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Safety, Pharmacokinetics, and Pharmacodynamics of SD-101 in Healthy Normal Males

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ClinicalTrials.gov Identifier: NCT00599001
Recruitment Status : Completed
First Posted : January 23, 2008
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Dynavax Technologies Corporation

January 11, 2008
January 23, 2008
March 1, 2018
January 2008
March 2008   (Final data collection date for primary outcome measure)
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 [ Time Frame: Up to 7 days after dosing ]
Same as current
Complete list of historical versions of study NCT00599001 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic parameters [ Time Frame: Up to 24 hours after dosing ]
  • Levels of serum cytokines [ Time Frame: Up to 7 days after dosing ]
  • Levels of blood biomarkers (interferon-alpha inducible genes) [ Time Frame: Up to 7 days after dosing ]
Same as current
Not Provided
Not Provided
 
Safety, Pharmacokinetics, and Pharmacodynamics of SD-101 in Healthy Normal Males
A Phase 1, Randomized, Single-Blind, Placebo-Controlled Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of SD-101 in Healthy Normal Male Volunteers
The main purpose of this study is to assess the safety, tolerability, and biological activity of SD-101 compared with placebo in healthy male volunteers.

This is a Phase 1, randomized, single-blind, placebo-controlled study of five escalating dose levels of SD-101 in healthy male volunteers. The objectives of the study are to assess the safety, tolerability, pharmacokinetic profile, and pharmacodynamics of SD-101. Approximately 40 subjects will participate.

Once subjects have been consented, screened, and assigned to one of the dose levels of SD-101, subjects will receive a single subcutaneous injection of either SD-101 or placebo (PBS) in a ratio of 6:2.

Safety and tolerability will be evaluated by occurrence of adverse events, blood and urine laboratory tests, physical examination findings, vital signs , and electrocardiogram findings. Pharmacodynamics will be evaluated by levels of blood biomarkers and serum cytokines, and flow cytometric cell counts. Pharmacokinetics will be evaluated by levels of study drug in serum.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Healthy
  • Drug: SD-101
    Single subcutaneous escalating dose
  • Drug: placebo
    placebo
  • Experimental: Escalating Dose of SD-101
    Intervention: Drug: SD-101
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
40
March 2008
March 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed, written, informed consent must be obtained from the subjects before any study-specific procedures are performed.
  • Subject must be male and 18 years of age or older.
  • Subject must be willing to submit to a urine drug screen and agree to abstain from alcohol, caffeine, and tobacco during the required stay in the Phase I Unit.
  • Subject must be willing to abide by the rules of the Phase 1 Unit.
  • Subjects whose sexual partners are of childbearing potential must agree to use an effective method of birth control (i.e., chemical contraceptives, barrier plus spermicide, intrauterine device) during the treatment phase and for 14 days post treatment.
  • Must be negative for Hepatitis B and C and human immunodeficiency virus (HIV).

Exclusion Criteria:

  • Females.
  • Clinically significant active, acute, or chronic illness.
  • History of coagulation or bleeding disorders.
  • Clinically significant chronic or recent (within 21 days of dosing) acute gastrointestinal disorder with nausea, vomiting or diarrhea as a major symptom.
  • Received any vaccine within 3 weeks of study entry or plans to be vaccinated within 6 weeks after study injection.
  • History of significant cardiovascular or cerebrovascular disease.
  • History of evaluation for autoimmune disease including systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), scleroderma or thyroiditis.
  • Significant psychiatric illness that could potentially interfere with the assessments during this study.
  • Subjects who have had prior surgery or a major infection within 6 months of dosing.
  • History of medications within 7 days of dosing, except vitamins and/or minerals.
  • History of Gilbert's disease.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00599001
DV3-HNV-01
No
Not Provided
Plan to Share IPD: Undecided
Plan Description: No Change to status of this study.
Dynavax Technologies Corporation
Dynavax Technologies Corporation
Not Provided
Principal Investigator: Dennis Ruff, MD Healthcare Discoveries, Inc.
Dynavax Technologies Corporation
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP