NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2051200153

Registered date:12/03/2021

A Phase 1, single-dose and multiple-dose study of DS-2319b inhalation powder to assess the safety and pharmacokinetics of DS-2319a in healthy Japanese subjects

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedSARS-CoV-2 Infectious Disease
Date of first enrollment11/03/2021
Target sample size76
Countries of recruitment
Study typeInterventional
Intervention(s)10 to 120 mg of DS-2319b or Placebo is administered at a single inhalation, or an appropriate dose of DS-2319b within the dose range as stated above or Placebo is administered at multiple inhalation.

Outcome(s)

Primary OutcomeSafety:AEs, laboratory data, body weight, vital signs, 12-lead ECGs, and chest X-ray
Secondary OutcomePK:Concentration of plasma DS-2319a and PK parameters for plasma DS-2319a

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 45age old
GenderMale
Include criteria1. Japanese healthy male subjects. 2. Age >=20 and <=45 years upon providing informed consent. 3. Body mass index (BMI) >=18.5 and <25.0 kg/m2 at screening.
Exclude criteria1. Having a history of hypersensitivity to any drugs or substances, or being idiosyncratic (eg, having penicillin allergy) 2. Having alcohol or drug dependence etc.

Related Information

Contact

Public contact
Name Contact for Clinical Trial Information
Address 1-2-58, Hiromachi, Shinagawa-ku, Tokyo Tokyo Japan 140-8710
Telephone +81-3-6225-1111
E-mail dsclinicaltrial@daiichisankyo.co.jp
Affiliation DAIICHI SANKYO Co.,Ltd.
Scientific contact
Name Akihiro Inoguchi
Address 1-2-58, Hiromachi, Shinagawa-ku, Tokyo Tokyo Japan 140-8710
Telephone +81-3-6225-1111
E-mail dsclinicaltrial@daiichisankyo.co.jp
Affiliation DAIICHI SANKYO Co.,Ltd.