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HECN30227

Phase 1

HBV Infection | Small molecule | Other |Sunshine Biopharma Inc.|Last Updated: Aug 18, 2026

Target and mechanism

ModalitySmall molecule

Also known as HECN30227 injection(SAD)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment78

FDA Designations

No designations recorded

Clinical trial landscape

HECN30227 · 1 trial · 1 indication

Phase 1 1
NCT07771140A Phase I Clinical Trial to Evaluate HECN30227 Injection in Healthy Subjects and Subjects With Chronic Hepatitis BHBV Infection
RECRUITING78 Analytics
PHASE1RECRUITING
A Phase I Clinical Trial to Evaluate HECN30227 Injection in Healthy Subjects and Subjects With Chronic Hepatitis B
HBV InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Adverse Events In Part 1
85 days

A summary of adverse events, including Serious Adverse Events(SAEs)

Number of Adverse Events In Part 2
169days

A summary of adverse events, including Serious Adverse Events(SAEs)

Secondary Endpoints

Peak Plasma Concentration (Cmax) of single dose
48 h
Peak Plasma Concentration (Cmax) of Multiple dose
57 days
Area under the plasma concentration-time curve(AUC0-t)
57 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
HECN30227 50~800 mgEXPERIMENTAL -
HECN30227 100~400 mgEXPERIMENTAL -

Interventions

NameTypeDescription
HECN30227 injection(SAD)DRUGsingle subcutaneous administrations
Placebo(MAD)DRUG0.9% Sodium Chloride Injection
Placebo(SAD)DRUG0.9% Sodium Chloride Injection
HECN30227 injection (MAD)DRUGmultiple subcutaneous administrations
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Subjects must understand and comply with the study procedures, voluntarily participate, and sign the informed consent form. 2. Male subjects must weigh at least 50 kg; female subjects must weigh at least 45 kg. 3. Vital signs, physical examination, laboratory tests, electroca...

Countries:China
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Frequently asked questions about HECN30227

What is HECN30227 used for?

HECN30227 is an investigational small molecule being developed for the treatment of HBV infection, specifically chronic hepatitis B. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes HECN30227?

HECN30227 is being developed by Sunshine Biopharma Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SBFM. The company is conducting clinical trials for this investigational drug candidate.

What phase is HECN30227 in?

HECN30227 is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The ongoing Phase 1 trial is recruiting participants to evaluate the drug's safety and tolerability.

What clinical trials is HECN30227 in?

HECN30227 is being evaluated in a Phase 1 clinical trial registered as NCT07771140. This randomized, double-blind, controlled study is recruiting healthy subjects and subjects with chronic hepatitis B in China, with a planned enrollment of 78 participants.

Is HECN30227 the same as HECN30227 injection(SAD)?

Yes, HECN30227 is also known as HECN30227 injection(SAD). The alternative name refers to the single ascending dose formulation of the drug being tested in the Phase 1 clinical trial.