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

NCT03366688 | Completed Phase 1

• 1 other identifier: CIBI306A101
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events（AEs) as assessed by the criteria of National Institute on Aging

  up to 12 weeks

Secondary Outcomes (7)

• 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

• 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

Study Arms (2)

IBI306

ACTIVE COMPARATOR

Subcutaneous or intravenous injection of a single dose of IBI306, dose level according to ascending dose design

Drug: IBI306

placebo

PLACEBO COMPARATOR

Subcutaneous or intravenous injection of a single dose of placebo, dose level according to ascending dose design

Drug: placebo

Interventions

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.

IBI306

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.

placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Peking University First Hospital

Beijing, China

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 8, 2017
• Study Start: November 27, 2017
• Primary Completion: November 5, 2018
• Study Completion: November 5, 2018
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (1)