Coronary Artery Disease (CAD)Phase 2NCT07318155
A Study of SRSD107 in Participants With Chronic Coronary and/or Peripheral Arterial Disease
A Phase 2 study testing SRSD107 and 0.9 % sodium chloride in people with Coronary Artery Disease (CAD) and Peripheral Arterial Disease, run by Sirius Therapeutics Co., Ltd. at 1 site in China.
Trial summary
The study is a Phase 2a, randomized, double-blind, placebo-controlled, sequential cohort study to evaluate the pharmacodynamics (PD), safety and pharmacokinetics (PK) of multiple doses of SRSD107 in participants with coronary arterial disease (CAD) and/or peripheral arterial disease (PAD) with aspirin as background… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease (CAD), Peripheral Arterial Disease
- What is being tested?
- SRSD107 and 0.9 % sodium chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2025to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
- Males or females aged 18 to 75 years, inclusive.
- Body mass index (BMI) between 18.0 and 35.0 kg/m2, inclusive.
- History of chronic coronary and/or peripheral arterial disease
Who cannot join
- Known bleeding disorder
- Severe heart failure with known left ventricular ejection fraction <35%, or New York Heart Association (NYHA) class III or IV symptoms.
- Genetic cardiomyopathies or other non-ischemic cardiomyopathies that are not related to atherosclerotic cardiovascular disease.
- History of ethanol abuse or addictive drug use (cannabis products allowed) within 6 months of screening.
- Receipt of an investigational drug (IP) within 30 days or 5 half-lives of that drug, whichever is longer, prior to dose administration in this study.
- Previous use of SRSD107.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital
Beijing
MD, +86 21 61207756, medical@siriusrna.com
Medical Director
About this study
Official title: A Phase 2a Randomized, Double-Blind, Placebo-Controlled, Sequential Cohort Study to Evaluate the Pharmacodynamics, Safety and Pharmacokinetics of Subcutaneously Administered SRSD107 in Participants With Chronic Coronary and/or Peripheral Arterial Disease
The study is a Phase 2a, randomized, double-blind, placebo-controlled, sequential cohort study to evaluate the pharmacodynamics (PD), safety and pharmacokinetics (PK) of multiple doses of SRSD107 in participants with coronary arterial disease (CAD) and/or peripheral arterial disease (PAD) with aspirin as background concomitant therapy.
- Being tested
- SRSD107, 0.9 % sodium chloride
- Medical subject headings
- Coronary Artery Disease, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRSD107Drug
Administered S.C.
0.9 % sodium chlorideDrug
Administered S.C.
| Study group | Role | What they receive |
|---|---|---|
| SRSD107 dose level 1 | Experimental | Administered S.C. Receives: Drug: SRSD107 |
| SRSD107 dose level 2 | Experimental | Administered S.C. Receives: Drug: SRSD107 |
| SRSD107 dose level 3 | Experimental | Administered S.C. Receives: Drug: SRSD107 |
| SRSD107 dose level 4 | Experimental | Administered S.C. Receives: Drug: SRSD107 |
| Placebo | Placebo comparator | Administered S.C. Receives: Drug: 0.9 % sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in time-averaged FXI antigen
Measured: 72 weeks
Secondary outcomes (5)
Percent change from baseline in FXI antigen, FXI activity and aPTT
Measured: 72 weeks
Maximal concentration of SRSD107
Measured: 72 weeks
Area under the concentration-time curve from time 0 to infinity of SRSD107
Measured: 72 weeks
Time to the maximal concentration of SRSD107
Measured: 72 weeks
Incidence of adverse events
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start11 Mar 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sirius Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318155
- Sponsor's protocol ID
- SRSD107-202
- Status last verified
- Apr 2026
- First submitted
- 7 Dec 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Randomized, Double-Blind, Placebo-Controlled, Sequential Cohort Study to Evaluate the Pharmacodynamics, Safety and Pharmacokinetics of Subcutaneously Administered SRSD107 in Participants With Chronic Coronary and/or Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT07318155
- Acronym / sponsor ID
- SRSD107-202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Sirius Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Jan 2026 (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 study is a Phase 2a, randomized, double-blind, placebo-controlled, sequential cohort study to evaluate the pharmacodynamics (PD), safety and pharmacokinetics (PK) of multiple doses of SRSD107 in participants with coronary arterial disease (CAD) and/or peripheral arterial disease (PAD) with aspirin as background concomitant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SRSD107 dose level 1 | Experimental | Drug: SRSD107Administered S.C. |
| SRSD107 dose level 2 | Experimental | Drug: SRSD107Administered S.C. |
| SRSD107 dose level 3 | Experimental | Drug: SRSD107Administered S.C. |
| SRSD107 dose level 4 | Experimental | Drug: SRSD107Administered S.C. |
| Placebo | Placebo comparator | Drug: 0.9 % sodium chlorideAdministered S.C. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
- Males or females aged 18 to 75 years, inclusive.
- Body mass index (BMI) between 18.0 and 35.0 kg/m2, inclusive.
- History of chronic coronary and/or peripheral arterial disease
Key exclusion criteria (6 listed)
- Known bleeding disorder
- Severe heart failure with known left ventricular ejection fraction <35%, or New York Heart Association (NYHA) class III or IV symptoms.
- Genetic cardiomyopathies or other non-ischemic cardiomyopathies that are not related to atherosclerotic cardiovascular disease.
- History of ethanol abuse or addictive drug use (cannabis products allowed) within 6 months of screening.
- Receipt of an investigational drug (IP) within 30 days or 5 half-lives of that drug, whichever is longer, prior to dose administration in this study.
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 |
|---|---|---|
| SRSD107Administered S.C. | Drug | SRSD107 dose level 1, SRSD107 dose level 2, SRSD107 dose level 3, SRSD107 dose level 4 |
| 0.9 % sodium chlorideAdministered S.C. | Drug | Placebo |
Primary outcome
Percent change from baseline in time-averaged FXI antigen
Time frame: 72 weeks
5 secondary outcomes
Percent change from baseline in FXI antigen, FXI activity and aPTT
Time frame: 72 weeks
Maximal concentration of SRSD107
Time frame: 72 weeks
Area under the concentration-time curve from time 0 to infinity of SRSD107
Time frame: 72 weeks
Time to the maximal concentration of SRSD107
Time frame: 72 weeks
Incidence of adverse events
Time frame: 72 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SRSD107 and 0.9 % sodium chloride in people with Coronary Artery Disease (CAD) and Peripheral Arterial Disease, run by Sirius Therapeutics 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline in time-averaged FXI antigen (time frame: 72 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2026.