Fibrodysplasia Ossificans ProgressivaPhase 1NCT04818398
Study of Single-Ascending Doses of DS-6016a in Healthy Japanese Subjects
A Phase 1 study testing DS-6016a in people with Fibrodysplasia Ossificans Progressiva, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.
Trial summary
This study will assess the safety, tolerability, and pharmacokinetics of DS-6016a after subcutaneous injection in healthy Japanese participants. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fibrodysplasia Ossificans Progressiva
- What is being tested?
- DS-6016a
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteJapan
- Study dates
- 1 Apr 2021to 26 Jul 2022
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Have a history of hypersensitivity to any drugs or substances, or being idiosyncratic (eg, having penicillin allergy)
- Have alcohol or drug dependence, etc.
Trial locations and contacts
1 site in 1 country.
About this study
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
This study will assess the safety, tolerability, and pharmacokinetics of DS-6016a after subcutaneous injection in healthy Japanese participants.
- Conditions
- Fibrodysplasia Ossificans Progressiva
- Being tested
- DS-6016a, Placebo
- Keywords
- Fibrodysplasia Ossificans Progressiva, Bone Morphogenetic Protein, Activin Receptor-like Kinase-2
- Medical subject headings
- Myositis Ossificans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| DS-6016a dose level 1 | Experimental | Participants will be randomized to receive a single, subcutaneous injection of DS-6016a. Receives: Drug: DS-6016a |
| DS-6016a dose level 2 | Experimental | Participants will be randomized to receive a single, subcutaneous injection of DS-6016a. Receives: Drug: DS-6016a |
| DS-6016a dose level 3 | Experimental | Participants will be randomized to receive a single, subcutaneous injection of DS-6016a. Receives: Drug: DS-6016a |
| DS-6016a dose level 4 | Experimental | Participants will be randomized to receive a single, subcutaneous injection of DS-6016a. Receives: Drug: DS-6016a |
| DS-6016a dose level 5 | Experimental | Participants will be randomized to receive a single, subcutaneous injection of DS-6016a. Receives: Drug: DS-6016a |
| DS-6016a dose level 6 | Experimental | Participants will be randomized to receive a single, subcutaneous injection of DS-6016a. Receives: Drug: DS-6016a |
| Placebo | Placebo comparator | Participants will be randomized to receive a single, subcutaneous injection of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Treatment-emergent Adverse Events
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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 Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline)
The immunogenicity of DS-6016a will be assessed.
Measured: Day 1 (pre-dose), Day 29 and Day 57 post-dose
Proportion of Participants Who Have Treatment-emergent ADAs
The immunogenicity of DS-6016a will be assessed.
Measured: Day 1 (pre-dose), Day 29 and Day 57 post-dose
Proportion of Participants Who Have Anti-host Cell Protein (HCP) Antibodies
The immunogenicity of DS-6016a will be assessed.
Measured: Day 1 (pre-dose), Day 29 and Day 57 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Apr 2021
- Primary completion24 Dec 2021
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fibrodysplasia Ossificans ProgressivaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818398
- Sponsor's protocol ID
- DS6016-A-J101
- Other IDs
- jRCT2051200155
- Status last verified
- Aug 2022
- First submitted
- 24 Mar 2021
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/
Publications
Okita K, Furuie H, Kurata A, Owada Y, Yoshiba S, Furihata K, Oka T, Kashihara Y, Ishizuka H, Yoshihara K. First-In-Human Study to Assess the Pharmacokinetics and Safety of DS-6016a After Single Subcutaneous Injection in Healthy Japanese Adults. Clin Pharmacol Drug Dev. 2026 Jan;15(1):e70023. doi: 10.1002/cpdd.70023.
PubMed 41562506