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

Phase 1

Completed

• Conditions: Fibrodysplasia Ossificans Progressiva
• Interventions: Drug: Placebo; Drug: DS-6016a

• Registration Number: NCT04818398
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-24
• Study First Posted: 2021-03-26
• Study Start: 2021-04-01
• Primary Completion: 2021-12-24
• Study Completion: 2022-07-26
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will be randomized to receive a single, subcutaneous injection of placebo.
DS-6016a dose level 2	DS-6016a	Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.
DS-6016a dose level 1	DS-6016a	Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.
DS-6016a dose level 5	DS-6016a	Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.
DS-6016a dose level 3	DS-6016a	Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.
DS-6016a dose level 4	DS-6016a	Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.
DS-6016a dose level 6	DS-6016a	Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting Treatment-emergent Adverse Events	Day 1 through end of study, up to 8 weeks post-dose

Secondary Outcome Measures

Name	Time	Method
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	The immunogenicity of DS-6016a will be assessed.
Proportion of Participants Who Have Anti-host Cell Protein (HCP) Antibodies	Day 1 (pre-dose), Day 29 and Day 57 post-dose	The immunogenicity of DS-6016a will be assessed.
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	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.
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	The immunogenicity of DS-6016a will be assessed.

Trial Locations

Locations (1)

Medical Corporation Heishinkai OPHAC Hospital; 🇯🇵 Osaka, Japan