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A Pharmacokinetic Study Comparing the 14028 Injection and TRULICITY® in Healthy Chinese Subjects
Pharmacokinetics, Safety and Immunogenicity of 14028 Injection Versus Dulaglutide Injection in Healthy Subjects: a Phase I ,Single-center, Randomized, Open-label, Single-dose, Parallel-controlled Clinical Study
Lead sponsor
Asset
Dulaglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
68
actual
Study population
Healthy volunteers
Key I/E criteria
•Male•Healthy volunteers
Primary endpoints
•Maximum (peak) plasma drug concentration(Cmax)•AUC
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Endpoints (8)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
8 endpointsMaximum (peak) plasma drug concentration(Cmax)
Time frame:0 hour (pre-dose,within 30mins) to 384 hours after administration
Cmax
concentration, descriptive
Area under the plasma concentration-time curve from time zero to ∞ (AUC0-∞)
Time frame:0 hour (pre-dose, within 30mins) to infinity
AUC₀–∞
concentration, descriptive
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
AUC₀–∞
concentration, descriptive
Time to reach maximum plasma concentration following drug administration (Tmax)
Time frame:0 hour (pre-dose,within 30mins) to 384 hours after administration
Tmax
descriptive
Elimination half-life (t1/2)
Time frame:0 hour (pre-dose,within 30mins) to 384 hours after administration
Half-life
descriptive
Apparent total body clearance (CL/F)
Time frame:0 hour (pre-dose,within 30mins) to 384 hours after administration
descriptive
Apparent volume of distribution (Vd/F)
Time frame:0 hour (pre-dose,within 30mins) to 384 hours after administration
descriptive
Elimination constants (λz)
Time frame:0 hour (pre-dose,within 30mins) to 384 hours after administration
descriptive
Publications (5)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Clinical and translational science2024 Apr (month)PMID38651744doi:10.1111/cts.13775via clinicaltrials gov reference derived + pubmed nct search
- Clinical pharmacokinetics2017 Nov (month)PMID28357715doi:10.1007/s40262-017-0531-7via CT.gov background
- Clinical pharmacokinetics2016 May (month)PMID26507721doi:10.1007/s40262-015-0338-3via CT.gov background
- Diabetes, obesity & metabolism2011 May (month)PMID21251179doi:10.1111/j.1463-1326.2011.01365.xvia CT.gov background
- Diabetes, obesity & metabolism2011 May (month)PMID21251178doi:10.1111/j.1463-1326.2011.01364.xvia CT.gov background
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.