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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-30

Study Completion Date

2025-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SAD dose 1

Group Type EXPERIMENTAL

SHR-6934 injection

Intervention Type DRUG

SHR-6934 injection

SHR-6934 placebo

Intervention Type DRUG

SHR-6934 placebo

SAD dose 2

Group Type EXPERIMENTAL

SHR-6934 injection

Intervention Type DRUG

SHR-6934 injection

SHR-6934 placebo

Intervention Type DRUG

SHR-6934 placebo

SAD dose 3

Group Type EXPERIMENTAL

SHR-6934 injection

Intervention Type DRUG

SHR-6934 injection

SHR-6934 placebo

Intervention Type DRUG

SHR-6934 placebo

SAD dose 4

Group Type EXPERIMENTAL

SHR-6934 injection

Intervention Type DRUG

SHR-6934 injection

SHR-6934 placebo

Intervention Type DRUG

SHR-6934 placebo

SAD dose 5

Group Type EXPERIMENTAL

SHR-6934 injection

Intervention Type DRUG

SHR-6934 injection

SHR-6934 placebo

Intervention Type DRUG

SHR-6934 placebo

SAD dose 6

Group Type EXPERIMENTAL

SHR-6934 injection

Intervention Type DRUG

SHR-6934 injection

SHR-6934 placebo

Intervention Type DRUG

SHR-6934 placebo

MAD dose 1

Group Type EXPERIMENTAL

SHR-6934 injection

Intervention Type DRUG

SHR-6934 injection

SHR-6934 placebo

Intervention Type DRUG

SHR-6934 placebo

MAD dose 2

Group Type EXPERIMENTAL

SHR-6934 injection

Intervention Type DRUG

SHR-6934 injection

SHR-6934 placebo

Intervention Type DRUG

SHR-6934 placebo

MAD dose 3

Group Type EXPERIMENTAL

SHR-6934 injection

Intervention Type DRUG

SHR-6934 injection

SHR-6934 placebo

Intervention Type DRUG

SHR-6934 placebo

MAD dose 4

Group Type EXPERIMENTAL

SHR-6934 injection

Intervention Type DRUG

SHR-6934 injection

SHR-6934 placebo

Intervention Type DRUG

SHR-6934 placebo

Interventions

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SHR-6934 injection

Intervention Type DRUG

SHR-6934 placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. History of any clinically important disease or disorder;
2. 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;
3. 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;
4. Systolic blood pressure (SBP)≥140 mmHg or \<90 mmHg, diastolic blood pressure (DBP) ≥90 mmHg or \<60 mmHg;
5. Patients with orthostatic hypotension;
6. Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes