Safety, Tolerability and Pharmacokinetics of SP-8203
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|ClinicalTrials.gov Identifier: NCT01757795|
Recruitment Status : Unknown
Verified December 2012 by Shin Poong Pharmaceutical Co. Ltd..
Recruitment status was: Not yet recruiting
First Posted : December 31, 2012
Last Update Posted : December 31, 2012
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke||Drug: SP-8203 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase I Single-Center, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses and Multiple Doses of SP-8203|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||July 2014|
SP-8203 injection at single ascending doses of 10 mg, 20 mg, 40 mg, 80 mg, 160 mg and 240 mg (optional) SP-8203 injection at multiple ascending doses for 7 days at least 2 dose levels below the MTD in the single ascending portion of the trial
Other Name: SP8203HCL
Placebo Comparator: Placebo
- Efficacy [ Time Frame: SAD - Days 1-5; MAD - Days 1-9 ]The efficacy of SP-8203 is not being evaluated in this study. The biomarkers Manganese-superoxide dismutase mRNA (Mn-SOD mRNA) and ferric-reducing ability of plasma (FRAP) will be assayed for signals of potential efficacy.
- Safety [ Time Frame: SAD - Days 1-5 and Mad - Days 1-9 ]The safety of SP-8203 will be evaluated by monitoring treatment-emergent adverse events (AE), changes in 12 lead electrocardiograms (ECG), clinical laboratory tests, vital signs, and physical examinations, as well as clinically important changes in heart rate.
- Pharmacokinetics [ Time Frame: SAD - Days 1-5 and MAD - Days 1-9 ]Plasma concentrations of SP-8203 will be measured by a validated liquid chromatography-tandem mass spectrometry assay procedure and PK parameters will be determined. Urine will be collected predose and at specified intervals postdose for the determination of SP-8203 renal clearance.
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): NCT01757795
|Korea, Republic of|
|ASAN Medical Center|
|Songpa-gu, Seoul, Korea, Republic of|
|Contact: Kyun-Seop Bae, M.D., Ph.D 011-82-2-3010-4611 firstname.lastname@example.org|
|Principal Investigator: Kyun-Seop Bae, MD, Ph.D|
|Principal Investigator:||Kyun-Seop Bae, MD, Ph.D.||ASAN Medical Center Songpa-gu, Seoul, Korea, Republic of|