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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
Are there results?: None posted in the registry

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.

Japan1 site

Medical Corporation Heishinkai OPHAC Hospital
Osaka, 532-0003

Other trials in Japan

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 groups in NCT04818398
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.

1 Apr 202126 Jul 2022

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2/3
A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
Fibrodysplasia Ossificans Progressiva
RecruitingObservational study
A Study to Document and to Further Describe Long-term Safety and Effectiveness of Palovarotene in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
Fibrodysplasia Ossificans Progressiva
RecruitingPhase 2
To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
Fibrodysplasia Ossificans Progressiva (FOP)
Not yet recruitingPhase 3
A Study to Investigate the Safety, Pharmacokinetics (PK), and Efficacy of Garetosmab in Children and Adolescents With Fibrodysplasia Ossificans Progressiva (FOP)
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Active, not recruitingPhase 2
Saracatinib Trial TO Prevent FOP
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All Fibrodysplasia Ossificans Progressiva trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04818398
Acronym / sponsor ID: DS6016-A-J101
Conditions: Fibrodysplasia Ossificans Progressiva
Keywords: Fibrodysplasia Ossificans Progressiva, Bone Morphogenetic Protein, Activin Receptor-like Kinase-2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
Study start: 1 Apr 2021 (actual)
Primary completion: 24 Dec 2021 (actual)
Study completion: 26 Jul 2022 (actual)
First posted: 26 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 7

Arm	Type	Receives
DS-6016a dose level 1	Experimental	Drug: DS-6016aParticipants will be randomized to receive a single, subcutaneous injection of DS-6016a.
DS-6016a dose level 2	Experimental	Drug: DS-6016aParticipants will be randomized to receive a single, subcutaneous injection of DS-6016a.
DS-6016a dose level 3	Experimental	Drug: DS-6016aParticipants will be randomized to receive a single, subcutaneous injection of DS-6016a.
DS-6016a dose level 4	Experimental	Drug: DS-6016aParticipants will be randomized to receive a single, subcutaneous injection of DS-6016a.
DS-6016a dose level 5	Experimental	Drug: DS-6016aParticipants will be randomized to receive a single, subcutaneous injection of DS-6016a.
DS-6016a dose level 6	Experimental	Drug: DS-6016aParticipants will be randomized to receive a single, subcutaneous injection of DS-6016a.
Placebo	Placebo comparator	Drug: PlaceboParticipants will be randomized to receive a single, subcutaneous injection of placebo.

Who may qualify

Ages: 20 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DS-6016aDS-6016a will be administered as a single subcutaneous injection into the upper arm, upper part of the thigh, or abdominal wall	Drug	DS-6016a dose level 1, DS-6016a dose level 2, DS-6016a dose level 3, DS-6016a dose level 4, DS-6016a dose level 5, DS-6016a dose level 6
PlaceboPlacebo will be administered as a single subcutaneous injection into the upper arm, upper part of the thigh, or abdominal wall	Drug	Placebo

Primary outcome

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

9 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
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
Pharmacokinetic Parameter of Terminal elimination half-life (t1/2) 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 Volume of Distribution (Vz/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
Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline)
Time frame: Day 1 (pre-dose), Day 29 and Day 57 post-dose
Proportion of Participants Who Have Treatment-emergent ADAs
Time frame: Day 1 (pre-dose), Day 29 and Day 57 post-dose
Proportion of Participants Who Have Anti-host Cell Protein (HCP) Antibodies
Time frame: Day 1 (pre-dose), Day 29 and Day 57 post-dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
Derived from this study: PubMed 41562506Okita 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.
Individual participant dataSharing planned: 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/

Related trials for Fibrodysplasia Ossificans Progressiva

Active, not recruitingPhase 2/3
A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
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RecruitingObservational study
A Study to Document and to Further Describe Long-term Safety and Effectiveness of Palovarotene in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Leader study director

Daiichi Sankyo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DS-6016a in people with Fibrodysplasia Ossificans Progressiva, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reporting Treatment-emergent Adverse Events (time frame: Day 1 through end of study, up to 8 weeks post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04818398, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.