NCT00599001

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Dynavax Technologies Corporation · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	SD-101	Single subcutaneous escalating dose
DRUG	placebo	placebo

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2008-01-23
• Last updated: 2019-04-16

Locations

1 site across 1 country: United States