NCT04818398 - Study of Single-Ascending Doses of DS-6016a in Healthy Japanese Subjects | Crick

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

48

Conditions

Fibrodysplasia Ossificans Progressiva

Interventions

DS-6016aDRUG

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

PlaceboDRUG

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

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Medical Corporation Heishinkai OPHAC Hospital

Osaka, Japan

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

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

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

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.

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

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