Skip to main content
OpenTrials
Completed

NCT Number: NCT04818398

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fibrodysplasia Ossificans Progressiva Muscular Diseases Musculoskeletal Diseases Myositis Myositis Ossificans

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Medical Corporation Heishinkai OPHAC Hospital

Osaka, 532-0003, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DS-6016a

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Number of Participants Reporting Treatment-emergent Adverse Events

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

Secondary outcomes

  1. Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a

    Time frame: 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

  2. Pharmacokinetic Parameter of Time to Reach Maximum Concentration (Tmax) of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a

    Time frame: 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

  3. Pharmacokinetic Parameter of Area Under the Concentration-time Curve of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a

    Time frame: 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.

  4. Pharmacokinetic Parameter of Total Clearance (CL/F) of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a

    Time frame: 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

  5. Pharmacokinetic Parameter of Terminal elimination half-life (t1/2) of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a

    Time frame: 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

  6. Pharmacokinetic Parameter of Volume of Distribution (Vz/F) of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a

    Time frame: 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

  7. Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline)

    Time frame: Day 1 (pre-dose), Day 29 and Day 57 post-dose

    The immunogenicity of DS-6016a will be assessed.

  8. Proportion of Participants Who Have Treatment-emergent ADAs

    Time frame: Day 1 (pre-dose), Day 29 and Day 57 post-dose

    The immunogenicity of DS-6016a will be assessed.

  9. Proportion of Participants Who Have Anti-host Cell Protein (HCP) Antibodies

    Time frame: Day 1 (pre-dose), Day 29 and Day 57 post-dose

    The immunogenicity of DS-6016a will be assessed.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 26, 2021
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.