A Pharmacokinetic Study Comparing the Liraglutide Injection (RD12014) and Victoza® in Healthy Chinese Subjects

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Liraglutide injection,RD12014; Drug: Liraglutide injection,Victoza

• Registration Number: NCT05294536
• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Brief Summary

To evaluate the pharmacokinetics similarity between the liraglutide injection (RD12014) produced by Sunshine Lake Pharma Co., Ltd. and liraglutide injection (Victoza®) produced by Novo Nordisk Pharmaceutical Co., Ltd for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and immunogenicity between RD12014 and Victoza ® in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-22
• Primary Completion: 2020-07-20
• Study Completion: 2020-11-27
• Status Verified: 2022-03
• Study First Submitted: 2022-03-10
• Study First Submitted QC: 2022-03-16
• Last Update Submitted: 2022-03-16
• Study First Posted: 2022-03-24
• Last Update Posted: 2022-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• 1. Being willing to participate in the experiment, fully understand and sign the informed consent, fully understand and able to complete the experiment according to the requirements of the experiment protocol;
• 2. Aged between 18 and 45 years old of healthy male subjects ;
• 3. Weight ≥50kg, and body mass index(BMI)= 19.0-26.0 kg/m2 ;
• 4. No history of respiratory system, cardiovascular system, digestive system, urinary system, hematological system, endocrine system,nervous system or metabolic abnormalities;
• 5. Normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, abdominal ultrasound examination and chest X-ray examination have no clinical significance;

Exclusion Criteria

• 1. Have a history of fainting needles, fainting blood;
• 2. Positive for hepatitis (including hepatitis B and C), HIV or syphilis at screening;
• 3. Have taken any prescription, over-the-counter, herbal medicine or health care products (other than normal vitamin products)within 2 weeks prior to the use of the study drug;
• 4. Have a history of taken Liraglutide or other human glucagon-like peptides-1 analogues before the trial;
• 5. Those who have been screened positive for drugs at screening;
• 6. Donated blood (> 400 ml) within 3 months before taking the study drug;
• 7. Heavy smoker or those who smoked more than 10 cigarettes per day before taking the study drug.
• 8. Alcohol abuse (drinking 21 units of alcohol per week: 1 unit = 360 ml of beer or 45 ml of 40% alcoholic spirits or 150 ml of wine) or positive for breath alcohol test ;
• 9. Those who have been screened positive for drugs or have a history of drug abuse;
• 10. Known allergy to Liraglutide or any of the excipients of the formulation;
• 11. Those who have a history or family history of medullary thyroid cancer (grandparents, parents and siblings), or inherited diseases that predispose them to medullary thyroid cancer;Or have a history or family history of multiple endocrine adenomatosis;
• 12. Have participated in the drug clinical trial and taken the test drug within 3 months before taking the study drug;
• 13. During the trial period and within 3 months after the last dose, those who want their female partners to become pregnant or is unwilling to use reliable contraceptive methods
• 14. Other cases judged by researchers to be unsuitable for selection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Liraglutide injection (RD12014)+ Victoza	Liraglutide injection,RD12014	Subjects receive liraglutide injection(RD12014) in the first cycle and Victoza in the second cycle.
Victoza + Liraglutide injection (RD12014)	Liraglutide injection,Victoza	Subjects receive Victoza in the first cycle and liraglutide injection(RD12014) in the second cycle.
Victoza + Liraglutide injection (RD12014)	Liraglutide injection,RD12014	Subjects receive Victoza in the first cycle and liraglutide injection(RD12014) in the second cycle.
Liraglutide injection (RD12014)+ Victoza	Liraglutide injection,Victoza	Subjects receive liraglutide injection(RD12014) in the first cycle and Victoza in the second cycle.

Primary Outcome Measures

Name	Time	Method
Maximum (peak) plasma drug concentration(Cmax)	0 hour（pre-dose,within 30mins） to 72 hours after administration	Maximum (peak) plasma drug concentration
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)	0 hour（pre-dose,within 30mins） to 72 hours after administration	The area under the plasma concentration curve from 0 to 72 h

Secondary Outcome Measures

Name	Time	Method
Area under the plasma concentration-time curve from time zero to ∞ (AUC0-∞)	0 hour（pre-dose,within 30mins） to infinity after administration	The area under the plasma concentration curve from 0 to ∞
Adverse Event, Serious Adverse Event	Up to day 4 after the second dose.	Monitor the safety indicators of subjects during the trial
Apparent total body clearance (CL/F)	0 hour（pre-dose,within 30mins） to 72 hours after administration	Apparent total body clearance
Elimination half-life (t1/2)	0 hour（pre-dose,within 30mins） to 72 hours after administration	Elimination half-life
Time to reach maximum plasma concentration following drug administration (Tmax)	0 hour（pre-dose,within 30mins） to 72 hours after administration	Time to maximum concentration
Apparent volume of distribution (Vd/F)	0 hour（pre-dose,within 30mins） to 72 hours after administration	Apparent volume of distribution

Trial Locations

Locations (1)

Shanghai Xuhui Central Hospital; 🇨🇳 Shanghai, Shanghai, China