Clinical trial NCT05294536: A Pharmacokinetic Study Comparing the Liraglutide Injection (RD12014) and Victoza® in Healthy Chinese Subjects
Official title: A Randomized, Open-label, Two-period, and Double-cross Comparative Study on the Pharmacokinetics of Liraglutide Injection (RD12014) and Victoza® in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-03-24
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Maximum (peak) plasma drug concentration(Cmax)
timeFrame: 0 hour（pre-dose,within 30mins） to 72 hours after administration
measure: Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
timeFrame: 0 hour（pre-dose,within 30mins） to 72 hours after administration
Secondary outcomes:
measure: Area under the plasma concentration-time curve from time zero to ∞ (AUC0-∞)
timeFrame: 0 hour（pre-dose,within 30mins） to infinity after administration
measure: Time to reach maximum plasma concentration following drug administration (Tmax)
timeFrame: 0 hour（pre-dose,within 30mins） to 72 hours after administration
measure: Elimination half-life (t1/2)
timeFrame: 0 hour（pre-dose,within 30mins） to 72 hours after administration
measure: Apparent total body clearance (CL/F)
timeFrame: 0 hour（pre-dose,within 30mins） to 72 hours after administration
measure: Apparent volume of distribution (Vd/F)
timeFrame: 0 hour（pre-dose,within 30mins） to 72 hours after administration
measure: Adverse Event, Serious Adverse Event
timeFrame: Up to day 4 after the second dose.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xuhui Central Hospital
state: Shanghai
Study officials:
References: