Status:
COMPLETED
Single Ascending Dose Study of PCSK-9 Inhibitor (IBI306) in Healthy Subjects.
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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) ...
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 re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2018
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03366688
Start Date
November 27 2017
End Date
November 5 2018
Last Update
December 21 2020
Active Locations (1)
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1
Peking University First Hospital
Beijing, China