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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00599001
Recruitment Status : Completed
First Posted : January 23, 2008
Last Update Posted : March 1, 2018
Information provided by (Responsible Party):
Dynavax Technologies Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: SD-101 Drug: placebo Phase 1

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Single-Blind, Placebo-Controlled Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of SD-101 in Healthy Normal Male Volunteers
Study Start Date : January 2008
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Arm Intervention/treatment
Experimental: Escalating Dose of SD-101 Drug: SD-101
Single subcutaneous escalating dose

Placebo Comparator: Placebo Drug: placebo

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters [ Time Frame: Up to 24 hours after dosing ]
  2. Levels of serum cytokines [ Time Frame: Up to 7 days after dosing ]
  3. Levels of blood biomarkers (interferon-alpha inducible genes) [ Time Frame: Up to 7 days after dosing ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00599001

United States, Texas
Healthcare Discoveries, Inc.
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Dynavax Technologies Corporation
Principal Investigator: Dennis Ruff, MD Healthcare Discoveries, Inc.

Additional Information:
Responsible Party: Dynavax Technologies Corporation Identifier: NCT00599001     History of Changes
Other Study ID Numbers: DV3-HNV-01
First Posted: January 23, 2008    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: No Change to status of this study.

Keywords provided by Dynavax Technologies Corporation:
healthy volunteer
research subjects
Immunostimulatory sequence (ISS)
phase 1