DS-6016a Phase I Study - Single ascending dose study to assess the safety, tolerability, and pharmacokinetics of DS-6016a after subcutaneous injection in healthy Japanese subjects. -

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051200155

Enrollment

Registered

2021-03-12

Start date

2021-04-01

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

Fibrodysplasia ossificans progressiva

Interventions

DS-6016a or Placebo is administered at a single subcutaneous injection into the upper arm, upper part of the thigh, or abdominal wall.

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: Adverse Events, laboratory data, body weight, vital signs, and 12-lead Electrocardiography	—

Secondary

Measure	Time frame
-Plasma pharmacokinetics parameters for DS-6016a -Formation of anti-drug antibody and anti-host cell protein antibody	—

Contacts

Public ContactContact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp+81-3-6225-1111

Outcome results

None listed

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