Bioequivalence Study of Tafolecimab Injections in Chinese Healthy Male Volunteers

Bioequivalence Study of Tafolecimab Injections Manufactured by Two Different Processes in Chinese Healthy Male Volunteers

This trial is conducted in China. The purpose of this study is to evaluate the pharmacokinetic similarity of Tafolecimab with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of sintilimab with different manufacturing process,also to determine Pharmacodynamics of Tafolecimab with different manufacturing process

Study Overview

• Status: Completed
• Conditions: Healthy Male Subjects
• Intervention / Treatment: Drug: tafolecimab (a modified manufacturing process); Drug: tafolecimab (a original manufacturing process)

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yang Yu; Phone Number: 0512-69566088; Email: yang.yu@innoventbio.com

Study Locations

• China
  • Beijing, China
    • Aerospace Center Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male subjects between 18 and 65 years of age, inclusive.
2. Low-density lipoprotein cholesterol (LDL-C) within the range of 1.8 mmol/L to 4.9 mmol/L, inclusive, at screening.
3. Body weight within the range of 63.0 kilograms (kg) to 75.0 kg, inclusive.
4. Subjects who are willing maintain current normal diet and physical activity.
5. Subjects agree to use reliable contraceptive measures (such as abstinence, sterilization, contraceptives, injectable contraceptive medroxyprogesterone or subcutaneous implant contraception, etc.) during the study period and within 6 months after the study drug infusion.
6. No history of serious diseases, including (but not limited to) cardiovascular, hepatic, renal, gastrointestinal, psychiatric, neurologic, endocrine, pulmonary, hematological, immune disease.
7. Subjects voluntarily signed the informed consent form and agreed to strictly follow the requirements of this protocol.

Exclusion Criteria:

1. Subjects who have a history of allergy, or may be allergic to the investigational drug and the related compounds.
2. Have used the inhibitors of proprotein convertase subtilisin type 9 (PCSK-9).
3. Have clinically relevant abnormalities identified by Vital signs, physical examination, clinical laboratory tests, 12-lead ECG, or chest X-ray, at screening.
4. Unwilling to stop any strenuous physical activity (such as weightlifting or long-distance running) within 72 hours before the planned follow-up visit.
5. History of hospitalization within 1 month before screening, major surgery within 6 months before screening, or other unstable conditions judged by the investigator.
6. The last dose of the previous investigational product which is chemical drug has been given in less than 1 month before administration.
7. The last dose of the previous investigational product which is biological drug has been given in less than 3 months before administration.
8. Have used any drugs (including over-the-counter drugs or prescription drugs), the last medication is less than 14 days or the last medication is less than 5 half-lives of the drug from the administration day (whichever is longer), or are using any drugs.
9. Have used any traditional Chinese medicines, vitamins or drugs or supplements known to affect lipid metabolism within 30 days before administration.
10. Have a positive test result of human immunodeficiency virus (Human Immunodeficiency Virus, HIV) antibody, hepatitis B virus surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or syphilis test at screening.
11. History of alcohol or drug abuse results within 12 months before screening. Average daily alcohol intake is more than 3 units of alcohol (male) (1 unit≈360mL beer, or 45mL spirits with 40% alcohol content, or 150mL wine), or unwilling to stop drinking 72 hours before administration and throughout the study period, or a positive ethanol breath test at screening, or positive drug screening results by urine at screening.
12. unable to abstain from smoking, alcohol and caffeinated beverages within 72 hours before administration and throughout the study period.
13. lost blood, donated blood ≥200 ml within 2 months before screening.
14. History of organ transplantation or malignant tumor.
15. Not suitable for this study in the investigator's opinion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tafolecimab (a modified manufacturing process); 450mg，SC，single dose	Drug: tafolecimab (a modified manufacturing process); 450mg，SC，single dose; Other Names: IBI306 (a modified manufacturing process)
Active Comparator: tafolecimab (a original manufacturing process); 450mg，SC，single dose	Drug: tafolecimab (a original manufacturing process); 450mg，SC，single dose; Other Names: IBI306 (a original manufacturing process)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioequivalence results using the peak serum drug concentration (Cmax) as the judging indicators	up to Day 57
Bioequivalence results using the area under the serum concentration-time curve (AUC0-inf) as the judging indicators	up to Day 57

Secondary Outcome Measures

Outcome Measure	Time Frame
Other PK parameters: Area under the plasma concentration-time curve (AUClast)	up to Day 57
Other PK parameters: Volume of distribution (V)	up to Day 57
Other PK parameters: elimination half-life (t1/2)	up to Day 57
Number of participants with adverse events, with abnormal vital signs, abnormal physical examination, abnormal laboratory test results and abnormal ECG readings	up to Day 57
The occurrence of Anti-drug Antibody(ADA)	up to Day 57
The occurrence of Neutralizing antibodies Antibody(NAb)	up to Day 57
Percentage Change from baseline in Low Density Lipoprotein choleterol (LDL-C)	up to Day 57
Percentage Change from baseline in Proprotein convertase subtilisin/kexin type 9(PCSK-9)	up to Day 57

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Actual): March 26, 2023
• Study Completion (Actual): August 4, 2023

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CIBI306K101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No