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Completed

NCT Number: NCT06700083

A Safety, Tolerability, Pharmacokinetic Study of SHR-6934 Injection in Healthy Subjects

This study was a randomized, double-blind, single-dose and multi-dose, placebo-controlled phase Ⅰ clinical trial. Six dose groups were planned for the SAD part of the study and four dose groups were planned for the MAD part. A total of 88 healthy subjects were included.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF);
  • Male or female aged 18-60;
  • Females must have a negative pregnancy test at the Screening Visit;
  • Body mass index (BMI) between 19 and 28 kg/m2;
  • Normal Electrocardiogram (ECG);
  • Men and women of childbearing potential must agree to take effective contraceptive methods.

Exclusion criteria

  • History of any clinically important disease or disorder;
  • History of drug or other allergies, or who, in the judgement of the investigator, may be allergic to the study drug or any component of the study drug;
  • Prior history of risk factors for Torsades de Pointes, such as unexplained syncope, definite long QT syndrome (including family history), heart failure, myocardial infarction, angina pectoris;
  • Systolic blood pressure (SBP)≥140 mmHg or <90 mmHg, diastolic blood pressure (DBP) ≥90 mmHg or <60 mmHg;
  • Patients with orthostatic hypotension;
  • Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.

Treatment and study plan

SHR-6934 injection

Drug

SHR-6934 injection

SHR-6934 placebo

Drug

SHR-6934 placebo

Primary outcomes

  1. Incidence of subjects with adverse events (AEs)

    Time frame: Baseline up to 113 days after the last dosing

Secondary outcomes

  1. Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration (AUC0-t) for SHR-6934

    Time frame: Baseline up to 113 days after the last dosing

  2. Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) for SHR-6934

    Time frame: Baseline up to 113 days after the last dosing

  3. Maximum plasma concentration (Cmax) for SHR-6934

    Time frame: Baseline up to 113 days after the last dosing

  4. Time to reach maximum plasma concentration (Tmax) for SHR-6934

    Time frame: Baseline up to 113 days after the last dosing

  5. Terminal half-life (t1/2) for SHR-6934

    Time frame: Baseline up to 113 days after the last dosing

  6. Apparent clearance (CL/F) of SHR-6934 for administration subcutaneously

    Time frame: Baseline up to 113 days after the last dosing

  7. Apparent volume of distribution (V/F) of SHR-6934 for administration subcutaneously

    Time frame: Baseline up to 113 days after the last dosing

  8. Proportion of anti-drug antibodies (ADA) positive subjects

    Time frame: Baseline up to 113 days after the last dosing

  9. Baseline and placebo-adjusted QTcF after SHR-6934

    Time frame: Baseline up to 15 days after dosing

Sponsors and collaborators

Lead sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd

Industry

Registry information

Official study title

Safety, Tolerability, and Pharmacokinetics of Single and Multiple Subcutaneous Injections of SHR-6934 in Healthy Subjects: a Randomized, Double-blind, Dose-escalation, Placebo-controlled Phase I Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2024
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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