Back to resultsSingle Ascending Dose Study of PCSK-9 Inhibitor (IBI306) in Healthy Subjects.
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IBI306
placebo
Sponsored by
About this trial
This is an interventional other trial for Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- Chinese healthy men or women aged 18 to 55 years old at screening (inclusive）;
- Serum LDL-C concentration between 1.8 mmol/L and 4.9 mmol/L (inclusive）at screening;
- Body mass index between 19 and 28 kg/m2 (inclusive);
- Willing to maintain the current regular diet and physical activity;
- Female subjects and male subject's partner who could become pregnant should take effective contraceptions during the treatment period and 6 months after dosing;
- Without any medical history of serious diseases;
- Willing to comply with protocol required visit schedule and visit requirements and provide written informed consent.
Exclusion Criteria:
- Breast-feeding or pregnant women;
- History of allergic reaction;
- Previously received any anti-PCSK-9 treatment;
- Vital signs, physical examination, clinical laboratory test, 12-lead ECG, and chest X-ray are abnormal with clinical significance;
- Not willing to stop intense physical activities (such as weight lifting or long-distance running) before 72 hours of the scheduled visits;
- Any hospitalization within one month before screening, or major surgery within six months before screening, or any other unstable medical condition;
- Received an investigational chemical agent within 30 days before dosing；
- Received an investigational biological agent within 90 days before dosing；
- Use of medications including over-the-counter medication within 14 days or less than 5 half-lifes of the agent;
- Use of herb,vitamins or nutraceutical in order to alter serum lipids;
- Positive screen of hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus or syphilis infection at screening；
- History or clinical evidence of alcohol or drugs of abuse within 12 months before screening;
- With any consumption of alcohol and caffeinated beverages within 72 hours prior to and during the trial;
- Blood donations or blood loss 200 ml and more within 2 months before screening;
- History of organ transplantation or malignant tumor;
- Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment.
Sites / Locations
- Peking University First Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
IBI306
placebo
Arm Description
Subcutaneous or intravenous injection of a single dose of IBI306, dose level according to ascending dose design
Subcutaneous or intravenous injection of a single dose of placebo, dose level according to ascending dose design
Outcomes
Primary Outcome Measures
Number of participants with adverse events（AEs) as assessed by the criteria of National Institute on Aging
Secondary Outcome Measures
The area under the curve (AUC) of serum concentration of the drug after the administration
Maximum concentration (Cmax) of the drug after the administration
Time at which maximum concentration (Tmax) occurs for the drug after the administration
The half-life (t1/2) of drug after the administration
Assessment of serum concentrations of PCSK-9
Change from baseline in lipid parameters
Number of participants with anti-drug antibodies or neutralizing antibodies
Full Information
NCT ID
NCT03366688
First Posted
November 27, 2017
Last Updated
December 17, 2020
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03366688
Brief Title
Single Ascending Dose Study of PCSK-9 Inhibitor (IBI306) in Healthy Subjects.
Official Title
A Randomized, Double Blind, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of IBI306 in Healthy Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
November 27, 2017 (Actual)
Primary Completion Date
November 5, 2018 (Actual)
Study Completion Date
November 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IBI306
Arm Type
Active Comparator
Arm Description
Subcutaneous or intravenous injection of a single dose of IBI306, dose level according to ascending dose design
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Subcutaneous or intravenous injection of a single dose of placebo, dose level according to ascending dose design
Intervention Type
Drug
Intervention Name(s)
IBI306
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with adverse events（AEs) as assessed by the criteria of National Institute on Aging
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
The area under the curve (AUC) of serum concentration of the drug after the administration
Time Frame
up to 12 weeks
Title
Maximum concentration (Cmax) of the drug after the administration
Time Frame
up to 12 weeks
Title
Time at which maximum concentration (Tmax) occurs for the drug after the administration
Time Frame
up to 12 weeks
Title
The half-life (t1/2) of drug after the administration
Time Frame
up to 12 weeks
Title
Assessment of serum concentrations of PCSK-9
Time Frame
up to 12 weeks
Title
Change from baseline in lipid parameters
Time Frame
up to 12 weeks
Title
Number of participants with anti-drug antibodies or neutralizing antibodies
Time Frame
up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Chinese healthy men or women aged 18 to 55 years old at screening (inclusive）;
Serum LDL-C concentration between 1.8 mmol/L and 4.9 mmol/L (inclusive）at screening;
Body mass index between 19 and 28 kg/m2 (inclusive);
Willing to maintain the current regular diet and physical activity;
Female subjects and male subject's partner who could become pregnant should take effective contraceptions during the treatment period and 6 months after dosing;
Without any medical history of serious diseases;
Willing to comply with protocol required visit schedule and visit requirements and provide written informed consent.
Exclusion Criteria:
Breast-feeding or pregnant women;
History of allergic reaction;
Previously received any anti-PCSK-9 treatment;
Vital signs, physical examination, clinical laboratory test, 12-lead ECG, and chest X-ray are abnormal with clinical significance;
Not willing to stop intense physical activities (such as weight lifting or long-distance running) before 72 hours of the scheduled visits;
Any hospitalization within one month before screening, or major surgery within six months before screening, or any other unstable medical condition;
Received an investigational chemical agent within 30 days before dosing；
Received an investigational biological agent within 90 days before dosing；
Use of medications including over-the-counter medication within 14 days or less than 5 half-lifes of the agent;
Use of herb,vitamins or nutraceutical in order to alter serum lipids;
Positive screen of hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus or syphilis infection at screening；
History or clinical evidence of alcohol or drugs of abuse within 12 months before screening;
With any consumption of alcohol and caffeinated beverages within 72 hours prior to and during the trial;
Blood donations or blood loss 200 ml and more within 2 months before screening;
History of organ transplantation or malignant tumor;
Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment.
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Learn more about this trial
Single Ascending Dose Study of PCSK-9 Inhibitor (IBI306) in Healthy Subjects.
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