A Phase 1 Study to Evaluate the Safety, Tolerability, PK/PD of SRSD107 in Healthy Participants

NCT06116617 | Completed Phase 1

• 1 other identifier: SRSD107-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thrombosis

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  up to 168 days post last dose

Secondary Outcomes (7)

• Cmax

  Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31

• tmax

  Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31

• t1/2

  Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31

• AUC

  Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31

• CL/F

  Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31

Study Arms (2)

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

Drug: SRSD107

Placebo

PLACEBO COMPARATOR

Sodium chloride for subcutaneous (s.c.) injection

Drug: Placebo

Interventions

SRSD107 DRUG

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

SRSD107

Placebo DRUG

Sodium chloride

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sirius Therapeutics Co., Ltd.: lead

Study Sites (1)

Linear Clinical Research

Perth, Other (Non U.s.), Australia

Location

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Qiuyue Qu

  Sirius Therapeutics Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 3, 2023
• Study Start: January 23, 2024
• Primary Completion: December 9, 2024
• Study Completion: April 30, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)