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

NCT06700083 | Active Not Recruiting Phase 1

• 1 other identifier: SHR-6934-101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Incidence of subjects with adverse events (AEs)

  Baseline up to 113 days after the last dosing

Secondary Outcomes (9)

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

  Baseline up to 113 days after the last dosing

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

  Baseline up to 113 days after the last dosing

• Maximum plasma concentration (Cmax) for SHR-6934

  Baseline up to 113 days after the last dosing

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

  Baseline up to 113 days after the last dosing

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

  Baseline up to 113 days after the last dosing

Study Arms (10)

SAD dose 1

EXPERIMENTAL

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

SAD dose 2

EXPERIMENTAL

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

SAD dose 3

EXPERIMENTAL

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

SAD dose 4

EXPERIMENTAL

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

SAD dose 5

EXPERIMENTAL

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

SAD dose 6

EXPERIMENTAL

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

MAD dose 1

EXPERIMENTAL

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

MAD dose 2

EXPERIMENTAL

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

MAD dose 3

EXPERIMENTAL

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

MAD dose 4

EXPERIMENTAL

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

Interventions

SHR-6934 injection DRUG

SHR-6934 injection

MAD dose 1; MAD dose 2; MAD dose 3; MAD dose 4; SAD dose 1; SAD dose 2; SAD dose 3; SAD dose 4; SAD dose 5; SAD dose 6

SHR-6934 placebo DRUG

SHR-6934 placebo

MAD dose 1; MAD dose 2; MAD dose 3; MAD dose 4; SAD dose 1; SAD dose 2; SAD dose 3; SAD dose 4; SAD dose 5; SAD dose 6

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Suncadia Pharmaceuticals Co., Ltd: lead

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: January 6, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

CN (1)