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

JRCT ID: jRCT2051200153

Registered date:12/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: SARS-CoV-2 Infectious Disease
• Date of first enrollment: 11/03/2021
• Target sample size: 76
• Study type: Interventional
• 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 Outcome: Safety:AEs, laboratory data, body weight, vital signs, 12-lead ECGs, and chest X-ray
• Secondary Outcome: PK:Concentration of plasma DS-2319a and PK parameters for plasma DS-2319a

Key inclusion & exclusion criteria

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

Include criteria

1. 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 criteria

1. 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

• Primary Sponsor: Inoguchi Akihiro