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. -

JRCT ID: jRCT2051200155

Registered date:12/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Fibrodysplasia ossificans progressiva
• Date of first enrollment: 01/04/2021
• Target sample size: 48
• Study type: Interventional
• Intervention(s): DS-6016a or Placebo is administered at a single subcutaneous injection into the upper arm, upper part of the thigh, or abdominal wall.

Outcome(s)

Primary Outcome

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

Secondary Outcome

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

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
• Source(s) of Monetary Support: Japan Agency for Medical and Development
• Secondary ID(s): NCT04818398