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

Single-Ascending Dose Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-6016a After Subcutaneous Injection in Healthy Japanese Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04818398

Enrollment

Registered

2021-03-26

Start date

2021-04-01

Completion date

2022-07-26

Last updated

2022-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibrodysplasia Ossificans Progressiva

Keywords

Fibrodysplasia Ossificans Progressiva, Bone Morphogenetic Protein, Activin Receptor-like Kinase-2

Brief summary

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

Interventions

DRUGDS-6016a

DS-6016a will be administered as a single subcutaneous injection into the upper arm, upper part of the thigh, or abdominal wall

DRUGPlacebo

Placebo will be administered as a single subcutaneous injection into the upper arm, upper part of the thigh, or abdominal wall

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Number of Participants Reporting Treatment-emergent Adverse Events	Day 1 through end of study, up to 8 weeks post-dose

Secondary

Measure	Time frame	Description
Pharmacokinetic Parameter of Terminal elimination half-life (t1/2) of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a	Day 1 (pre-dose, 2 and 8 hours after the start of administration), Day 2 (24 and 36 hours after the start of administration), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 12, Day 15, Day 18, Day 22, Day 29, Day 36, Day 43, Day 57	—
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a	Day 1 (pre-dose, 2 and 8 hours after the start of administration), Day 2 (24 and 36 hours after the start of administration), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 12, Day 15, Day 18, Day 22, Day 29, Day 36, Day 43, Day 57	—
Pharmacokinetic Parameter of Time to Reach Maximum Concentration (Tmax) of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a	Day 1 (pre-dose, 2 and 8 hours after the start of administration), Day 2 (24 and 36 hours after the start of administration), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 12, Day 15, Day 18, Day 22, Day 29, Day 36, Day 43, Day 57	—
Pharmacokinetic Parameter of Area Under the Concentration-time Curve of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a	Day 1 (pre-dose, 2 and 8 hours after the start of administration), Day 2 (24 and 36 hours after the start of administration), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 12, Day 15, Day 18, Day 22, Day 29, Day 36, Day 43, Day 57	Area under the concentration-time curve from time 0 to last measurable time point (AUClast), time 0 to 336h (AUC336h), and time 0 to infinity (AUCinf) will be assessed.
Pharmacokinetic Parameter of Total Clearance (CL/F) of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a	Day 1 (pre-dose, 2 and 8 hours after the start of administration), Day 2 (24 and 36 hours after the start of administration), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 12, Day 15, Day 18, Day 22, Day 29, Day 36, Day 43, Day 57	—
Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline)	Day 1 (pre-dose), Day 29 and Day 57 post-dose	The immunogenicity of DS-6016a will be assessed.
Proportion of Participants Who Have Treatment-emergent ADAs	Day 1 (pre-dose), Day 29 and Day 57 post-dose	The immunogenicity of DS-6016a will be assessed.
Proportion of Participants Who Have Anti-host Cell Protein (HCP) Antibodies	Day 1 (pre-dose), Day 29 and Day 57 post-dose	The immunogenicity of DS-6016a will be assessed.
Pharmacokinetic Parameter of Volume of Distribution (Vz/F) of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a	Day 1 (pre-dose, 2 and 8 hours after the start of administration), Day 2 (24 and 36 hours after the start of administration), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 12, Day 15, Day 18, Day 22, Day 29, Day 36, Day 43, Day 57	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026