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

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

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

Conditions
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Fibrodysplasia Ossificans Progressiva

Intervention / Treatment
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* Drug: DS-6016a
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DS-6016a dose level 1<br>Participants will be randomized to receive a single, subcutaneous injection of DS-6016a. | Drug: DS-6016a<br>* DS-6016a will be administered as a single subcutaneous injection into the upper arm, upper part of the thigh, or abdominal wall<br>|
| Experimental: DS-6016a dose level 2<br>Participants will be randomized to receive a single, subcutaneous injection of DS-6016a. | Drug: DS-6016a<br>* DS-6016a will be administered as a single subcutaneous injection into the upper arm, upper part of the thigh, or abdominal wall<br>|
| Experimental: DS-6016a dose level 3<br>Participants will be randomized to receive a single, subcutaneous injection of DS-6016a. | Drug: DS-6016a<br>* DS-6016a will be administered as a single subcutaneous injection into the upper arm, upper part of the thigh, or abdominal wall<br>|
| Experimental: DS-6016a dose level 4<br>Participants will be randomized to receive a single, subcutaneous injection of DS-6016a. | Drug: DS-6016a<br>* DS-6016a will be administered as a single subcutaneous injection into the upper arm, upper part of the thigh, or abdominal wall<br>|
| Experimental: DS-6016a dose level 5<br>Participants will be randomized to receive a single, subcutaneous injection of DS-6016a. | Drug: DS-6016a<br>* DS-6016a will be administered as a single subcutaneous injection into the upper arm, upper part of the thigh, or abdominal wall<br>|
| Experimental: DS-6016a dose level 6<br>Participants will be randomized to receive a single, subcutaneous injection of DS-6016a. | Drug: DS-6016a<br>* DS-6016a will be administered as a single subcutaneous injection into the upper arm, upper part of the thigh, or abdominal wall<br>|
| Placebo Comparator: Placebo<br>Participants will be randomized to receive a single, subcutaneous injection of placebo. | Drug: Placebo<br>* Placebo will be administered as a single subcutaneous injection into the upper arm, upper part of the thigh, or abdominal wall<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibrodysplasia Ossificans Progressiva, Bone Morphogenetic Protein, Activin Receptor-like Kinase-2