Prevention of Arterial and Venous ThrombosisPhase 1NCT05369767
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single-dose Injection of SHR-2004 in Healthy Subjects
A Phase 1 study testing SAD, SHR-2004 in people with Prevention of Arterial and Venous Thrombosis, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site in China.
Trial summary
The primary objective of this study is to assess the safety and tolerability of SHR-2004 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmacodynamics of SHR-2004 injection in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention of Arterial and Venous Thrombosis
- What is being tested?
- SAD, SHR-2004
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2022to 30 Jan 2023
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- males or females, aged 18-55;
- body mass index (BMI) between 19 kg/m2 to 28 kg/m2, and a total body weight: male ≥50.0 kg and <90.0 kg; female ≥45.0 kg and <90.0 kg.
Who cannot join
- previous medical history of coagulation or bleeding disorders;
- known risks of bleeding or thrombosis, such as recurrent gingival bleeding, spontaneous bleeding, haemorrhoids, gastrointestinal ulcers, or other high-risk bleeding diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Drum Tower Hospital of Nanjing University Medical school
Nanjing, Jiangsu, 210008
About this study
Official title: A Phase 1, Randomized, Double Blind, Dose-escalation, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 in Healthy Subjects
The primary objective of this study is to assess the safety and tolerability of SHR-2004 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmacodynamics of SHR-2004 injection in healthy subjects.
- Being tested
- SAD, SHR-2004, SAD, SHR-2004 placebo
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAD, SHR-2004Drug
Ascending dose
SAD, SHR-2004 placeboDrug
Ascending dose
| Study group | Role | What they receive |
|---|---|---|
| SAD, SHR-2004 | Experimental | Up to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 injection Receives: Drug: SAD, SHR-2004 |
| SAD, SHR-2004 placebo | Placebo comparator | Up to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 placebo injection Receives: Drug: SAD, SHR-2004 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Measured: up to day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start24 May 2022
- Primary completion30 Jan 2023 (estimated)
- Study completion30 Jan 2023 (estimated)
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 Prevention of Arterial and Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Beijing Suncadia Pharmaceuticals Co., LtdThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SHR-2004 injection compared with placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369767
- Sponsor's protocol ID
- SHR-2004-101
- Status last verified
- Nov 2022
- First submitted
- 6 May 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ma T, Weng Z, Cao B, Dong Y, Deng C, Huang L, Yang Y, Wang Y, Shen C, Wang L, Shen K, Li J. The first-in-human study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the factor XI monoclonal antibody SHR-2004 in healthy subjects. Expert Opin Investig Drugs. 2024 Oct;33(10):1075-1082. doi: 10.1080/13543784.2024.2391837. Epub 2024 Aug 22.
PubMed 39166425
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double Blind, Dose-escalation, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05369767
- Acronym / sponsor ID
- SHR-2004-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 24 May 2022 (actual)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 11 May 2022 (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.
The primary objective of this study is to assess the safety and tolerability of SHR-2004 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmacodynamics of SHR-2004 injection in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- SHR-2004 injection compared with placebo
| Arm | Type | Receives |
|---|---|---|
| SAD, SHR-2004 | Experimental | Drug: SAD, SHR-2004Up to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 injection |
| SAD, SHR-2004 placebo | Placebo comparator | Drug: SAD, SHR-2004 placeboUp to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 placebo injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- males or females, aged 18-55;
- body mass index (BMI) between 19 kg/m2 to 28 kg/m2, and a total body weight: male ≥50.0 kg and <90.0 kg; female ≥45.0 kg and <90.0 kg.
Key exclusion criteria (2 listed)
- previous medical history of coagulation or bleeding disorders;
- known risks of bleeding or thrombosis, such as recurrent gingival bleeding, spontaneous bleeding, haemorrhoids, gastrointestinal ulcers, or other high-risk bleeding diseases.
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 |
|---|---|---|
| SAD, SHR-2004Ascending dose | Drug | SAD, SHR-2004 |
| SAD, SHR-2004 placeboAscending dose | Drug | SAD, SHR-2004 placebo |
Primary outcome
To assess the number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Time frame: up to day 113
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Derived from this study: PubMed 39166425Ma T, Weng Z, Cao B, Dong Y, Deng C, Huang L, Yang Y, Wang Y, Shen C, Wang L, Shen K, Li J. The first-in-human study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the factor XI monoclonal antibody SHR-2004 in healthy subjects. Expert Opin Investig Drugs. 2024 Oct;33(10):1075-1082. doi: 10.1080/13543784.2024.2391837. Epub 2024 Aug 22.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 SAD, SHR-2004 in people with Prevention of Arterial and Venous Thrombosis, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 30 Nov 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 China. 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?
Results are not available in the source record.
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?
To assess the number of subjects with adverse events (AEs) and serious adverse events (SAEs) (time frame: up to day 113). 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 NCT05369767, 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 30 Nov 2022.