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HEC73077

Phase 1

Diabetic Nephropathy | Small molecule | Nephrology |Sunshine Biopharma Inc.|Trials Updated: Apr 12, 2023

HEC73077 target and mechanism

ModalitySmall molecule

Also known as HEC73077 tablets

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment138

FDA Designations

No designations recorded

HEC73077 clinical trials

HEC73077 · 1 trial · 1 indication

Phase 1 1
NCT05492630Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC73077 in Healthy SubjectsDiabetic Nephropathy
COMPLETED138 Analytics
PHASE1COMPLETED
Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC73077 in Healthy Subjects
Diabetic NephropathyUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse Events
Up to 19 days

Incidence of adverse events

Cmax
Day 1-17

Maximum plasma concentration of study drugs

AUC0-∞
Day 1-17

area under the concentration versus time curve (AUC) from time zero to infinity

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
HEC73077 tabletsEXPERIMENTALSingle-Dose Study: There will be a total of 7 dose cohorts. Multiple-dose Study: There will be a total of 4 dose cohorts.
HEC73077 placebo tabletsPLACEBO_COMPARATORSingle-Dose Study: There will be a total of 7 dose cohorts. Multiple-dose Study: There will be a total of 4 dose cohorts.

Interventions

NameTypeDescription
HEC73077 tabletsDRUGSingle-Dose Study: Each dose of HEC73077 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight. Multiple-dose study:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and/or multiple-dose study.
HEC73077 placebo tabletsDRUGSingle-Dose Study: Each dose of HEC73077 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight. Multiple-dose study:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and/or multiple-dose study.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions. 2. Be able to complete the study according to the trail protocol. 3. Subjects (including partners) have no pregnancy plan within 6 month...

Countries:China
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Competitive Landscape -Diabetic Nephropathy 12 trials

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Frequently asked questions about HEC73077

What is HEC73077?

HEC73077 is an investigational small molecule developed by Sunshine Biopharma Inc. (ticker SBFM) for diabetic nephropathy, a kidney complication of diabetes. It is in Phase 1 clinical development and has been studied in a completed Phase 1 trial in healthy subjects in China.

What is HEC73077 used for?

HEC73077 is being developed for diabetic nephropathy, a kidney condition that occurs in people with diabetes. It is an investigational therapy and has not been approved for any indication. Its clinical work to date has been in healthy volunteers rather than in patients with diabetic nephropathy.

Who makes HEC73077?

HEC73077 is developed by Sunshine Biopharma Inc., which trades under the ticker SBFM. The company is the sponsor behind the drug's clinical development program in diabetic nephropathy.

What phase is HEC73077 in?

HEC73077 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The program has not advanced beyond Phase 1, and the drug remains investigational for diabetic nephropathy.

What clinical trials is HEC73077 in?

HEC73077 has been evaluated in one completed Phase 1 trial, NCT05492630, titled a single and multiple dose safety, tolerability, PK and food effect study in healthy subjects. The trial enrolled 138 participants in China, was randomized, double blind, and placebo controlled, and included adults 18 years and older.

Is HEC73077 the same as HEC73077 tablets?

Yes, HEC73077 tablets refers to the same investigational drug as HEC73077. The tablet form is the oral formulation studied in the Phase 1 trial of the small molecule for diabetic nephropathy.