ThrombosisPhase 1NCT06116617
A Phase 1 Study to Evaluate the Safety, Tolerability, PK/PD of SRSD107 in Healthy Participants
A Phase 1 study testing SRSD107 in people with Thrombosis, run by Sirius Therapeutics Co., Ltd. at 1 site in Australia.
Trial summary
The primary aim of this study is to evaluate safety and tolerability data when SRSD107 is administered as single SC injections to healthy participants. This information, along with PK/PD data, will help establish the appropriate doses and dosing regimen for future studies in patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thrombosis
- 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
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 23 Jan 2024to 30 Apr 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
- Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- In good health, based on no clinically significant findings from medical history, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations.
- Activated partial thromboplastin time and PT within the normal range.
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
- Able to understand 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).
Show all 17Show fewer
- Confirmed systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg.
- QT interval corrected for heart rate using Fridericia's method (QTcF) >450 ms in males or >470 ms in females confirmed by repeat measurement.
- White blood cell count <3.5 × 109/L, platelets <100 × 109/L, or hemoglobin 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 (ULN).
- Estimated glomerular filtration rate <80 mL/min/1.73m2, as calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration equation.
- Positive hepatitis panel and/or positive human immunodeficiency virus test.
- Positive pregnancy test at screening or check in.
- Receipt of blood products within 2 months prior to check in.
- Loss of >500 mL whole blood or donation of blood products within 1 month prior to screening.
- History of intolerance to SC injections, or scarring (eg, from surgical procedures or burns) in areas when SC dose administration may occur.
- Participants who, in the opinion of the investigator (or designee), should not participate in this study.
Trial locations and contacts
1 site in 1 country.
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 Participants
The primary aim of this study is to evaluate safety and tolerability data when SRSD107 is administered as single SC injections to healthy participants. This information, along with PK/PD data, will help establish the appropriate doses and dosing regimen for future studies in patients.
Read the detailed description
SRSD107 is a synthetic, chemically modified double-stranded, small interfering ribonucleic acid (siRNA). The antisense strand is specifically designed to recognize and cleave human factor XI (FXI) messenger ribonucleic acid (mRNA) which reduces FXI protein. FXI protein reduction may prevent thromboembolic events without increasing the risk of bleeding.
This study will be a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study conducted in two parts. A total of 40 participants will be studied in 5 groups (Groups A1 to A5), each group consisting of 8 participants. In each group, 6 participants will receive SRSD107 and 2 will receive a placebo.
- Conditions
- Thrombosis
- 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, small interfering ribonucleic acid (siRNA).
PlaceboDrug
Sodium chloride
| Study group | Role | What they receive |
|---|---|---|
| SRSD107 | Experimental | SRSD107 for subcutaneous (s.c.) injection Group A1, 15mg, single dose Group A2, 45mg, single dose Group A3, 120mg, single dose Group A4, 240mg, single dose Group A5, 450mg, single dose Receives: Drug: SRSD107 |
| Placebo | Placebo comparator | Sodium chloride for subcutaneous (s.c.) injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of adverse events (AEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Measured: up to 168 days post last dose
Proportion of Serious Adverse Events (SAEs)
A serious AE (SAE) is defined as any untoward medical occurrence that at any dose either:
- results in death
- is life threatening
- requires inpatient hospitalization or prolongation of existing hospitalization
- results in persistent or significant disability/incapacity (disability is defined as a substantial disruption of a person's ability to conduct normal life functions)
- results in a congenital anomaly/birth defect
- results in an important medical event (see below).
Measured: up to 168 days post last dose
Secondary outcomes (7)
Cmax
Maximum observed plasma concentration
Measured: Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31
tmax
Time to maximum plasma concentration
Measured: Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31
t1/2
Plasma half-life
Measured: Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31
AUC
Area under the plasma concentration-time curve from 0 to infinity
Measured: Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31
CL/F
Apparent total clearance
Measured: Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31
Effect of SRSD107 on circulating FXI Levels
Determination of % Lowering of FXI to Baseline FXI Level
Measured: up to 168 days post last dose
Effect of SRSD107 on coagulation
Determination of % APTT to baseline APTT
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.
- First posted3 Nov 2023
- Study start23 Jan 2024
- Primary completion9 Dec 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sirius Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qiuyue Qu, Study director, Sirius Therapeutics Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116617
- Sponsor's protocol ID
- SRSD107-101
- Status last verified
- May 2025
- First submitted
- 30 Oct 2023
- Last updated
- 18 May 2025
- 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 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Participants
- ClinicalTrials.gov ID
- NCT06116617
- Acronym / sponsor ID
- SRSD107-101
- Conditions
- Thrombosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sirius Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 3 Nov 2023 (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 aim of this study is to evaluate safety and tolerability data when SRSD107 is administered as single SC injections to healthy participants. This information, along with PK/PD data, will help establish the appropriate doses and dosing regimen for future studies in patients.
Detailed description
SRSD107 is a synthetic, chemically modified double-stranded, small interfering ribonucleic acid (siRNA). The antisense strand is specifically designed to recognize and cleave human factor XI (FXI) messenger ribonucleic acid (mRNA) which reduces FXI protein. FXI protein reduction may prevent thromboembolic events without increasing the risk of bleeding.
This study will be a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study conducted in two parts. A total of 40 participants will be studied in 5 groups (Groups A1 to A5), each group consisting of 8 participants. In each group, 6 participants will receive SRSD107 and 2 will receive a placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SRSD107 | Experimental | Drug: SRSD107SRSD107 for subcutaneous (s.c.) injection Group A1, 15mg, single dose Group A2, 45mg, single dose Group A3, 120mg, single dose Group A4, 240mg, single dose Group A5, 450mg, single dose |
| Placebo | Placebo comparator | Drug: PlaceboSodium chloride for subcutaneous (s.c.) injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- In good health, based on no clinically significant findings from medical history, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations.
- Activated partial thromboplastin time and PT within the normal range.
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
- Able to understand and willing to sign an ICF and to abide by the study restrictions.
Key exclusion criteria (17 listed)
- 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.
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 |
|---|---|---|
| SRSD107SRSD107 is a synthetic, chemically modified double-stranded, small interfering ribonucleic acid (siRNA). | Drug | SRSD107 |
| PlaceboSodium chloride | Drug | Placebo |
Primary outcome
Proportion of adverse events (AEs)
Time frame: up to 168 days post last dose
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Proportion of Serious Adverse Events (SAEs)
Time frame: up to 168 days post last dose
A serious AE (SAE) is defined as any untoward medical occurrence that at any dose either: * results in death * is life threatening * requires inpatient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity (disability is defined as a substantial disruption of a person's ability to conduct normal life functions) * results in a congenital anomaly/birth defect * results in an important medical event (see below).
7 secondary outcomes
Cmax
Time frame: Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31
tmax
Time frame: Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31
t1/2
Time frame: Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31
AUC
Time frame: Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31
CL/F
Time frame: Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31
Effect of SRSD107 on circulating FXI Levels
Time frame: up to 168 days post last dose
Effect of SRSD107 on coagulation
Time frame: up to 168 days post last 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 18 May 2025.
- 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. This study is not recruiting at the moment.
Qiuyue Qu study director
Sirius Therapeutics Co., Ltd.
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 SRSD107 in people with Thrombosis, run by Sirius Therapeutics Co., Ltd. at 1 site in Australia.
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 5 inclusion and 17 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 18 May 2025. 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 Australia. 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?
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 18 May 2025.