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CompletedPhase 1

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

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

68

actual

Study population

Healthy volunteers

Key I/E criteria

MaleHealthy 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

NCT IDNCT05459285
Org study ID14028-DM-101

Timeline

Milestones

Study start2022-05-31actual
Primary completion2022-07-02actual
Study completion2022-07-08actual
Study first posted2022-07-14actual
Last update posted2022-08-25actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexMale
Healthy volunteersAccepted

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 endpoints
Primary/protocol endpoint

Maximum (peak) plasma drug concentration(Cmax)

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

Cmax

concentration, descriptive

Primary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Elimination half-life (t1/2)

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

Half-life

descriptive

Secondary/protocol endpoint

Apparent total body clearance (CL/F)

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

descriptive

Secondary/protocol endpoint

Apparent volume of distribution (Vd/F)

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

descriptive

Secondary/protocol endpoint

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.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.