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

NCT05459285 | Completed Phase 1

• 1 other identifier: 14028-DM-101
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Maximum (peak) plasma drug concentration(Cmax)

  Maximum (peak) plasma drug concentration

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

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

  The area under the plasma concentration curve from 0 to ∞

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

Secondary Outcomes (6)

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

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

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

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

• Elimination half-life (t1/2)

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

• Apparent total body clearance (CL/F)

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

• Apparent volume of distribution (Vd/F)

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

Study Arms (2)

14028 injection

EXPERIMENTAL

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

Biological: 14028 injection

dulaglutide injection (TRULICITY®)

ACTIVE COMPARATOR

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

Biological: dulaglutide injection

Interventions

14028 injection BIOLOGICAL

14028 injection, single dose, s.c. injection

14028 injection

dulaglutide injection BIOLOGICAL

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

Also known as: TRULICITY®

dulaglutide injection (TRULICITY®)

Eligibility Criteria

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

You may qualify if:

• Sign the informed consent form before the trial, understand and comply with the research process, and participate the trial voluntarily
• Healthy male subjects aged 18 to 45 (including the critical value)
• Weight \> or = 50 kg, and 19.0 kg/m2 \< or = BMI (body mass index) \< or = 28.0 kg/m2
• 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
• 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.

You may not qualify if:

• 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)
• 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
• Past or current history of pancreatitis (chronic or acute pancreatitis)
• Past or current history of habitual constipation or intestinal obstruction
• 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
• Those who have difficulty with venous blood collection, a history of needle sickness, haemorrhage, or a known tendency to severe bleeding
• Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), human immunodeficiency virus antibody (HIV), and Treponema pallidum antibody (TPAb)
• 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
• 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
• Those who have previously received dulaglutide or any other glucagon-like peptide-1 (GLP-1) analog
• Those who donated blood or lost blood \> or = 400 mL within 3 months before screening, or those who plan to donate blood
• 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
• 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
• 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
• 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)

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

PKUCare Luzhong Hospital

Zibo, Shandong, 255400, China

Location

Related Publications (10)

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

  BACKGROUND

• EMA. Trulicity® Risk Management Plan.2021.01.02.

  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.

  PMID: 26507721 BACKGROUND

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

  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.

  PMID: 21251179 BACKGROUND

• 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.

  PMID: 21251178 BACKGROUND

• 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.

  PMID: 28357715 BACKGROUND

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

  BACKGROUND

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

  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.

  PMID: 38651744 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide

Condition Hierarchy (Ancestors)

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

Study Officials

• Jie Hou, doctor

  Peking University Care Luzhong Hospital

  PRINCIPAL INVESTIGATOR

• Hong Wang, bachelor

  Peking University Care Luzhong Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 14, 2022
• Study Start: May 31, 2022
• Primary Completion: July 2, 2022
• Study Completion: July 8, 2022
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)