Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06116617




Registration number
NCT06116617
Ethics application status
Date submitted
30/10/2023
Date registered
3/11/2023
Date last updated
7/02/2024

Titles & IDs
Public title
A Phase 1 Study to Evaluate the Safety, Tolerability, PK/PD of SRSD107 in Healthy Participants
Scientific title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SRSD107 in Healthy Participants
Secondary ID [1] 0 0
SRSD107 101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thrombosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SRSD107
Treatment: Drugs - Placebo

Experimental: SRSD107 - 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 Group B1, 45mg per dose, 90mg multi dose Group B2, 120mg per dose, 240mg multi dose Group B3, 225mg per dose, 450mg multi dose

Placebo Comparator: Placebo - Sodium chloride for subcutaneous (s.c.) injection


Treatment: Drugs: SRSD107
SRSD107 is a synthetic, chemically modified double-stranded, small interfering ribonucleic acid (siRNA).

Treatment: Drugs: Placebo
Sodium chloride
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of adverse events (AEs)
Timepoint [1] 0 0
up to 168 days post last dose
Primary outcome [2] 0 0
Proportion of Serious Adverse Events (SAEs)
Timepoint [2] 0 0
up to 168 days post last dose
Secondary outcome [1] 0 0
Cmax
Timepoint [1] 0 0
Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31
Secondary outcome [2] 0 0
tmax
Timepoint [2] 0 0
Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31
Secondary outcome [3] 0 0
t1/2
Timepoint [3] 0 0
Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31
Secondary outcome [4] 0 0
AUC
Timepoint [4] 0 0
Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31
Secondary outcome [5] 0 0
CL/F
Timepoint [5] 0 0
Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31
Secondary outcome [6] 0 0
Effect of SRSD107 on circulating FXI Levels
Timepoint [6] 0 0
up to 168 days post last dose
Secondary outcome [7] 0 0
Effect of SRSD107 on coagulation
Timepoint [7] 0 0
up to 168 days post last dose

Eligibility
Key inclusion criteria
- 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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).

- 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Other (Non U.s.
Recruitment hospital [1] 0 0
Linear Clinical Research - Perth
Recruitment postcode(s) [1] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sirius Therapeutics Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to evaluate safety and tolerability data when SRSD107
is administered as single and multiple 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06116617
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Qiuyue Qu
Address 0 0
Sirius Therapeutics Co., Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Qiuyue Qu
Address 0 0
Country 0 0
Phone 0 0
+86 21 61207756
Fax 0 0
Email 0 0
medical@siriusrna.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06116617