Clinical trial NCT04818398: Study of Single-Ascending Doses of DS-6016a in Healthy Japanese Subjects
Official title: Single-Ascending Dose Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-6016a After Subcutaneous Injection in Healthy Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fibrodysplasia Ossificans Progressiva
Keywords: Fibrodysplasia Ossificans Progressiva
Bone Morphogenetic Protein
Activin Receptor-like Kinase-2
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2021-03-26
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Number of Participants Reporting Treatment-emergent Adverse Events
timeFrame: Day 1 through end of study, up to 8 weeks post-dose
Secondary outcomes:
measure: Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a
timeFrame: 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
measure: Pharmacokinetic Parameter of Time to Reach Maximum Concentration (Tmax) of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a
timeFrame: 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
measure: Pharmacokinetic Parameter of Area Under the Concentration-time Curve of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a
timeFrame: 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
measure: Pharmacokinetic Parameter of Total Clearance (CL/F) of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a
timeFrame: 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
measure: Pharmacokinetic Parameter of Terminal elimination half-life (t1/2) of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a
timeFrame: 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
measure: Pharmacokinetic Parameter of Volume of Distribution (Vz/F) of Plasma DS-6016a Following Subcutaneous Administration of DS-6016a
timeFrame: 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
measure: Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline)
timeFrame: Day 1 (pre-dose), Day 29 and Day 57 post-dose
measure: Proportion of Participants Who Have Treatment-emergent ADAs
timeFrame: Day 1 (pre-dose), Day 29 and Day 57 post-dose
measure: Proportion of Participants Who Have Anti-host Cell Protein (HCP) Antibodies
timeFrame: Day 1 (pre-dose), Day 29 and Day 57 post-dose
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Medical Corporation Heishinkai OPHAC Hospital
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: