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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00599001

Run by

Dynavax Technologies Corporation

People needed

26

Starts

2008-01-01

Expected to finish

2008-03-01

Last updated by the study team

2019-04-16

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Healthcare Discoveries, Inc. — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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