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

• Sponsor: Daiichi Sankyo Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04818398
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 7
• Actual Duration (Months): 15.8
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Fibrodysplasia Ossificans Progressiva	Drug: DS-6016a; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 1, 2021
• Actual Primary Completion Date: Dec 24, 2021
• Actual Study Completion Date: Jul 26, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Participants Reporting Treatment-emergent Adverse Events [Day 1 through end of study, up to 8 weeks post-dose]

Secondary Outcome Measures

1. 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]

2. 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]

3. 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.

4. 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]

5. 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]

6. 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]

7. 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.

8. 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.

9. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Corporation Heishinkai OPHAC Hospital	Osaka		Japan	532-0003

Sponsors and Collaborators

• Daiichi Sankyo Co., Ltd.

Investigators

• Study Director: Global Clinical Leader, Daiichi Sankyo, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daiichi Sankyo Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04818398
• Other Study ID Numbers: DS6016-A-J101; jRCT2051200155
• First Posted: Mar 26, 2021
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Daiichi Sankyo Co., Ltd.: Fibrodysplasia Ossificans Progressiva; Bone Morphogenetic Protein; Activin Receptor-like Kinase-2
• Additional relevant MeSH terms: Myositis Ossificans

Study Results

No Results Posted as of Aug 3, 2022