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SSS55

Phase 1

Safety Issues | Small molecule | Other |Sunshine Biopharma Inc.|Last Updated: Mar 2, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

SSS55 · 1 trial · 1 indication

Phase 1 1
NCT07058779Safety, Tolerability, PK and PD of SSS55 in Healthy SubjectsSafety Issues
RECRUITING26 Analytics
PHASE1RECRUITING
Safety, Tolerability, PK and PD of SSS55 in Healthy Subjects
Safety Issues
NCT0705877926
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Study Endpoints

Primary Endpoints

To evaluate the safety and tolerability of a single intravenous infusion of SSS55 injection in healthy adult subjects in China
22days

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

Secondary Endpoints

To evaluate the pharmacokinetic (PK) characteristics of SSS55 injection after a single intravenous infusion in healthy adult subjects in China
22days
To evaluate the pharmacodynamic characteristics of SSS55 injection after a single intravenous infusion in healthy adult subjects in China
22 days
To evaluate the ADA of SSS55 injection after a single intravenous infusion in healthy adult subjects in China
22days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeOTHER

Treatment Arms

ArmTypeDescription
Low-dose groupEXPERIMENTALdose1
middle-dose groupEXPERIMENTALdose 2
high-dose groupEXPERIMENTALdose 3
Higher-dose groupEXPERIMENTALdose 4

Interventions

NameTypeDescription
SSS55DRUGSSS55 is an injection targeting complement C3b
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy subjects aged 18 to 45 years old (including the boundary value), regardless of gender; 2. The subjects voluntarily participated in the clinical trial and signed the informed consent form; 3. Men with a weight of ≥50 kg, women with a weight of ≥45 kg, and those with a ...

Countries:China
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Frequently asked questions about SSS55

What is SSS55 used for?

SSS55 is an investigational small molecule being developed by Sunshine Biopharma Inc. for safety issues. It is currently in Phase 1 clinical development, with a single trial evaluating its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy subjects. The drug is not yet approved and remains in clinical testing.

Who makes SSS55?

SSS55 is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker SBFM. The company is conducting a Phase 1 clinical trial of SSS55 in healthy volunteers to assess its safety and other pharmacological properties.

What phase is SSS55 in?

SSS55 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SSS55 in healthy subjects.

What clinical trials is SSS55 in?

SSS55 is being studied in one clinical trial, identified as NCT07058779, titled "Safety, Tolerability, PK and PD of SSS55 in Healthy Subjects." This Phase 1 trial is currently recruiting 26 participants in China, with a minimum age of 18 years, and is open to all sexes.

Is SSS55 being tested in healthy volunteers?

Yes, SSS55 is being tested in healthy volunteers. The Phase 1 clinical trial NCT07058779 is specifically designed to enroll healthy subjects aged 18 years and older. The study is randomized, double-blind, and controlled, with a total planned enrollment of 26 participants.