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

Last updated: December 16, 2024
Sponsor: Sirius Therapeutics Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Thrombosis

Treatment

SRSD107

Placebo

Clinical Study ID

NCT06116617
SRSD107-101
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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, 12lead 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 andmales will agree to use contraception.

  • Able to understand and willing to sign an ICF and to abide by the studyrestrictions.

Exclusion

Exclusion Criteria:

  • Significant history or clinical manifestation of any metabolic, allergic,dermatological, hepatic, renal, hematological, pulmonary, cardiovascular,gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, asdetermined by the investigator (or designee).

  • History or evidence of any abnormal bleeding or coagulation disorder; or evidence ofcoagulopathy, prolonged or unexplained, clinically significant bleeding, or frequentunexplained bruising or thrombus formation; or a history of spontaneous bleeding.

  • Evidence of an active or suspected cancer, or a history of malignancy, within 5years prior to screening. Nonmelanoma skin cancer, curatively treated localizedprostate cancer, or other carcinoma in situ are not exclusionary, providing thatthey did not require systemic therapy and are considered cured.

  • Acute of febrile illness within 7 days prior to dose administration or evidence ofactive infection.

  • Any major surgery within 3 months prior to screening or plan to have any surgeryduring the study.

  • History of clinically significant hypersensitivity, intolerance, or allergy to anydrug compound, oligonucleotide, GalNAc, food, or other substance, as determined bythe 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 inmales or >470 ms in females confirmed by repeat measurement.

  • White blood cell count <3.5 × 109/L, platelets <100 × 109/L, or hemoglobin below thelower 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 2021Chronic 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 toscreening.

  • History of intolerance to SC injections, or scarring (eg, from surgical proceduresor burns) in areas when SC dose administration may occur.

  • Participants who, in the opinion of the investigator (or designee), should notparticipate in this study.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: SRSD107
Phase: 1
Study Start date:
January 23, 2024
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Linear Clinical Research

    Perth, Other (Non U.s.)
    Australia

    Site Not Available

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