Status:
COMPLETED
Multiple Ascending Dose Study of PCSK-9 Inhibitor (IBI306) in Chinese Patients With Hypercholesterolemia
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R)...
Detailed Description
A total of 60 patients who meet the criteria for admission and have a clinical diagnosis of hypercholesterolemia and have received statin for at least 4 weeks will be randomized and receive different ...
Eligibility Criteria
Inclusion
- Subjects must meet all of the following inclusion criteria in order to be included in the study:
- Provide a signed and dated informed consent form;
- Men or women with an age of 18 to 70 years of age at screening (Inclusive);
- BMI between18kg/m2 and 30kg/m2(Inclusive);
- Diagnosis of hyperlipidemia, and taking statins with moderate doses or above for at least 4 weeks;
- Fasting LDL-C between 100 mg / dl (2.6 mmol / L) and 220 mg / dl (5.7 mmol / L) at screening (Inclusive);
- Fasting triglycerides ≤ 400 mg (4.5 mmol / L) at screening.
Exclusion
- Subjects who do not meet any of the following exclusion criteria cannot be included in the study:
- Subject's current statin treatment are stable less than 4 weeks prior to random enrollment
- New York Heart Association (NYHA) III or IV heart failure, or last left ventricular ejection fraction \<30%
- Uncontrolled hypertension, defined as repeated measurements confirmed, sitting systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg.
- Diabetic patients have one of the following conditions;
- Known microvascular and macrovascular complications
- HbA1c\>7.5% within 4 weeks before screening
- Moderate or severe renal insufficiency, defined as the estimated glomerular filtration rate \<60 ml / min / 1.73 m2 during screening (calculated using the MDRD formula)
- Active liver disease or impaired liver function, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times the normal upper limit (ULN) at screening.
- Have previously undergone liver transplant surgery.
- Creatine kinase (CK) ≥ 3 times the upper limit of normal (ULN) at screening.
- At the discretion of the investigator, there are known active infections or major blood, kidney, metabolism, gastrointestinal or endocrine dysfunction.
- Female subject of childbearing potential not willing to use an acceptable method(s) of effective birth control during treatment with investigational product and for an additional 15 weeks after the end of treatment with investigational product. Male subjects are reluctant to inform their female sexual partners about their participation in the clinical study.
- Female subject is pregnant or breast feeding, planning to become pregnant or planning to breastfeed during treatment with investigational product and/or within 15 weeks after the end of treatment with investigational product..
- Subjects have been treated with PCSK9 inhibitors or have participated in other PCSK-9 inhibitor studies
- Subject has known sensitivity to the study drug and its excipients
- Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment (for example, alcohol or other substance abuse, unable or unwilling to comply with the agreement or mental illness).
- Currently receiving treatment in another investigational device or drug study, or less than 30 days before randomization since ending treatment on another investigational device or drug study(s) while participating in this study
- In the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
Key Trial Info
Start Date :
March 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 25 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03815812
Start Date
March 7 2019
End Date
December 25 2019
Last Update
November 18 2023
Active Locations (1)
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1
Peking University First Hospital
Beijing, China