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

Sponsored by:	Dynavax Technologies Corporation
Information provided by:	Dynavax Technologies Corporation
ClinicalTrials.gov Identifier:	NCT00599001

Purpose

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	Intervention	Phase
Healthy	Drug: SD-101 Drug: placebo	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety Study
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

Further study details as provided by Dynavax Technologies Corporation:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetic parameters [ Time Frame: Up to 24 hours after dosing ] [ Designated as safety issue: No ]
Levels of serum cytokines [ Time Frame: Up to 7 days after dosing ] [ Designated as safety issue: No ]
Levels of blood biomarkers (interferon-alpha inducible genes) [ Time Frame: Up to 7 days after dosing ] [ Designated as safety issue: No ]

Enrollment:	26
Study Start Date:	January 2008
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Escalating Dose of SD-101: Experimental	Drug: SD-101 Single subcutaneous escalating dose
Placebo: Placebo Comparator	Drug: placebo placebo

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599001

Locations

United States, Texas
Healthcare Discoveries, Inc.
San Antonio, Texas, United States, 78209

Sponsors and Collaborators

Dynavax Technologies Corporation

Investigators

Principal Investigator:

Dennis Ruff, MD

Healthcare Discoveries, Inc.

More Information

Sponsor Website This link exits the ClinicalTrials.gov site

Responsible Party:	Dynavax Technologies Corporation ( Eduardo Martins, MD, DPhil / Vice President, Clinical Development )
Study ID Numbers:	DV3-HNV-01
Study First Received:	January 11, 2008
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00599001
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dynavax Technologies Corporation:

healthy volunteer
research subjects
ISS
phase 1

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 14, 2009