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

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 (COVID-19)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051200153

Enrollment

Registered

2021-03-12

Start date

2021-03-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV-2 Infectious Disease

Interventions

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.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Japanese healthy male subjects. 2. Age >=20 and =18.5 and <25.0 kg/m2 at screening.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Safety:AEs, laboratory data, body weight, vital signs, 12-lead ECGs, and chest X-ray	—

Secondary

Measure	Time frame
PK:Concentration of plasma DS-2319a and PK parameters for plasma DS-2319a	—

Contacts

Public ContactContact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial_jp@daiichisankyo.com+81-3-6225-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026