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HEC-151

Phase 1

Healthy Adult Male | Small molecule | Other |Sunshine Biopharma Inc.|Last Updated: Apr 29, 2026

Target and mechanism

ModalitySmall molecule

Also known as HEC-151 Injection

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment81

FDA Designations

No designations recorded

Clinical trial landscape

HEC-151 · 1 trial · 1 indication

Phase 1 1
NCT07376200Single-ascending Dose Study of HEC-151 InjectionHealthy Adult Male
RECRUITING81 Analytics
PHASE1RECRUITING
Single-ascending Dose Study of HEC-151 Injection
Healthy Adult MaleUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse event
From Day1 to Day36

Frequency, type and severity of adverse events/serious adverse events.

Electrocardiogram parameter(Heart rate)
From Day1 to Day36

Evaluation the heart rate of electrocardiogram parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.

Electrocardiogram parameter(PR interval)
From Day1 to Day36

Evaluation the PR interval of electrocardiogram parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.

Electrocardiogram parameter(QTcF interval)
From Day1 to Day36

Evaluation the QTcF interval of electrocardiogram parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.

Electrocardiogram parameter(QRS interval)
From Day1 to Day36

Evaluation the QRS interval of electrocardiogram parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.

Vital signs parameter(Body temperature)
From Day1 to Day36

Evaluation the body temperature of vital signs parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.

Vital signs parameter(Blood pressure)
From Day1 to Day36

Evaluation the blood pressure of vital signs parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.

Vital signs parameter(Pulse)
From Day1 to Day36

Evaluation the pulse of vital signs parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.

Vital signs parameter(Respiration)
From Day1 to Day36

Evaluation the respiration of vital signs parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.

Secondary Endpoints

Cmax
From Day1 to Day36
AUC0-t
From Day1 to Day36
Tmax
From Day1 to Day36
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
HEC-151 InjectionEXPERIMENTALThe participants received an abdominal subcutaneous HEC-151 Injection in the morning of Day 1.
Insulin DegludecACTIVE_COMPARATORThe participants received an abdominal subcutaneous injection of Insulin Degludec in the morning of Day 1.
PlaceboPLACEBO_COMPARATORThe participants received an abdominal subcutaneous Injection of placebo in the morning of Day 1.

Interventions

NameTypeDescription
HEC-151 InjectionDRUGSubcutaneous injection in the abdominal area
Degludec insulinDRUGSubcutaneous injection in the abdominal area
PlaceboDRUGSubcutaneous injection in the abdominal area
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: 1. Voluntarily participate in the trial and sign the informed consent form, understanding and abiding by the research procedures; 2. When signing the informed consent form, men aged 18-45 years old (including the boundary value) are eligible; 3. During the screening process, mal...

Countries:China
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Recent Changes (Last 90 Days)

LOWJul 5, 2026NCT07376200primaryCompletionDate: changed
LOWJul 5, 2026NCT07376200primaryCompletionDate: changed
LOWJul 5, 2026NCT07376200primaryCompletionDate: changed

Frequently asked questions about HEC-151

What is HEC-151?

HEC-151 is an investigational small molecule being developed by Sunshine Biopharma Inc. It is formulated as an injection and is currently in Phase 1 clinical development. The drug is being studied in healthy adult males, with its therapeutic area classified as other.

What is HEC-151 used for?

HEC-151 is being studied for use in healthy adult males as part of a Phase 1 clinical trial. The trial is a single-ascending dose study designed to evaluate the drug's effects in this population. The specific condition being investigated is healthy adult male volunteers.

Who makes HEC-151?

HEC-151 is being developed by Sunshine Biopharma Inc., a company traded under the ticker SBFM. The drug is currently in Phase 1 clinical development, with an active trial recruiting participants in China.

What phase is HEC-151 in?

HEC-151 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 a single-ascending dose study in healthy adult males, with 81 participants enrolled.

What clinical trials is HEC-151 in?

HEC-151 is being studied in a Phase 1 clinical trial with the identifier NCT07376200. The trial is titled "Single-ascending Dose Study of HEC-151 Injection" and is currently recruiting participants in China. It is a placebo-controlled, randomized study enrolling 81 healthy adult males aged 18 years and older.

Is HEC-151 the same as HEC-151 Injection?

Yes, HEC-151 is also known as HEC-151 Injection. The drug is administered as an injection and is being studied in a Phase 1 clinical trial under the name HEC-151 Injection. The trial is a single-ascending dose study in healthy adult males.