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SSS67

Phase 1

Healthy | Small molecule | Other |Sunshine Biopharma Inc.|Last Updated: Mar 23, 2026

Target and mechanism

ModalitySmall molecule

Also known as SSS67 Injection

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

SSS67 · 1 trial · 1 indication

Phase 1 1
NCT07487545Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of SSS67 in Healthy Adult Participants Via Single Intravenous InfusionHealthy
NOT YET_RECRUITING52 Analytics
PHASE1NOT YET_RECRUITING
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of SSS67 in Healthy Adult Participants Via Single Intravenous Infusion
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence and severity of AEs
Day 57

Secondary Endpoints

Peak concentration
Day 57
Incidence of antidrug antibodies (ADAs) to SSS67 over time
Day 57
Bone formation biomarker
Day 57
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SSS67 1mg/kgEXPERIMENTALThis is a single-dose group. 2 participants will be enrolled and receive a single intravenous infusion of SSS67 at 1 mg/kg on Day 1. No placebo is administered in this group.
SSS67 5mg/kg+PlaceboEXPERIMENTALThis is a single-dose group. 10 participants will be enrolled: 8 receive a single intravenous infusion of SSS67 at 5 mg/kg on Day 1, and 2 receive matching placebo on Day 1.
SSS67 15mg/kg+PlaceboEXPERIMENTALThis is a single-dose group. 10 participants will be enrolled: 8 receive a single intravenous infusion of SSS67 at 15 mg/kg on Day 1, and 2 receive matching placebo on Day 1.
SSS67 30mg/kg+PlaceboEXPERIMENTALThis is a single-dose group. 10 participants will be enrolled: 8 receive a single intravenous infusion of SSS67 at 30 mg/kg on Day 1, and 2 receive matching placebo on Day 1.
SSS67 45mg/kg+PlaceboEXPERIMENTALThis is a single-dose group. 10 participants will be enrolled: 8 receive a single intravenous infusion of SSS67 at 45 mg/kg on Day 1, and 2 receive matching placebo on Day 1.
SSS67 60mg/kg+PlaceboEXPERIMENTALThis is a single-dose group. 10 participants will be enrolled: 8 receive a single intravenous infusion of SSS67 at 60 mg/kg on Day 1, and 2 receive matching placebo on Day 1.

Interventions

NameTypeDescription
SSS67 InjectionDRUGIn this Phase 1 single ascending dose trial, SSS67 Injection will be administered via intravenous infusion.
PlaceboDRUGParticipants will receive a single dose of matching placebo in accordance with their randomly assigned treatment group.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Participants aged 18 to 65 years (inclusive), regardless of gender. * Participate in the clinical trial voluntarily and provide informed consent form. * At screening, body weight ≥ 50 kg for males and ≥ 45 kg for females. Body Mass Index (BMI) must be between 18.5 and 32 kg/m²...

Countries:AustraliaChina
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Frequently asked questions about SSS67

What is SSS67 used for?

SSS67 is an investigational small molecule being studied in healthy adult participants. It is administered as a single intravenous infusion. The drug is currently in Phase 1 clinical development, and its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity are being evaluated in a clinical trial.

Who makes SSS67?

SSS67 is being developed by Sunshine Biopharma Inc., a company traded under the ticker symbol SBFM. The company is conducting a Phase 1 clinical trial to evaluate the drug in healthy participants.

What phase is SSS67 in?

SSS67 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial is currently planned to assess its safety, tolerability, and other characteristics in healthy adult participants.

What clinical trials is SSS67 in?

SSS67 is involved in one clinical trial with the identifier NCT07487545. The trial is titled 'Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of SSS67 in Healthy Adult Participants Via Single Intravenous Infusion.' It is a Phase 1, randomized, double-blind, controlled study with an enrollment of 52 participants.

Is SSS67 the same as SSS67 Injection?

Yes, SSS67 is also known as SSS67 Injection. The drug is administered as a single intravenous infusion, and the alternative name reflects its formulation as an injectable product.