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

NCT07655427 | Completed Phase 1

• 2 other identifiers: SRSD107-102ChiCTR2600120343
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Thrombus

Outcome Measures

Primary Outcomes (2)

• Proportion of adverse events (AEs)

  up to 168 days post last dose

• Proportion of Serious Adverse Events (SAEs)

  up to 168 days post last dose

Secondary Outcomes (9)

• Peak Concentration

  Day 1 to Day 3

• Time to maximum concentration

  Day1 to Day3

• Elimination half-life

  Day1 to Day3

• Area Under Curve

  Day1 to Day3

• Apparent total clearance

  Day1 to Day3

Study Arms (2)

SRSD107

EXPERIMENTAL

Drug: SRSD107

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SRSD107 DRUG

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

SRSD107

Placebo DRUG

Sodium chloride for subcutaneous injection.

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:

• 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.

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).
• 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.
• 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.

Sponsors & Collaborators

• Sirius Therapeutics Co., Ltd.: lead

Study Sites (1)

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 17, 2026
• Study Start: March 29, 2024
• Primary Completion: March 2, 2025
• Study Completion: March 2, 2025
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)