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HEC-007

Phase 1

Healthy Subjects | Small molecule | Other |Sunshine Biopharma Inc.|Last Updated: Apr 27, 2026

Target and mechanism

ModalitySmall molecule

Also known as HEC-007 injection

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment126

FDA Designations

No designations recorded

Clinical trial landscape

HEC-007 · 1 trial · 1 indication

Phase 1 1
NCT07102251A Study to Evaluate the Safety, Tolerability, PK/PD of HEC-007 Injection in Healthy and Overweight/Obese SubjectsHealthy Subjects
RECRUITING126 Analytics
PHASE1RECRUITING
A Study to Evaluate the Safety, Tolerability, PK/PD of HEC-007 Injection in Healthy and Overweight/Obese Subjects
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse events (AEs)
Screening period up to day 43/day 113
The maximum plasma concentration (Cmax)
Post-dose at day 1 to day 43/day 113
Time to maximum plasma concentration (Tmax)
Post-dose at day 1 to day 43/day 113
Terminal half-life (t1/2)
Post-dose at day 1 to day 43/day 113
Apparent clearance (CL/F)
Post-dose at day 1 to day 43/day 113
Apparent volume of distribution (Vz/F)
Post-dose at day 1 to day 43/day 113
Area Under the PlasmaConcentration-TimeCurve (AUC) of HEC-007
Post-dose at day 1 to day 43/day 113
Changes from baseline in Body Weight
Baseline period up to day 43/day 113
Changes from baseline in waist circumference
Baseline period up to day 43/day 113
Changes from baseline in Fasting Plasma Glucose
Baseline period up to day 43/day 113
Changes from baseline in Fasting Insulin
Baseline period up to day 43/day 113
Changes from baseline in fasting blood lipids
Baseline period up to day 43/day 113
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SAD Stage: HEC-007 InjectionEXPERIMENTALAdministered once
SAD Stage: PlaceboPLACEBO_COMPARATORAdministered once
MAD Stage: HEC-007 injectionEXPERIMENTALAdministered for multiple dose
MAD Stage: PlaceboPLACEBO_COMPARATORAdministered for multiple dose

Interventions

NameTypeDescription
HEC-007 injectionDRUGSingle dose escalation of HEC-007 injection in healthy subjects
PlaceboDRUGSingle dose of placebo in healthy adults
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: SAD 1. Subjects understand and comply with the study procedures, voluntarily participate, and sign the informed consent form. 2. Healthy adult subjects (including borderline values) aged 18 to 45 years, regardless of sex. 3. Male subjects weigh no less than 50 kg, and female su...

Countries:China
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Recent Changes (Last 90 Days)

LOWJul 5, 2026NCT07102251primaryCompletionDate: changed
LOWJul 5, 2026NCT07102251primaryCompletionDate: changed
LOWJul 5, 2026NCT07102251primaryCompletionDate: changed

Frequently asked questions about HEC-007

What is HEC-007 used for?

HEC-007 is an investigational small molecule being studied for use in healthy subjects, including overweight or obese individuals. It is currently in a Phase 1 clinical trial to evaluate its safety, tolerability, and pharmacokinetic and pharmacodynamic profiles. The drug is administered as an injection.

Who makes HEC-007?

HEC-007 is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker symbol SBFM. The company is conducting a Phase 1 clinical trial of HEC-007 injection in healthy and overweight or obese subjects in China.

What phase is HEC-007 in?

HEC-007 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess the safety, tolerability, and pharmacokinetic and pharmacodynamic properties of HEC-007 injection.

What clinical trials is HEC-007 in?

HEC-007 is being studied in a Phase 1 clinical trial with the identifier NCT07102251. The trial is titled 'A Study to Evaluate the Safety, Tolerability, PK/PD of HEC-007 Injection in Healthy and Overweight/Obese Subjects' and is currently recruiting participants in China. The study is randomized, double-blind, and placebo-controlled, with an enrollment of 126 subjects.

Is HEC-007 the same as HEC-007 injection?

Yes, HEC-007 and HEC-007 injection refer to the same drug. The injection formulation is the form being evaluated in clinical trials. The drug is administered via injection and is being studied in healthy and overweight or obese subjects.