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

Sponsor

Dynavax Technologies Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00599001

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

13.2

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Jan 1, 2008

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Escalating Dose of SD-101	Drug: SD-101 Single subcutaneous escalating dose
Placebo Comparator: Placebo	Drug: placebo placebo

Arm

Intervention/Treatment

Experimental: Escalating Dose of SD-101

Drug: SD-101

Single subcutaneous escalating dose

Placebo Comparator: Placebo

Drug: placebo

placebo

Outcome Measures

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 [Up to 7 days after dosing]

Secondary Outcome Measures

Pharmacokinetic parameters [Up to 24 hours after dosing]
Levels of serum cytokines [Up to 7 days after dosing]
Levels of blood biomarkers (interferon-alpha inducible genes) [Up to 7 days after dosing]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Healthcare Discoveries, Inc.	San Antonio	Texas	United States	78209

Sponsors and Collaborators

Dynavax Technologies Corporation

Investigators

Principal Investigator: Dennis Ruff, MD, Healthcare Discoveries, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Sponsor Website

Publications

None provided.

Responsible Party:

Dynavax Technologies Corporation

ClinicalTrials.gov Identifier:

NCT00599001

Other Study ID Numbers:

DV3-HNV-01

First Posted:

Jan 23, 2008

Last Update Posted:

Apr 16, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Dynavax Technologies Corporation

healthy volunteer

research subjects

Immunostimulatory sequence (ISS)

phase 1

Study Results

No Results Posted as of Apr 16, 2019