Single Ascending Dose Study of PCSK-9 Inhibitor (IBI306) in Healthy Subjects.

• Status: Completed
• Trial end date: 2018-11-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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.