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

NCT ID: NCT05294536

Last Updated: 2022-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-22
• Study Completion Date: 2020-11-27

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liraglutide injection (RD12014)+ Victoza

Subjects receive liraglutide injection(RD12014) in the first cycle and Victoza in the second cycle.

Group Type: EXPERIMENTAL

Liraglutide injection,RD12014

Intervention Type: DRUG

single dose, s.c. injection

Liraglutide injection,Victoza

Intervention Type: DRUG

single dose, s.c. injection

Victoza + Liraglutide injection (RD12014)

Subjects receive Victoza in the first cycle and liraglutide injection(RD12014) in the second cycle.

Group Type: EXPERIMENTAL

Liraglutide injection,RD12014

Intervention Type: DRUG

single dose, s.c. injection

Liraglutide injection,Victoza

Intervention Type: DRUG

single dose, s.c. injection

Interventions

Liraglutide injection,RD12014

single dose, s.c. injection

Intervention Type: DRUG

Liraglutide injection,Victoza

single dose, s.c. injection

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sunshine Lake Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

Zhou R, Guo L, Gao X, Wang Y, Xu W, Zou Y, Li W, Zhuang Y, Liu G, Liu Y. A phase I study comparing the pharmacokinetics of the biosimilar (RD12014) with liraglutide (Victoza) in healthy Chinese male subjects. Clin Transl Sci. 2022 Oct;15(10):2458-2467. doi: 10.1111/cts.13374. Epub 2022 Jul 31.

Reference Type: DERIVED

PMID: 35871497 (View on PubMed)

Other Identifiers

12014-P-01/CRC-C1944

Identifier Type: -

Identifier Source: org_study_id