NCT04818398

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2022

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

9 months

First QC Date

March 24, 2021

Last Update Submit

August 2, 2022

Conditions

Fibrodysplasia Ossificans Progressiva

Keywords

Fibrodysplasia Ossificans ProgressivaBone Morphogenetic ProteinActivin Receptor-like Kinase-2

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Reporting Treatment-emergent Adverse Events

    Day 1 through end of study, up to 8 weeks post-dose

Secondary Outcomes (9)

  • 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

  • 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

  • +4 more secondary outcomes

Study Arms (7)

DS-6016a dose level 1

EXPERIMENTAL

Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.

Drug: DS-6016a

DS-6016a dose level 2

EXPERIMENTAL

Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.

Drug: DS-6016a

DS-6016a dose level 3

EXPERIMENTAL

Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.

Drug: DS-6016a

DS-6016a dose level 4

EXPERIMENTAL

Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.

Drug: DS-6016a

DS-6016a dose level 5

EXPERIMENTAL

Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.

Drug: DS-6016a

DS-6016a dose level 6

EXPERIMENTAL

Participants will be randomized to receive a single, subcutaneous injection of DS-6016a.

Drug: DS-6016a

Placebo

PLACEBO COMPARATOR

Participants will be randomized to receive a single, subcutaneous injection of placebo.

Drug: Placebo

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

DS-6016a dose level 1DS-6016a dose level 2DS-6016a dose level 3DS-6016a dose level 4DS-6016a dose level 5DS-6016a dose level 6
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age20 Years - 45 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Have a history of hypersensitivity to any drugs or substances, or being idiosyncratic (eg, having penicillin allergy)
  • Have alcohol or drug dependence, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Corporation Heishinkai OPHAC Hospital

Osaka, 532-0003, Japan

Location

MeSH Terms

Conditions

Myositis Ossificans

Condition Hierarchy (Ancestors)

MyositisMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • Global Clinical Leader

    Daiichi Sankyo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2021

First Posted

March 26, 2021

Study Start

April 1, 2021

Primary Completion

December 24, 2021

Study Completion

July 26, 2022

Last Updated

August 3, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
More information

Locations

JP(1)