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Safety, Tolerability and Pharmacokinetics of SP-8203

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Shin Poong Pharmaceutical Co. Ltd.

Brief Summary:
Phase I study in health volunteers to assess the safety, tolerability and pharmacokinetics of escalating single doses and multiple doses of SP-8203

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: SP-8203 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: SP-8203
Active arm
Drug: SP-8203
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
Matching Placebo
Drug: Placebo

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Male or female ages of 20 and 45 years, inclusive.
  2. Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control, or be surgically sterile or post-menopausal.
  3. Males must be agree to practice an medically acceptable method of birth control and will not donate sperm during the study.
  4. Subject's body mass index (BMI) is ≥ 18 and ≤ 32, inclusive.
  5. Subject does not smoke and has not smoked or used nicotine-containing products for at least 6 continuous months prior to the first dose.
  6. Subject has adequate venous access for repeated venipuncture.
  7. Subject has hemoglobin >/= 11.5 g/dL.
  8. Subject agrees to abstain from taking any dietary supplements or non-prescription drugs (except for multivitamins or as otherwise authorized by the Investigator and Medical Monitor) for 14 days prior to CRU admission through discharge.
  9. Subject agrees to abstain from consuming alcohol-containing beverages for 3 days prior to CRU admission through discharge.
  10. Subject agrees to abstain from consuming caffeine- or chocolate-containing products from CRU admission through discharge.
  11. Subject is in general good health based on medical history and clinically acceptable results on the following assessments: physical examination, vital signs, 12 lead ECG, clinical chemistry, hematology/coagulation, and urinalysis.
  12. Seated systolic blood pressure must be >90 mmHg and >140 mmHg and seated diastolic blood pressure must be >50 mmHg and >90 mmHg at Screening and Baseline.
  13. Subject voluntarily provides written informed consent.

Exclusion Criteria:

  1. Subject has a history or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
  2. History of anaphylaxis, a documented hypersensitivity reaction, or a clinically important idiosyncratic reaction to any drug.
  3. Predisposing condition that could interfere with the distribution, metabolism, or excretion of drugs or any condition that may confound the PK analyses.
  4. Positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C virus.
  5. Have chronic Qt prolongation syndrome (i.e. Qt > 450 ms for males and >470 ms for females) in repeated EKG measurements.
  6. Drugs or substances known to inhibit or induce cytochrome 2D6 (CYP) enzymes within 28 days prior to the first dose and throughout the study.
  7. Recent (2-year) history or evidence of alcoholism or drug abuse.
  8. Positive for alcohol or drugs of abuse at the Screening Visit or upon admission to the CRU.
  9. Special diet during the 28 days prior to the first dose (eg, Atkins, South Beach, or any other high protein / high fat diets).
  10. Subject reports difficulty fasting or consuming standardized meals.
  11. Subject has donated blood or plasma (eg. Plasmapheresis) within 28 days prior to the first dose of study medication.
  12. Participated in another clinical trial within 90 days prior to dosing.
  13. History of malignancy within the past 5 years, with the exception of successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin and/or localized carcinoma in situ of the cervix.
  14. Investigator's decision to exclude for other reason.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01757795

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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   
Principal Investigator: Kyun-Seop Bae, MD, Ph.D         
Sponsors and Collaborators
Shin Poong Pharmaceutical Co. Ltd.
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Principal Investigator: Kyun-Seop Bae, MD, Ph.D. ASAN Medical Center Songpa-gu, Seoul, Korea, Republic of
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Responsible Party: Shin Poong Pharmaceutical Co. Ltd. Identifier: NCT01757795    
Other Study ID Numbers: SP-8203-1001
First Posted: December 31, 2012    Key Record Dates
Last Update Posted: December 31, 2012
Last Verified: December 2012
Keywords provided by Shin Poong Pharmaceutical Co. Ltd.:
acute ischemic stroke
ischemic stroke
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes