial of NTa53

JRCT ID: jRCT2051210123

Registered date:24/11/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Allergic conjunctivitis
• Date of first enrollment: 20/11/2021
• Target sample size: 62
• Study type: Interventional
• Intervention(s): Administration of NTa53 or placebo and blood sampling

Outcome(s)

• Primary Outcome: Pharmacokinetics and safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 45age old
• Gender: Male

Include 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

Exclude 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

Related Information

• Primary Sponsor: Mikami Hiroshi