Current partner codePEPTIDESDE
NCT05459285·Phase 1·INTERVENTIONAL

A Pharmacokinetic Study Comparing the 14028 Injection and TRULICITY® in Healthy Chinese Subjects

Status

Completed

Phase

Phase 1

Enrollment

68

Locations

1

Results

Not posted

Publications

5

Study summary

What the protocol is testing.

To evaluate the pharmacokinetics similarity between the 14028 injection produced by Sunshine Lake Pharma Co., Ltd. and dulaglutide injection (TRULICITY®) produced by Eli Lilly and Company for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and immunogenicity between 14028 Injection and TRULICITY® in Healthy Subjects

Interventions

Treatment arms and agents.

BIOLOGICAL

14028 injection

14028 injection, single dose, s.c. injection

BIOLOGICAL

dulaglutide injection

dulaglutide injection(TRULICITY®), single dose, s.c. injection

Timeline

From registration to results.

  1. First posted

    Jul 14, 2022

  2. Study start

    May 31, 2022

  3. Primary completion

    Jul 2, 2022

  4. Study completion

    Jul 8, 2022

  5. Results posted

    Not reported

  6. Registry updated

    Aug 25, 2022

Outcomes

What the study measures.

Primary outcomes

Maximum (peak) plasma drug concentration(Cmax)

Time frame · 0 hour (pre-dose,within 30mins) to 384 hours after administration

Maximum (peak) plasma drug concentration

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

Time frame · 0 hour (pre-dose, within 30mins) to infinity

The area under the plasma concentration curve from 0 to ∞

Secondary outcomes

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

Time frame · 0 hour (pre-dose,within 30mins) to 384 hours after administration

The area under the plasma concentration curve from 0 to 384 h

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

Time frame · 0 hour (pre-dose,within 30mins) to 384 hours after administration

Time to maximum concentration

Elimination half-life (t1/2)

Time frame · 0 hour (pre-dose,within 30mins) to 384 hours after administration

Elimination half-life

Apparent total body clearance (CL/F)

Time frame · 0 hour (pre-dose,within 30mins) to 384 hours after administration

Apparent total body clearance

Apparent volume of distribution (Vd/F)

Time frame · 0 hour (pre-dose,within 30mins) to 384 hours after administration

Apparent volume of distribution

Elimination constants (λz)

Time frame · 0 hour (pre-dose,within 30mins) to 384 hours after administration

Elimination constants

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
45 Years
Sex
MALE
Healthy volunteers
Yes

Inclusion Criteria: 1. Sign the informed consent form before the trial, understand and comply with the research process, and participate the trial voluntarily 2. Healthy male subjects aged 18 to 45 (including the critical value) 3. Weight \> or = 50 kg, and 19.0 kg/m2 \< or = BMI (body mass index) \< or = 28.0 kg/m2 4. Vital signs, physical examination, laboratory examination, electrocardiogram, thyroid color Doppler ultrasound, abdominal color Doppler ultrasound and chest X-ray (anteroposterior) and other test results during screening are normal or have no clinical significance as judged by the investigator 5. Subjects agree to use effective contraceptive methods from signing the informed consent form to the end of the trial drug use within 3 months, and there is no sperm donation plan. Exclusion Criteria: 1. The investigator judges that the subjects have the following clinically significant diseases (including but not limited to gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases) 2. Have a medical or family history of medullary thyroid cancer (grandparents, parents, brothers and sisters), or a genetic disease that lead to medullary thyroid cancer; or a history or family history of multiple endocrine neoplasia syndrome type 2 3. Past or current history of pancreatitis (chronic or acute pancreatitis) 4. Past or current history of habitual constipation or intestinal obstruction 5. Clinically significant history of drug allergy or specific allergic disease (asthma, urticaria) or known allergy to the investigational drug and any component or related excipient components 6. Those who have difficulty with venous blood collection, a history of needle sickness, haemorrhage, or a known tendency to severe bleeding 7. Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), human immunodeficiency virus antibody (HIV), and Treponema pallidum antibody (TPAb) 8. Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, health products (except vitamin supplements) within 2 weeks before the first dose 9. Those who have a history of vaccination with live attenuated vaccine within 3 months before screening or a history of vaccination with inactivated vaccine within 1 month before screening 10. Those who have previously received dulaglutide or any other glucagon-like peptide-1 (GLP-1) analog 11. Those who donated blood or lost blood \> or = 400 mL within 3 months before screening, or those who plan to donate blood 12. Those who smoked more than 5 cigarettes per day within 3 months before screening or who could not give up smoking during the period from signing the informed consent to the subjects leaving the group 13. Those who have a history of alcohol abuse, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) , or those who have a positive alcohol breath test during the screening period 14. Those who have a history of drug abuse or poison use within 2 years before screening, or those who have a positive test results for urine drug abuse screening during the screening period 15. Participated in other clinical trials within 3 months before screening (subjects who are not randomized or not receiving treatment withdraw from the study before treatment, they can be enrolled in this study) 16. Acute illness or concomitant medication occurred from the time of signing the informed consent to the first administration 17. Those who have special requirements for diet and cannot obey the unified diet 18. Others judged by the investigator to be unsuitable to participate in this trial 19. Subjects who may not be able to complete this trial for other reasons

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

PKUCare Luzhong Hospital

Zibo, Shandong, China

Publications

Results and literature.

PMID 26507721Geiser JS, Heathman MA, Cui X, Martin J, Loghin C, Chien JY, de la Pena A. Clinical Pharmacokinetics of Dulaglutide in Patients with Type 2 Diabetes: Analyses of Data from Clinical Trials. Clin Pharmacokinet. 2016 May;55(5):625-34. doi: 10.1007/s40262-015-0338-3.PMID 21251179Barrington P, Chien JY, Tibaldi F, Showalter HD, Schneck K, Ellis B. LY2189265, a long-acting glucagon-like peptide-1 analogue, showed a dose-dependent effect on insulin secretion in healthy subjects. Diabetes Obes Metab. 2011 May;13(5):434-8. doi: 10.1111/j.1463-1326.2011.01365.x. Epub 2011 Jan 19.PMID 21251178Barrington P, Chien JY, Showalter HD, Schneck K, Cui S, Tibaldi F, Ellis B, Hardy TA. A 5-week study of the pharmacokinetics and pharmacodynamics of LY2189265, a novel, long-acting glucagon-like peptide-1 analogue, in patients with type 2 diabetes. Diabetes Obes Metab. 2011 May;13(5):426-33. doi: 10.1111/j.1463-1326.2011.01364.x. Epub 2011 Jan 19.PMID 28357715de la Pena A, Cui X, Geiser J, Loghin C. No Dose Adjustment is Recommended for Digoxin, Warfarin, Atorvastatin or a Combination Oral Contraceptive When Coadministered with Dulaglutide. Clin Pharmacokinet. 2017 Nov;56(11):1415-1427. doi: 10.1007/s40262-017-0531-7.PMID 38651744Gao X, Di Y, Lv Y, Luan Y, Xiong Y, Xu Y, Li Y, Guo L, Li X, Deng L, Zhuang Y, Hou J. A pharmacokinetic study comparing the biosimilar HEC14028 and Dulaglutide (Trulicity(R)) in healthy Chinese subjects. Clin Transl Sci. 2024 Apr;17(4):e13775. doi: 10.1111/cts.13775.

Primary links

Continue at the source.

Related trials

More studies on Dulaglutide.

Related PeptideStat pages

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