臨床研究等提出・公開システム

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

Phase I single and multiple ascending dose trial of NTa53

62

Single ascending dose group 32 participants 100% Japanese male, age 20-39 years, BMI 18.6-23.6 kg/m^2 Multiple ascending dose group 30 participants 100% Japanese male, age 20-38 years, BMI 18.7-24.8 kg/m^2

Single ascending dose trial Enrolled 32, Discontinued 0, Completed 32 Multiple ascending dose trial Enrolled 30, Discontinued 1, Completed 29

Single ascending dose trial Adverse events in 3/32 participants (9.4%), 4 cases Non-serious 4, Serious 0 Multiple ascending dose trial Adverse events in 12/30 participants (40.0%), 18 cases Non-serious 18, Serious 0

Pharmacokinetics In the single ascending dose trial, dose proportionality of plasma NTa53 (Cmax, AUC) was observed at all doses. The multiple ascending dose trial (4 times daily for 7 days) suggested accumulation of NTa53 at all doses. Safety No deaths or other serious or significant adverse events were observed in either the single or multiple ascending dose trials. Ophthalmologic examinations, laboratory tests, vital signs, or standard 12-lead electrocardiograms also revealed no clinically relevant problems.

Pharmacokinetics Although accumulation of NTa53 was suggested in the multiple ascending dose trial, it was not a problem compared to previous studies. Therefore, accumulation by ophthalmic administration is considered to have a minor effect on the incidence of adverse events, but safety issues related to accumulation should be kept in mind in the future. Safety No significant safety concerns were observed in the trial.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2051210123

Mikami Hiroshi

Medical Corporation Heishinkai OPHAC Hospital

4-1-29 Miyahara, Yodogawa-ku, Osaka-shi, Osaka, Japan

hiroshi.mikami@heishinkai.com

Development & Research

Nitto Medic Co., Ltd.

1-14-1 Yasuuchi, Yatsuo-machi, Toyama-city, Toyama, Japan

+81-76-455-3541

clinical@nittomedic.co.jp

Complete

Nov. 20, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

other

- 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

- History of allergy symptoms such as asthma, atopic dermatitis, etc.
- Judged by the investigator as being ineligible
- Other protocol-specified exclusion criteria may apply

Male

Allergic conjunctivitis

Administration of NTa53 or placebo and blood sampling

Pharmacokinetics and safety

+81-6-6395-9000

Nov. 11, 2021

none