Safety, Pharmacokinetics, and Pharmacodynamics of SD-101 in Healthy Normal Males
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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|
- 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 ]
- 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 ]
|Study Start Date:||January 2008|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
|Experimental: Escalating Dose of SD-101||
Single subcutaneous escalating dose
|Placebo Comparator: Placebo||
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.
|United States, Texas|
|Healthcare Discoveries, Inc.|
|San Antonio, Texas, United States, 78209|
|Principal Investigator:||Dennis Ruff, MD||Healthcare Discoveries, Inc.|