Active — Not RecruitingPhase 1

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

China72 participantsStarted 2025-01-06

Plain-language summary

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.

Who can participate

Age range18 Years – 60 Years

SexALL

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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.

What they're measuring

Incidence of subjects with adverse events (AEs)

Timeframe: Baseline up to 113 days after the last dosing

Trial details

NCT IDNCT06700083

SponsorBeijing Suncadia Pharmaceuticals Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08

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