CompletedPhase 1

Study of Single-Ascending Doses of DS-6016a in Healthy Japanese Subjects

Japan48 participantsStarted 2021-04-01

Plain-language summary

This study will assess the safety, tolerability, and pharmacokinetics of DS-6016a after subcutaneous injection in healthy Japanese participants.

Who can participate

Age range20 Years – 45 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Japanese healthy male subjects. * Age ≥20 and ≤45 years upon providing informed consent. * Body mass index (BMI) ≥18.5 and \<25.0 kg/m\^2 at screening. Exclusion Criteria: * Have a history of hypersensitivity to any drugs or substances, or being idiosyncratic (eg, having penicillin allergy) * Have alcohol or drug dependence, etc.

What they're measuring

Number of Participants Reporting Treatment-emergent Adverse Events

Timeframe: Day 1 through end of study, up to 8 weeks post-dose

Trial details

NCT IDNCT04818398

SponsorDaiichi Sankyo Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12-24

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