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Safety, Tolerability and Pharmacokinetics of SP-8203

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by Shin Poong Pharmaceutical Co. Ltd.
Sponsor:
Information provided by (Responsible Party):
Shin Poong Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier:
NCT01757795
First received: December 21, 2012
Last updated: December 28, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Ischemic Stroke
Drug: SP-8203
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Shin Poong Pharmaceutical Co. Ltd.:

Primary Outcome Measures:
  • Efficacy [ Time Frame: SAD - Days 1-5; MAD - Days 1-9 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: March 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757795

Locations
Korea, Republic of
ASAN Medical Center Not yet recruiting
Songpa-gu, Seoul, Korea, Republic of
Contact: Kyun-Seop Bae, M.D., Ph.D    011-82-2-3010-4611    ksbae@amc.seoul.kr   
Principal Investigator: Kyun-Seop Bae, MD, Ph.D         
Sponsors and Collaborators
Shin Poong Pharmaceutical Co. Ltd.
Investigators
Principal Investigator: Kyun-Seop Bae, MD, Ph.D. ASAN Medical Center Songpa-gu, Seoul, Korea, Republic of
  More Information

No publications provided

Responsible Party: Shin Poong Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT01757795     History of Changes
Other Study ID Numbers: SP-8203-1001
Study First Received: December 21, 2012
Last Updated: December 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Shin Poong Pharmaceutical Co. Ltd.:
acute ischemic stroke
ischemic stroke
stroke

ClinicalTrials.gov processed this record on November 20, 2014