Safety, Pharmacokinetics, and Pharmacodynamics of SD-101 in Healthy Normal Males
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|ClinicalTrials.gov Identifier: NCT00599001|
Recruitment Status : Completed
First Posted : January 23, 2008
Last Update Posted : March 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: SD-101 Drug: placebo||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|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 :||January 2008|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
|Experimental: Escalating Dose of SD-101||
Single subcutaneous escalating dose
|Placebo Comparator: Placebo||
- 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 ]
- Pharmacokinetic parameters [ Time Frame: Up to 24 hours after dosing ]
- Levels of serum cytokines [ Time Frame: Up to 7 days after dosing ]
- Levels of blood biomarkers (interferon-alpha inducible genes) [ Time Frame: Up to 7 days after dosing ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00599001
|United States, Texas|
|Healthcare Discoveries, Inc.|
|San Antonio, Texas, United States, 78209|
|Principal Investigator:||Dennis Ruff, MD||Healthcare Discoveries, Inc.|