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

Beijing Suncadia Pharmaceuticals

Status and phase: Not yet enrolling; Phase 1

Conditions: Heart Failure

Treatments: Drug: SHR-6934 injection; Drug: SHR-6934 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06700083

SHR-6934-101

Details and patient eligibility

About

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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 10 patient groups

SAD dose 1

Experimental group

Treatment:

Drug: SHR-6934 placebo

Drug: SHR-6934 injection

SAD dose 2

Experimental group

Treatment:

Drug: SHR-6934 placebo

Drug: SHR-6934 injection

SAD dose 3

Experimental group

Treatment:

Drug: SHR-6934 placebo

Drug: SHR-6934 injection

SAD dose 4

Experimental group

Treatment:

Drug: SHR-6934 placebo

Drug: SHR-6934 injection

SAD dose 5

Experimental group

Treatment:

Drug: SHR-6934 placebo

Drug: SHR-6934 injection

SAD dose 6

Experimental group

Treatment:

Drug: SHR-6934 placebo

Drug: SHR-6934 injection

MAD dose 1

Experimental group

Treatment:

Drug: SHR-6934 placebo

Drug: SHR-6934 injection

MAD dose 2

Experimental group

Treatment:

Drug: SHR-6934 placebo

Drug: SHR-6934 injection

MAD dose 3

Experimental group

Treatment:

Drug: SHR-6934 placebo

Drug: SHR-6934 injection

MAD dose 4

Experimental group

Treatment:

Drug: SHR-6934 placebo

Drug: SHR-6934 injection