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

Daiichi Sankyo

Status and phase: Completed; Phase 1

Conditions: Fibrodysplasia Ossificans Progressiva

Treatments: Drug: Placebo; Drug: DS-6016a

Study type: Interventional

Funder types: Industry

Identifiers

NCT04818398

DS6016-A-J101

jRCT2051200155 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 7 patient groups, including a placebo group

DS-6016a dose level 1

Experimental group

Description:

Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.

Treatment:

Drug: DS-6016a

DS-6016a dose level 2

Experimental group

Description:

Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.

Treatment:

Drug: DS-6016a

DS-6016a dose level 3

Experimental group

Description:

Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.

Treatment:

Drug: DS-6016a

DS-6016a dose level 4

Experimental group

Description:

Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.

Treatment:

Drug: DS-6016a

DS-6016a dose level 5

Experimental group

Description:

Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.

Treatment:

Drug: DS-6016a

DS-6016a dose level 6

Experimental group

Description:

Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.

Treatment:

Drug: DS-6016a

Placebo

Placebo Comparator group

Description:

Participants will be randomized to receive a single, subcutaneous injection of placebo.

Treatment:

Drug: Placebo