NCT04818398
Completed
Phase 1
Single-Ascending Dose Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-6016a After Subcutaneous Injection in Healthy Japanese Subjects
Overview
- Phase
- Phase 1
- Intervention
- DS-6016a
- Conditions
- Fibrodysplasia Ossificans Progressiva
- Sponsor
- Daiichi Sankyo Co., Ltd.
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Number of Participants Reporting Treatment-emergent Adverse Events
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This study will assess the safety, tolerability, and pharmacokinetics of DS-6016a after subcutaneous injection in healthy Japanese participants.
Investigators
Eligibility Criteria
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.
Arms & Interventions
DS-6016a dose level 2
Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.
Intervention: DS-6016a
DS-6016a dose level 1
Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.
Intervention: DS-6016a
DS-6016a dose level 3
Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.
Intervention: DS-6016a
DS-6016a dose level 4
Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.
Intervention: DS-6016a
DS-6016a dose level 5
Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.
Intervention: DS-6016a
DS-6016a dose level 6
Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.
Intervention: DS-6016a
Placebo
Participants will be randomized to receive a single, subcutaneous injection of placebo.
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants Reporting Treatment-emergent Adverse Events
Time Frame: Day 1 through end of study, up to 8 weeks post-dose
Secondary Outcomes
- 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)
- Proportion of Participants Who Have Anti-host Cell Protein (HCP) Antibodies(Day 1 (pre-dose), Day 29 and Day 57 post-dose)
- 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)
- 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)
- 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)
- Proportion of Participants Who Have Treatment-emergent ADAs(Day 1 (pre-dose), Day 29 and Day 57 post-dose)
Study Sites (1)
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