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

B

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

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

Trial contacts and locations

1

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Central trial contact

Sheng Feng, M.M

Data sourced from clinicaltrials.gov

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