Ischemic StrokePhase 1NCT01757795
Safety, Tolerability and Pharmacokinetics of SP-8203
A Phase 1 study testing SP-8203 in people with Ischemic Stroke, run by Shin Poong Pharmaceutical Co. Ltd. at 1 site in South Korea.
Trial summary
Phase I study in health volunteers to assess the safety, tolerability and pharmacokinetics of escalating single doses and multiple doses of SP-8203 Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- SP-8203
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Dec 2013to 11 Mar 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Phase I study in health volunteers to assess the safety, tolerability and pharmacokinetics of escalating single doses and multiple doses of SP-8203
Read the detailed description
This is a Phase I, single-center, randomized, double-blind, placebo-controlled study of the safety, tolerability, and PK of escalating single doses and multiple doses of SP 8203 in healthy adult male and female subjects.
In the SAD Part, the first cohort of 8 subjects will be randomly assigned to receive a single IV dose of either SP-8203 (n=6) or placebo (n=2). Following medical review of safety, PK, and biomarker data, subsequent cohorts of 8 new subjects will receive higher single doses of SP-8203 (6 subjects) or placebo (2 subjects). Dose escalation will continue until a single MTD of SP-8203 is identified. If a single-dose MTD is not defined within the projected dose range, additional cohorts of 8 subjects may be added to receive higher doses to achieve the objectives of the study. Alternate doses may be administered following medical review of the results of each cohort.
In the MAD Part of the study the first cohort of 8 subjects will receive a single dose of SP 8203 every day and 1 subject will receive a single dose of placebo every day for 7 consecutive days. Doses will be administered at the same time (± 15 minutes) every day. Following medical review of all safety and biomarker data, subsequent cohorts of 7 drug-naive subjects will receive higher single doses of SP-8203 (6 subjects) or placebo (2 subject) every day for 7 consecutive days. Study drug dose-escalation will continue until a multiple-dose MTD regimen of SP-8203 is identified. If a multiple-dose MTD is not defined within this range, additional cohorts of 8 subjects may be added to achieve the objectives of the study. Alternate doses and/or dosing regimens may be administered following medical review of the safety, biomarker, and PK results of the SAD Part, and prior cohorts in the MAD Part of the study.
The MTD will be defined as the highest dose that does not lead to unacceptable toxicity in one or more subjects based on the frequency, nature, and severity of AEs or other safety parameter abnormalities. The Investigator, Sponsor, and Medical Monitor will jointly assess the general safety and tolerability of each dose based on available data prior to escalating to the next higher dose. Successive higher doses will be administered only if previous doses are adequately tolerated. Intermediate doses may be tested, or a dose level may be repeated, as appropriate, depending on the safety profile observed.
Each subject will complete Screening, Baseline, Treatment, and Follow-Up Phases. The Screening Phase will be conducted on an outpatient basis within 30 days, but no sooner than 3 days, prior to the start of the Baseline Phase. The Baseline Phase will consist of admission to the CRU and final qualification assessments.
In the SAD Part, the Treatment Phase will consist of dosing (after which subjects will be considered enrolled in the study), postdose safety assessments, and blood and urine collection for the next 48 hours. Subjects will be discharged approximately 48 hours after study drug administration, provided all available assessments are clinically acceptable to the Investigator, and will return for follow-up assessments 2-4 days later. In the MAD Part, The Treatment Phase will last for 9 days following the first dose. Subjects will be dosed each morning for 7 consecutive days. Safety assessments will be made, and blood and urine will be collected prior to, and at prescribed intervals postdose, over the next 9 consecutive days. Subjects will be discharged approximately 48 hours following the last dose, and will return for follow-up assessments 2-4 days later.
Safety will be evaluated by physical examination, by evaluation of vital signs, 12 lead ECG, Holter monitoring, clinical laboratory blood and urine test results, and AE assessments. Blood samples for determining plasma concentrations of SP 8203 and its metabolites, assessments of Mn-SOD mRNA, and FRAP biomarkers will be obtained immediately prior to dosing and at prescribed intervals during the Treatment Phase. Urine samples will be collected predose and pooled urine samples will be collected postdose for determination of SP 8203 renal clearance and metabolites.
- Conditions
- Ischemic Stroke
- Being tested
- SP-8203, Placebo
- Keywords
- acute ischemic stroke, ischemic stroke, stroke
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP-8203Drug
Also called SP8203HCL
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
PlaceboDrug
Placebo will be intravenously administered
| Study group | Role | What they receive |
|---|---|---|
| SP-8203 | Experimental | Active arm Receives: Drug: SP-8203 |
| Placebo | Placebo comparator | Matching Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: within 9 days of first administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study start23 Dec 2013
- Primary completion11 Mar 2015
- Study completion11 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyun-Seop Bae, MD, Ph.D., Principal investigator, ASAN Medical Center Songpa-gu, Seoul, Korea, Republic of
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757795
- Sponsor's protocol ID
- SP-8203-1001
- Status last verified
- Jul 2020
- First submitted
- 21 Dec 2012
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01757795
- Acronym / sponsor ID
- SP-8203-1001
- Conditions
- Ischemic Stroke
- Keywords
- acute ischemic stroke, ischemic stroke, stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Dec 2013 (actual)
- Primary completion
- 11 Mar 2015 (actual)
- Study completion
- 11 Mar 2015 (actual)
- First posted
- 31 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I study in health volunteers to assess the safety, tolerability and pharmacokinetics of escalating single doses and multiple doses of SP-8203
Detailed description
This is a Phase I, single-center, randomized, double-blind, placebo-controlled study of the safety, tolerability, and PK of escalating single doses and multiple doses of SP 8203 in healthy adult male and female subjects.
In the SAD Part, the first cohort of 8 subjects will be randomly assigned to receive a single IV dose of either SP-8203 (n=6) or placebo (n=2). Following medical review of safety, PK, and biomarker data, subsequent cohorts of 8 new subjects will receive higher single doses of SP-8203 (6 subjects) or placebo (2 subjects). Dose escalation will continue until a single MTD of SP-8203 is identified. If a single-dose MTD is not defined within the projected dose range, additional cohorts of 8 subjects may be added to receive higher doses to achieve the objectives of the study. Alternate doses may be administered following medical review of the results of each cohort.
In the MAD Part of the study the first cohort of 8 subjects will receive a single dose of SP 8203 every day and 1 subject will receive a single dose of placebo every day for 7 consecutive days. Doses will be administered at the same time (± 15 minutes) every day. Following medical review of all safety and biomarker data, subsequent cohorts of 7 drug-naive subjects will receive higher single doses of SP-8203 (6 subjects) or placebo (2 subject) every day for 7 consecutive days. Study drug dose-escalation will continue until a multiple-dose MTD regimen of SP-8203 is identified. If a multiple-dose MTD is not defined within this range, additional cohorts of 8 subjects may be added to achieve the objectives of the study. Alternate doses and/or dosing regimens may be administered following medical review of the safety, biomarker, and PK results of the SAD Part, and prior cohorts in the MAD Part of the study.
The MTD will be defined as the highest dose that does not lead to unacceptable toxicity in one or more subjects based on the frequency, nature, and severity of AEs or other safety parameter abnormalities. The Investigator, Sponsor, and Medical Monitor will jointly assess the general safety and tolerability of each dose based on available data prior to escalating to the next higher dose. Successive higher doses will be administered only if previous doses are adequately tolerated. Intermediate doses may be tested, or a dose level may be repeated, as appropriate, depending on the safety profile observed.
Each subject will complete Screening, Baseline, Treatment, and Follow-Up Phases. The Screening Phase will be conducted on an outpatient basis within 30 days, but no sooner than 3 days, prior to the start of the Baseline Phase. The Baseline Phase will consist of admission to the CRU and final qualification assessments.
In the SAD Part, the Treatment Phase will consist of dosing (after which subjects will be considered enrolled in the study), postdose safety assessments, and blood and urine collection for the next 48 hours. Subjects will be discharged approximately 48 hours after study drug administration, provided all available assessments are clinically acceptable to the Investigator, and will return for follow-up assessments 2-4 days later. In the MAD Part, The Treatment Phase will last for 9 days following the first dose. Subjects will be dosed each morning for 7 consecutive days. Safety assessments will be made, and blood and urine will be collected prior to, and at prescribed intervals postdose, over the next 9 consecutive days. Subjects will be discharged approximately 48 hours following the last dose, and will return for follow-up assessments 2-4 days later.
Safety will be evaluated by physical examination, by evaluation of vital signs, 12 lead ECG, Holter monitoring, clinical laboratory blood and urine test results, and AE assessments. Blood samples for determining plasma concentrations of SP 8203 and its metabolites, assessments of Mn-SOD mRNA, and FRAP biomarkers will be obtained immediately prior to dosing and at prescribed intervals during the Treatment Phase. Urine samples will be collected predose and pooled urine samples will be collected postdose for determination of SP 8203 renal clearance and metabolites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SP-8203 | Experimental | Drug: SP-8203Active arm |
| Placebo | Placebo comparator | Drug: PlaceboMatching Placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SP-8203Also: SP8203HCLSP-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 | Drug | SP-8203 |
| PlaceboPlacebo will be intravenously administered | Drug | Placebo |
Primary outcome
The incidence rate of adverse events, and adverse drug reaction in single ascending doses (SAD)
Time frame: Follow-up to 7 days after administration
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.
The incidence rate of adverse events, and adverse drug reaction in multiple ascending doses (MAD)
Time frame: Follow-up to 13 days after first administration
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 in single ascending doses (SAD)
Time frame: within 3 days of administration
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.
Pharmacokinetics in multiple ascending doses (MAD)
Time frame: within 9 days of first administration
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyun-Seop Bae, MD, Ph.D. principal investigator
ASAN Medical Center Songpa-gu, Seoul, Korea, Republic of
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SP-8203 in people with Ischemic Stroke, run by Shin Poong Pharmaceutical Co. Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate of adverse events, and adverse drug reaction in single ascending doses (SAD) (time frame: Follow-up to 7 days after administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.