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SD-101

Phase 1

Chronic Hepatitis C | Small molecule | Infectious Disease |Dynavax Technologies Corporation|Last Updated: Apr 16, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

SD-101 · 2 trials · 2 indications

Phase 1 2
NCT00823862Safety Study of SD-101 (a Novel C Type Toll-like Receptor 9 (TLR9) Agonist) for the Treatment of Chronic Hepatitis C Virus (HCV) InfectionChronic Hepatitis C
COMPLETED34 Analytics
NCT00599001Safety, Pharmacokinetics, and Pharmacodynamics of SD-101 in Healthy Normal MalesHealthy
COMPLETED26 Analytics
PHASE1COMPLETED
Safety Study of SD-101 (a Novel C Type Toll-like Receptor 9 (TLR9) Agonist) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection
Chronic Hepatitis C
NCT0082386234
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PHASE1COMPLETED
Safety, Pharmacokinetics, and Pharmacodynamics of SD-101 in Healthy Normal Males
Healthy
NCT0059900126
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Study Endpoints

Primary Endpoints

Adverse event timing, duration, and severity.
Between doses and up to 3 months after last dose
Proportion of subjects with and the amplitude and timing of adverse events, proportion of subjects with and the grade and timing of abnormal lab values, and proportion of subjects with and timing of changes in physical exam findings and vital signs
Up to 7 days after dosing

Secondary Endpoints

Biomarker analysis of blood sample
pre and 24 hour post dose
Viral load in blood sample
each visit
Pharmacokinetic parameters
Up to 24 hours after dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Active (SD-101)EXPERIMENTALSD-101 in cohorts of escalating doses
Escalating Dose of SD-101EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
SD-101DRUGIntramuscular (IM)
ribavirinDRUGoral, 2 times per day, for 2 months
placeboDRUGplacebo
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Signed, written, informed consent * Male or female subjects, 18 to 55 years of age. * Subject must have chronic infection HCV, genotype 1. * Serum HCV-RNA concentrations 100,000 IU/mL to 10,000,000 IU/mL * No prior treatment for HCV. * Must be negative for hepatitis B (HBV) an...

Countries:PolandUnited States
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Frequently asked questions about SD-101

What is SD-101 used for?

SD-101 is an investigational small molecule being studied for the treatment of Chronic Hepatitis C. It has also been evaluated in healthy volunteers to assess its safety, pharmacokinetics, and pharmacodynamics. The drug is in Phase 1 clinical development and is not yet approved for any use.

What does SD-101 target?

SD-101 is a novel C-type Toll-like receptor 9 (TLR9) agonist. It targets TLR9, a receptor involved in the immune response, which may help in treating Chronic Hepatitis C by modulating the body's immune system.

Who makes SD-101?

SD-101 is being developed by Dynavax Technologies Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol DVAX. The company is conducting clinical trials to evaluate the drug's safety and efficacy.

What phase is SD-101 in?

SD-101 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Two Phase 1 trials have been completed, one in healthy volunteers and one in patients with Chronic Hepatitis C.

What clinical trials is SD-101 in?

SD-101 has been studied in two completed Phase 1 clinical trials. The first, NCT00599001, evaluated safety, pharmacokinetics, and pharmacodynamics in healthy males. The second, NCT00823862, assessed safety in patients with Chronic Hepatitis C. Both trials are completed.

Is SD-101 the same as any other drug?

SD-101 is a distinct investigational compound developed by Dynavax Technologies. It is not known to be the same as any other marketed drug. Its unique mechanism as a TLR9 agonist differentiates it from other hepatitis C treatments.