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IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol(LDL-C)uptake. This is a randomized, double-blind, placebo-controlled,single ascending dose study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics and immunogenicity of IBI306 in healthy adults.
Ascending dose design includes 6 dose levels (25 mg, 75 mg, 150 mg, 300 mg, 450 mg and 600 mg). Tolerance and safety data up to 14 days after dosing from all subjects of the previous cohort will be reviewed before proceeding to the next dose. Total duration of the study per subject is 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI306 | Active Comparator | Subcutaneous or intravenous injection of a single dose of IBI306, dose level according to ascending dose design |
|
| placebo | Placebo Comparator | Subcutaneous or intravenous injection of a single dose of placebo, dose level according to ascending dose design |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI306 | Drug | Cohort 1: 25 mg Subcutaneous(SC) (this cohort is open label without placebo); Cohort 2: 75 mg SC; Cohort 3: 150 mg SC; Cohort 4: 75 mg IV; Cohort 5: 300 mg SC; Cohort 6: 450 mg SC; Cohort 7: 600 mg SC; Cohort 8: 450 mg IV. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events(AEs) as assessed by the criteria of National Institute on Aging | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The area under the curve (AUC) of serum concentration of the drug after the administration | up to 12 weeks | |
| Maximum concentration (Cmax) of the drug after the administration | up to 12 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | China |
Qualified researchers may request access to patient level data and related study documents including the study protocol with any amendments and statistical analysis plan. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| placebo | Drug | Cohort 2: 75 mg SC; Cohort 3: 150 mg SC; Cohort 4: 75 mg IV; Cohort 5: 300 mg SC; Cohort 6: 450 mg SC; Cohort 7: 600 mg SC; Cohort 8: 450 mg IV. |
|
| Time at which maximum concentration (Tmax) occurs for the drug after the administration |
| up to 12 weeks |
| The half-life (t1/2) of drug after the administration | up to 12 weeks |
| Assessment of serum concentrations of PCSK-9 | up to 12 weeks |
| Change from baseline in lipid parameters | up to 12 weeks |
| Number of participants with anti-drug antibodies or neutralizing antibodies | up to 12 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |