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ThrombusPhase 1NCT07655427

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SRSD107 in Healthy Chinese Subjects

A Phase 1 study testing SRSD107 in people with Thrombus, run by Sirius Therapeutics Co., Ltd. at 1 site in China.

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 was a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneously administered SRSD107 in Chinese healthy subjects. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Thrombus
What is being tested?
SRSD107
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 siteChina
Study dates
29 Mar 2024to 2 Mar 2025
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Males or females, of any race, between 18 and 65 years of age, inclusive.
  • Body mass index between 18.0 and 32.0 kg/square meter, inclusive.
  • In good health, determined by no clinically significant findings from medical history, physical examination, clinical laboratory evaluations, 12 lead ECG, and vital signs measurements, at screening and check in, as assessed by the investigator (or designee).
  • Activated partial thromboplastin time and prothrombin time within the normal reference range.
  • Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as pre-defined in the protocol.
  • Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Who cannot join

  • Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
  • History or evidence of any abnormal bleeding or coagulation disorder; or evidence of coagulopathy, prolonged or unexplained, clinically significant bleeding, or frequent unexplained bruising or thrombus formation; or a history of spontaneous bleeding.
  • Evidence of an active or suspected cancer, or a history of malignancy, within 5 years prior to screening. Nonmelanoma skin cancer, curatively treated localized prostate cancer, or other carcinoma in situ are not exclusionary, providing that they did not require systemic therapy and are considered cured.
  • Acute of febrile illness within 7 days prior to dose administration or evidence of active infection.
  • Any major surgery within 3 months prior to screening or plan to have any surgery during the study.
  • History of clinically significant hypersensitivity, intolerance, or allergy to any drug compound, oligonucleotide, GalNAc, food, or other substance, as determined by the investigator (or designee).
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  • Systolic blood pressure >140 mmHg or <90 mmHg, or diastolic blood pressure >90 mmHg or <50 mmHg confirmed by repeat measurement.
  • QT interval corrected for heart rate using Fridericia's method (QTcF) >450 ms confirmed by repeat measurement.
  • Platelet count or hemoglobin level below the lower limit of normal.
  • Alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, alkaline phosphatase, or total bilirubin >1.5 × the upper limit of normal.
  • Estimated glomerular filtration rate <80 mL/min/1.73 square meter, as calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration equation.
  • Positive hepatitis B and C, positive human immunodeficiency virus test or positive syphilis test. Subjects whose results are compatible with prior immunization may be included.
  • Positive pregnancy test at screening or check in.
  • Women who are menstruating at dosing, and women whose past volume of menstrual fluid was >80 mL or menstrual periods were >7 days.
  • Use or intend to use any of the following, as determined by the investigator (or designee): 1) prescription medications/products or herbal products within 14 days or 5 terminal elimination half lives, whichever is longer, prior to dose administration in this study; 2) over the counter medications/products within 7 days prior to dose administration in this study. Recommended doses of vitamin and mineral supplements, over the counter analgesics (eg, paracetamol or ibuprofen for the treatment of acute conditions [eg, headache]), prescription oral, implantable, transdermal, injectable, or intrauterine contraceptives, and other products that have been approved by the investigator will not be exclusionary. Hormone replacement therapy will not be exclusionary, providing that the regimen has been stable for at least 2 months prior to screening and will not be changed during the study.
  • Immunization with any live vaccine within 6 weeks prior to screening, or expected to require immunization with any live vaccine during the study.
  • Receipt of an investigational drug in the past 90 days or 5 half lives of that drug, whichever is longer, prior to dosing in this study.
  • Receipt of any siRNA treatment within 12 months or any antisense oligonucleotide treatment within 6 months prior to dosing in this study.
  • Have previously completed or withdrawn from this study or any other study investigating SRSD107 and have previously received SRSD107.
  • Drug abuse or addiction within 1 year prior to screening, as determined by the investigator (or designee).
  • Positive alcohol or cotinine test result or positive urine drug screen (confirmed by repeat) at screening or check in.
  • Regular alcohol consumption of >21 units per week for males and >14 units for females within 12 months prior to screening. One unit of alcohol equals 375 mL of beer or lager (3.5%), 100 mL of wine (13.5%), or 30 mL of spirits (40%).
  • Use of tobacco or nicotine containing products within 1 months prior to screening.
  • Receipt of blood products within 3 months prior to check in.
  • Loss of >500 mL whole blood or donation of >200 mL blood products within 1 month prior to screening.
  • History of intolerance to subcutaneous injections, or scarring (eg, from surgical procedures or burns) in areas when subcutaneous dose administration may occur.
  • Poor peripheral venous access.
  • Subjects who, in the opinion of the investigator (or designee), should not participate in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Tiantan Hospital Affiliated to Capital Medical University

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SRSD107 in Healthy Subjects

This was a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneously administered SRSD107 in Chinese healthy subjects. SRSD107 is a synthetic, chemically modified double-stranded siRNA designed to silence hepatic FXI mRNA, thereby modulating coagulation.

Conditions
Thrombus
Being tested
SRSD107, Placebo
Medical subject headings
Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SRSD107Drug

    SRSD107 is a synthetic, chemically modified double-stranded siRNA designed to silence hepatic FXI mRNA, thereby modulating coagulation.

  • PlaceboDrug

    Sodium chloride for subcutaneous injection.

Study groups in NCT07655427
Study groupRoleWhat they receive
SRSD107ExperimentalNot described
Receives: Drug: SRSD107
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of adverse events (AEs)

    Measured: up to 168 days post last dose

  2. Proportion of Serious Adverse Events (SAEs)

    Measured: up to 168 days post last dose

Secondary outcomes (9)

  1. Peak Concentration

    Measured: Day 1 to Day 3

  2. Time to maximum concentration

    Measured: Day1 to Day3

  3. Elimination half-life

    Measured: Day1 to Day3

  4. Area Under Curve

    Measured: Day1 to Day3

  5. Apparent total clearance

    Measured: Day1 to Day3

  6. Prothrombin Time

    Measured: up to 168 days post last dose

  7. Activated Partial Thromboplastin Time

    Measured: up to 168 days post last dose

  8. FXI avtivity in peripheral blood (quantitative laboratory measurement)

    Coagulation Factor XI (FXI) is a plasma serine protease zymogen predominantly synthesized in the liver. As a key protein in the intrinsic coagulation pathway, it circulates in the bloodstream as a homodimer.

    Measured: up to 168 days post last dose

  9. FXI antigen concentration in peripheral blood (quantitative laboratory measurement)

    Coagulation Factor XI (FXI) is a plasma serine protease zymogen predominantly synthesized in the liver. As a key protein in the intrinsic coagulation pathway, it circulates in the bloodstream as a homodimer.

    Measured: up to 168 days post last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2026
  2. Study start29 Mar 2024
  3. Primary completion2 Mar 2025
  4. Study completion2 Mar 2025

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07655427
Sponsor's protocol ID
SRSD107-102
Other IDs
ChiCTR2600120343
Status last verified
Jun 2026
First submitted
8 Jun 2026
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SRSD107 in people with Thrombus, 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 6 inclusion and 28 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 17 Jun 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 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?

Proportion of adverse events (AEs) (time frame: up to 168 days post last dose). The study lists 2 primary outcomes in all. 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 NCT07655427.

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 17 Jun 2026.

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