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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)

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

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The mean age was 23.8 years to 28.0 years, the mean body weight was 60.68 kg to 65.87 kg, and the mean BMI was 20.23 to 21.83 kg/m^2. No notable differences were found in the demographic or other baseline characteristics among the administration groups.

The study was terminated after cohort 3. Within each cohort, 6 participants were allocated to receive DS-2319b and 2 participants to receive placebo (24 participants in total), and all participants completed the study. All of the 24 randomized participants were included in the safety analysis set. 18 participants who received DS-2319b were included in the pharmacokinetic analysis set.

Treatment-emergent adverse events (TEAEs) and adverse drug reactions occurred in all participants who received DS-2319b. However, there were no serious adverse events and no TEAEs leading to study drug discontinuation. All participants (18/18 patients) who received DS-2319b occurred cough, and 5 participants occurred oropharyngeal pain (1/6 patients in 10 mg group: 16.7%, 1/6 patients in 20 mg group: 16.7%, 3/6 patients in 40 mg group: 50%). Except for laboratory changes reported as TEAEs, no clinically meaningful changes were observed in laboratory parameters, vital signs, body weight, and 12-induced ECG.

<Primary outcome> - Safety: Please refer to "Adverse events" section since primary outcome in the study is safety. <Secondary outcome> - Pharmacokinetics: Cmax, AUClast and AUCinf of DS-2319a increased as the dose of DS-2319b increased. Tmax of plasma DS-2319a was 0.25 h and t1/2 was approximately 2 to 5 h.

The study was terminated after cohort 3. When DS-2319b 10 mg, 20 mg or 40 mg was administered as a single inhaled dose to healthy Japanese adult male, cough occurred in all of them. However, there were no serious adverse events and no TEAEs leading to study drug discontinuation. Tmax of plasma DS-2319a was 0.25 h and t1/2 was approximately 2 to 5 h. Cmax, AUClast and AUCinf of DS-2319a increased as the dose of DS-2319b increased.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2051200153

Inoguchi Akihiro

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

dsclinicaltrial_jp@daiichisankyo.com

Contact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial_jp@daiichisankyo.com

Complete

Mar. 10, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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.

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.

Male

SARS-CoV-2 Infectious Disease

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.

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

PK:Concentration of plasma DS-2319a and PK parameters for plasma DS-2319a

+81-6-6395-9000

Mar. 09, 2021

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