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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2051200155 | Other Identifier | Japan Registry of Clinical Trial |
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This study will assess the safety, tolerability, and pharmacokinetics of DS-6016a after subcutaneous injection in healthy Japanese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DS-6016a dose level 1 | Experimental | Participants will be randomized to receive a single, subcutaneous injection of DS-6016a. |
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| DS-6016a dose level 2 | Experimental | Participants will be randomized to receive a single, subcutaneous injection of DS-6016a. |
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| DS-6016a dose level 3 | Experimental | Participants will be randomized to receive a single, subcutaneous injection of DS-6016a. |
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| DS-6016a dose level 4 | Experimental | Participants will be randomized to receive a single, subcutaneous injection of DS-6016a. |
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| DS-6016a dose level 5 | Experimental | Participants will be randomized to receive a single, subcutaneous injection of DS-6016a. |
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| DS-6016a dose level 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Treatment-emergent Adverse Events | Day 1 through end of study, up to 8 weeks post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Corporation Heishinkai OPHAC Hospital | Osaka | 532-0003 | Japan |
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
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| ID | Term |
|---|---|
| D009221 | Myositis Ossificans |
| ID | Term |
|---|---|
| D009220 | Myositis |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.
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| Placebo | Placebo Comparator | Participants will be randomized to receive a single, subcutaneous injection of placebo. |
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| Placebo | Drug | Placebo will be administered as a single subcutaneous injection into the upper arm, upper part of the thigh, or abdominal wall |
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| 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 | 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. | 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 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 |
| 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 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 |
| Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) | The immunogenicity of DS-6016a will be assessed. | Day 1 (pre-dose), Day 29 and Day 57 post-dose |
| Proportion of Participants Who Have Treatment-emergent ADAs | The immunogenicity of DS-6016a will be assessed. | Day 1 (pre-dose), Day 29 and Day 57 post-dose |
| Proportion of Participants Who Have Anti-host Cell Protein (HCP) Antibodies | The immunogenicity of DS-6016a will be assessed. | Day 1 (pre-dose), Day 29 and Day 57 post-dose |