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

Phase 1

Not yet recruiting

• Conditions: Heart Failure
• Interventions: Drug: SHR-6934 injection; Drug: SHR-6934 placebo

• Registration Number: NCT06700083
• Lead Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-21
• Last Update Posted: 2024-11-21
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 88

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MAD dose 4	SHR-6934 placebo	-
SAD dose 1	SHR-6934 injection	-
SAD dose 1	SHR-6934 placebo	-
SAD dose 2	SHR-6934 injection	-
SAD dose 2	SHR-6934 placebo	-
SAD dose 3	SHR-6934 injection	-
SAD dose 3	SHR-6934 placebo	-
SAD dose 4	SHR-6934 injection	-
SAD dose 4	SHR-6934 placebo	-
SAD dose 5	SHR-6934 injection	-
SAD dose 5	SHR-6934 placebo	-
SAD dose 6	SHR-6934 injection	-
SAD dose 6	SHR-6934 placebo	-
MAD dose 1	SHR-6934 injection	-
MAD dose 1	SHR-6934 placebo	-
MAD dose 2	SHR-6934 injection	-
MAD dose 2	SHR-6934 placebo	-
MAD dose 3	SHR-6934 injection	-
MAD dose 3	SHR-6934 placebo	-
MAD dose 4	SHR-6934 injection	-

Primary Outcome Measures

Name	Time	Method
Incidence of subjects with adverse events (AEs)	Baseline up to 113 days after the last dosing

Secondary Outcome Measures

Name	Time	Method
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
Apparent clearance (CL/F) of SHR-6934 for administration subcutaneously	Baseline up to 113 days after the last dosing
Apparent volume of distribution (V/F) of SHR-6934 for administration subcutaneously	Baseline up to 113 days after the last dosing
Proportion of anti-drug antibodies (ADA) positive subjects	Baseline up to 113 days after the last dosing
Baseline and placebo-adjusted QTcF after SHR-6934	Baseline up to 15 days after dosing

Trial Locations

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China