Recent Updates
Recently added Catalysts

HEC73077

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment138

FDA Designations

No designations recorded

Clinical trial landscape

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

Unlock Study Endpoints

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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

Competitive Landscape -Diabetic Nephropathy 8 trials

Frequently asked questions about HEC73077

What is HEC73077 used for?

HEC73077 is an investigational small molecule being developed for diabetic nephropathy, a kidney condition that can occur in people with diabetes. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes HEC73077?

HEC73077 is being developed by Sunshine Biopharma Inc., a biopharmaceutical company traded on the stock market under the ticker symbol SBFM. The company is conducting clinical research on this investigational drug for diabetic nephropathy.

What phase is HEC73077 in?

HEC73077 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not been approved for any use, and further clinical studies would be needed to assess its safety and efficacy.

What clinical trials is HEC73077 in?

HEC73077 has one completed Phase 1 clinical trial registered as NCT05492630, titled "Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC73077 in Healthy Subjects." The trial enrolled 138 participants in China and was a randomized, double-blind, placebo-controlled study.

Is HEC73077 FDA approved?

No, HEC73077 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for diabetic nephropathy. The completed Phase 1 trial was conducted in healthy volunteers to evaluate safety, tolerability, pharmacokinetics, and food effects.