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14028

Phase 1

Type 2 Diabetes | Monoclonal antibody | Metabolic |Sunshine Biopharma Inc.|Trials Updated: Aug 25, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment68

FDA Designations

No designations recorded

14028 clinical trials

14028 · 1 trial · 1 indication

Phase 1 1
NCT05459285A Pharmacokinetic Study Comparing the 14028 Injection and TRULICITY® in Healthy Chinese SubjectsType 2 Diabetes
COMPLETED68 Analytics
PHASE1COMPLETED
A Pharmacokinetic Study Comparing the 14028 Injection and TRULICITY® in Healthy Chinese Subjects
Type 2 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum (peak) plasma drug concentration(Cmax)
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-∞)
0 hour (pre-dose, within 30mins) to infinity

The area under the plasma concentration curve from 0 to ∞

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
14028 injectionEXPERIMENTALSubjects receive 14028 injection in the study, 0.75mg, once
dulaglutide injection (TRULICITY®)ACTIVE_COMPARATORSubjects receive dulaglutide injection (TRULICITY®) in the study, 0.75mg, once

Interventions

NameTypeDescription
14028 injectionBIOLOGICAL14028 injection, single dose, s.c. injection
dulaglutide injectionBIOLOGICALdulaglutide injection(TRULICITY®), single dose, s.c. injection
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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) ...

Countries:China
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Frequently asked questions about 14028

What is 14028 used for?

14028 is an investigational monoclonal antibody being developed for Type 2 Diabetes. It is currently in Phase 1 clinical development and has completed one trial in healthy Chinese subjects. The drug is not approved and remains under investigation.

What does 14028 target?

14028 is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. The drug is being studied for its pharmacokinetic profile in comparison to an active control in healthy subjects.

Who makes 14028?

14028 is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker SBFM. The company is conducting clinical research on this investigational drug for Type 2 Diabetes.

What phase is 14028 in?

14028 is in Phase 1 clinical development. It has completed one Phase 1 trial, and no active trials are currently listed. The drug remains investigational and has not been approved for any use.

What clinical trials is 14028 in?

14028 has been studied in one completed Phase 1 trial, NCT05459285, titled 'A Pharmacokinetic Study Comparing the 14028 Injection and TRULICITY® in Healthy Chinese Subjects.' The trial enrolled 68 healthy male participants in China and was active-controlled.

Is 14028 the same as TRULICITY?

No, 14028 is not the same as TRULICITY. In the clinical trial NCT05459285, 14028 was compared against TRULICITY as an active control. TRULICITY is a separate, approved medication, while 14028 is an investigational monoclonal antibody.