Clinical trial NCT06700083: A Safety, Tolerability, Pharmacokinetic Study of SHR-6934 Injection in Healthy Subjects
Official title: Safety, Tolerability, and Pharmacokinetics of Single and Multiple Subcutaneous Injections of SHR-6934 in Healthy Subjects: a Randomized, Double-blind, Dose-escalation, Placebo-controlled Phase I Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Heart Failure
Lead sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-11-21
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of subjects with adverse events (AEs)
timeFrame: Baseline up to 113 days after the last dosing
Secondary outcomes:
measure: Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration (AUC0-t) for SHR-6934
timeFrame: Baseline up to 113 days after the last dosing
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) for SHR-6934
timeFrame: Baseline up to 113 days after the last dosing
measure: Maximum plasma concentration (Cmax) for SHR-6934
timeFrame: Baseline up to 113 days after the last dosing
measure: Time to reach maximum plasma concentration (Tmax) for SHR-6934
timeFrame: Baseline up to 113 days after the last dosing
measure: Terminal half-life (t1/2) for SHR-6934
timeFrame: Baseline up to 113 days after the last dosing
measure: Apparent clearance (CL/F) of SHR-6934 for administration subcutaneously
timeFrame: Baseline up to 113 days after the last dosing
measure: Apparent volume of distribution (V/F) of SHR-6934 for administration subcutaneously
timeFrame: Baseline up to 113 days after the last dosing
measure: Proportion of anti-drug antibodies (ADA) positive subjects
timeFrame: Baseline up to 113 days after the last dosing
measure: Baseline and placebo-adjusted QTcF after SHR-6934
timeFrame: Baseline up to 15 days after dosing
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References: