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

NCT05294536 | Completed Phase 1

• 1 other identifier: 12014-P-01/CRC-C1944
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Maximum (peak) plasma drug concentration(Cmax)

  Maximum (peak) plasma drug concentration

  0 hour（pre-dose,within 30mins） to 72 hours after administration

• Area under the plasma concentration-time curve from time zero to time t (AUC0-t)

  The area under the plasma concentration curve from 0 to 72 h

  0 hour（pre-dose,within 30mins） to 72 hours after administration

Secondary Outcomes (6)

• Area under the plasma concentration-time curve from time zero to ∞ (AUC0-∞)

  0 hour（pre-dose,within 30mins） to infinity after administration

• Time to reach maximum plasma concentration following drug administration (Tmax)

  0 hour（pre-dose,within 30mins） to 72 hours after administration

• Elimination half-life (t1/2)

  0 hour（pre-dose,within 30mins） to 72 hours after administration

• Apparent total body clearance (CL/F)

  0 hour（pre-dose,within 30mins） to 72 hours after administration

• Apparent volume of distribution (Vd/F)

  0 hour（pre-dose,within 30mins） to 72 hours after administration

Study Arms (2)

Liraglutide injection (RD12014)+ Victoza

EXPERIMENTAL

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

Drug: Liraglutide injection,RD12014; Drug: Liraglutide injection,Victoza

Victoza + Liraglutide injection (RD12014)

EXPERIMENTAL

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

Drug: Liraglutide injection,RD12014; Drug: Liraglutide injection,Victoza

Interventions

Liraglutide injection,RD12014 DRUG

single dose, s.c. injection

Liraglutide injection (RD12014)+ Victoza; Victoza + Liraglutide injection (RD12014)

Liraglutide injection,Victoza DRUG

single dose, s.c. injection

Liraglutide injection (RD12014)+ Victoza; Victoza + Liraglutide injection (RD12014)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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;
• \. Aged between 18 and 45 years old of healthy male subjects ;
• \. Weight ≥50kg, and body mass index(BMI)= 19.0-26.0 kg/m2 ;
• \. No history of respiratory system, cardiovascular system, digestive system, urinary system, hematological system, endocrine system,nervous system or metabolic abnormalities;
• \. Normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, abdominal ultrasound examination and chest X-ray examination have no clinical significance;

You may not qualify if:

• \. Have a history of fainting needles, fainting blood;
• \. Positive for hepatitis (including hepatitis B and C), HIV or syphilis at screening;
• \. 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;
• \. Have a history of taken Liraglutide or other human glucagon-like peptides-1 analogues before the trial;
• \. Those who have been screened positive for drugs at screening;
• \. Donated blood (\> 400 ml) within 3 months before taking the study drug;
• \. Heavy smoker or those who smoked more than 10 cigarettes per day before taking the study drug.
• \. 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 ;
• \. Those who have been screened positive for drugs or have a history of drug abuse;
• \. Known allergy to Liraglutide or any of the excipients of the formulation;
• \. 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;
• \. Have participated in the drug clinical trial and taken the test drug within 3 months before taking the study drug;
• \. 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
• \. Other cases judged by researchers to be unsuitable for selection.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

Related Publications (1)

• 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.

  PMID: 35871497 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 24, 2022
• Study Start: June 22, 2020
• Primary Completion: July 20, 2020
• Study Completion: November 27, 2020
• Last Updated: March 24, 2022

Record last verified: 2022-03

Locations

CN (1)