Safety, Tolerability and Pharmacokinetics of SP-8203

NCT01757795 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: SP-8203-1001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Ischemic Stroke

Keywords

acute ischemic stroke; ischemic stroke; stroke

Outcome Measures

Primary Outcomes (4)

• The incidence rate of adverse events, and adverse drug reaction in single ascending doses (SAD)

  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.

  Follow-up to 7 days after administration

• The incidence rate of adverse events, and adverse drug reaction in multiple ascending doses (MAD)

  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.

  Follow-up to 13 days after first administration

• Pharmacokinetics in single ascending doses (SAD)

  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.

  within 3 days of administration

• Pharmacokinetics in multiple ascending doses (MAD)

  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.

  within 9 days of first administration

Study Arms (2)

SP-8203

EXPERIMENTAL

Active arm

Drug: SP-8203

Placebo

PLACEBO COMPARATOR

Matching Placebo

Drug: Placebo

Interventions

SP-8203 DRUG

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

Also known as: SP8203HCL

SP-8203

Placebo DRUG

Placebo will be intravenously administered

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female ages of 20 and 45 years, inclusive.
• Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control, or be surgically sterile or post-menopausal.
• Males must be agree to practice an medically acceptable method of birth control and will not donate sperm during the study.
• Subject's body mass index (BMI) is ≥ 18 and ≤ 32, inclusive.
• Subject does not smoke and has not smoked or used nicotine-containing products for at least 6 continuous months prior to the first dose.
• Subject has adequate venous access for repeated venipuncture.
• Subject has hemoglobin \>/= 11.5 g/dL.
• 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.
• Subject agrees to abstain from consuming alcohol-containing beverages for 3 days prior to CRU admission through discharge.
• Subject agrees to abstain from consuming caffeine- or chocolate-containing products from CRU admission through discharge.
• 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.
• 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.
• Subject voluntarily provides written informed consent.

You may not qualify if:

• 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.
• History of anaphylaxis, a documented hypersensitivity reaction, or a clinically important idiosyncratic reaction to any drug.
• Predisposing condition that could interfere with the distribution, metabolism, or excretion of drugs or any condition that may confound the PK analyses.
• Positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C virus.
• Have chronic Qt prolongation syndrome (i.e. Qt \> 450 ms for males and \>470 ms for females) in repeated EKG measurements.
• Drugs or substances known to inhibit or induce cytochrome 2D6 (CYP) enzymes within 28 days prior to the first dose and throughout the study.
• Recent (2-year) history or evidence of alcoholism or drug abuse.
• Positive for alcohol or drugs of abuse at the Screening Visit or upon admission to the CRU.
• Special diet during the 28 days prior to the first dose (eg, Atkins, South Beach, or any other high protein / high fat diets).
• Subject reports difficulty fasting or consuming standardized meals.
• Subject has donated blood or plasma (eg. Plasmapheresis) within 28 days prior to the first dose of study medication.
• Participated in another clinical trial within 90 days prior to dosing.
• 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.
• Investigator's decision to exclude for other reason.

Sponsors & Collaborators

• Shin Poong Pharmaceutical Co. Ltd.: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

otaplimastat

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kyun-Seop Bae, MD, Ph.D.

  ASAN Medical Center Songpa-gu, Seoul, Korea, Republic of

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2012
• First Posted: December 31, 2012
• Study Start: December 23, 2013
• Primary Completion: March 11, 2015
• Study Completion: March 11, 2015
• Last Updated: July 22, 2020

Record last verified: 2020-07

Locations

KR (1)