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

NCT ID: NCT05459285

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2022-07-08

Brief Summary

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

Conditions

Type 2 Diabetes

Study Design

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

Study Groups

14028 injection

Subjects receive 14028 injection in the study, 0.75mg, once

Group Type: EXPERIMENTAL

14028 injection

Intervention Type: BIOLOGICAL

14028 injection, single dose, s.c. injection

dulaglutide injection (TRULICITY®)

Subjects receive dulaglutide injection (TRULICITY®) in the study, 0.75mg, once

Group Type: ACTIVE_COMPARATOR

dulaglutide injection

Intervention Type: BIOLOGICAL

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

Interventions

14028 injection

14028 injection, single dose, s.c. injection

Intervention Type: BIOLOGICAL

dulaglutide injection

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

Intervention Type: BIOLOGICAL

Other Intervention Names

TRULICITY®

Eligibility Criteria

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

• 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

Principal Investigators

Jie Hou, doctor

Role: PRINCIPAL_INVESTIGATOR

Peking University Care Luzhong Hospital

Hong Wang, bachelor

Role: PRINCIPAL_INVESTIGATOR

Peking University Care Luzhong Hospital

Locations

PKUCare Luzhong Hospital

Zibo, Shandong, China

Countries

China

References

IDF (International Diabetes Federation) Diabetes Atlas, ninth edition, 2019.

Reference Type: BACKGROUND

EMA. Trulicity® Risk Management Plan.2021.01.02.

Reference Type: BACKGROUND

Geiser 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.

Reference Type: BACKGROUND

PMID: 26507721 (View on PubMed)

FDA. Guidance for Industry - Clinical pharmacology data to support a demonstration of biosimilarity to a reference product. Dec. 2016.

Reference Type: BACKGROUND

Barrington 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.

Reference Type: BACKGROUND

PMID: 21251179 (View on PubMed)

Barrington 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.

Reference Type: BACKGROUND

PMID: 21251178 (View on PubMed)

de 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.

Reference Type: BACKGROUND

PMID: 28357715 (View on PubMed)

FDA (Food Drug Administration), Clinical Pharmacology Biopharmaceutics Review(s), 2014.

Reference Type: BACKGROUND

EMA (European Medicines Agency), Public assessment report.2014

Reference Type: BACKGROUND

Gao 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.

Reference Type: DERIVED

PMID: 38651744 (View on PubMed)

Other Identifiers

14028-DM-101

Identifier Type: -

Identifier Source: org_study_id