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SSS39

Phase 1

Safety and Tolerability in Healthy Volunteers | Small molecule | Other |Sunshine Biopharma Inc.|Last Updated: Jul 10, 2025

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

SSS39 · 1 trial · 1 indication

Phase 1 1
NCT07057726A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSS39 Injection in Healthy Chinese SubjectsSafety and Tolerability in Healthy Volunteers
ENROLLING BY_INVITATION48 Analytics
PHASE1ENROLLING BY_INVITATION
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSS39 Injection in Healthy Chinese Subjects
Safety and Tolerability in Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the safety and tolerance of SSSS55
Day 50

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
group 1EXPERIMENTALLow-dose Group
group 2EXPERIMENTALhigh dose Group

Interventions

NameTypeDescription
SSS39DRUGSingle oral administration of SSS39
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * 1\. Healthy subjects aged 18-45 years old (including boundary values), regardless of gender; * 2\. Subjects voluntarily participate in clinical trials and sign informed consent; * 3\. Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) between 19-28 kg/m2 (includin...

Countries:China
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Frequently asked questions about SSS39

What is SSS39?

SSS39 is an investigational small molecule being developed by Sunshine Biopharma Inc. (NASDAQ: SBFM). It is currently in Phase 1 clinical development, with a study evaluating its safety, tolerability, and pharmacokinetics as an injection in healthy Chinese subjects.

What is SSS39 used for?

SSS39 is being studied for safety and tolerability in healthy volunteers. The ongoing Phase 1 trial is designed to evaluate the drug's safety, tolerability, and pharmacokinetics when administered as an injection, with a focus on healthy Chinese subjects.

Who makes SSS39?

SSS39 is being developed by Sunshine Biopharma Inc., a company publicly traded on NASDAQ under the ticker symbol SBFM. The company is conducting a Phase 1 clinical trial of SSS39 in healthy volunteers.

What phase is SSS39 in?

SSS39 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. A Phase 1 trial is currently enrolling participants by invitation to assess its safety, tolerability, and pharmacokinetics.

What clinical trials is SSS39 in?

SSS39 is being evaluated in a single Phase 1 clinical trial registered as NCT07057726. This randomized, double-blind, controlled study is enrolling 48 healthy Chinese subjects aged 18 years and older to assess the safety, tolerability, and pharmacokinetics of SSS39 injection.

Is SSS39 the same as any other drug?

SSS39 is a distinct investigational small molecule developed by Sunshine Biopharma Inc. No alternative names for SSS39 have been disclosed in the clinical trial registration. The drug is being studied under its current name in the ongoing Phase 1 trial.