Ischemic StrokePhase 1NCT03358901
Safety and Pharmacokinetics of Multiple Dose of YC-6 in Healthy Subjects
A Phase 1 study testing YC-6 in people with Ischemic Stroke, run by Guangzhou Cellprotek Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study is designed to determine the safety, tolerability, and pharmacokinetics in healthy subjects with multiple intravenous administration of the neuroprotectant YC-6 compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- YC-6
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Jan 2018
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18~55 years old healthy subjects
- BW ≥ 50 kg, BMI 18~28 kg/m²
- Signed the informed consent from to participate voluntarily and to comply with the trial requirements
Who cannot join
- History of clinically significant cardiovascular, hepatic, renal, gastrointestinal, hematologic diseases
- Clinically significant abnormality evidenced from detailed physical examination, 12-lead ECG, biochemistry, hematology, and routine urine analysis
- Glomerular filtration rate (GFR) < 80 mL/min
- Any medication within 2 weeks before the first administration in this study
- History of clinically significant allergy and hypersensitivity
- Hepatitis B or C, syphilis, or HIV infection on serological examination
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- History of alcoholic addiction or drug abuse within a year before this study
- Failing of smoking and drunk cessation (Breath carbon monoxide test > 7 ppm) during this study
- Participated in any drug trial within 3 months before this study
- Donated blood or blood product ≥ 400 mL or 2 units within 3 months before this study
- Dissented to avoid intake of tobacco, alcohol, or caffeine, and strenuous exercise or any behavior that would affect the ADME of YC-6
- Pregnant or breast-feeding women
- Other subject conditions unsuitable for enrollment in this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Yan Sun, BM, 86（10）69158355 ext. 11, cprc@pumch.cn
Bei Hu, MD
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Multiple Intravenous Administration of YC-6 in Healthy Chinese Adult Subjects
The study is designed to determine the safety, tolerability, and pharmacokinetics in healthy subjects with multiple intravenous administration of the neuroprotectant YC-6 compared to placebo.
Read the detailed description
tPA administration within 3-4.5 hours after stroke onset has been the only approved therapy and thus no more than 7% of acute ischemic stroke (AIS) victims worldwide benefited from tPA. A neuroprotectant, YC-6, showed therapeutic effects in preclinical animal models of AIS, indicating its potential as alternative or combined treatment against human AIS.
This randomized, double-blind, placebo-controlled clinical trial is to explore safety and tolerability in healthy Chinese adult volunteers with dose-escalating intravenous infusion of YC-6 for 7 consecutive days. 6 subjects for YC-6 and 2 for placebo will be allocated in each level. Blood and urine samples of each subject will be used in determination of pharmacokinetic properties of the investigational drug.
- Conditions
- Ischemic Stroke
- Being tested
- YC-6, Vehicle
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YC-6Drug
VehicleDrug
| Study group | Role | What they receive |
|---|---|---|
| YC-6 | Experimental | 6 volunteers in each level will be infused 100, 200, 400, or 600 mg of YC-6 over 7 consecutive days: BID within 30 minutes for the first 6 days and QD on the 7th day. Receives: Drug: YC-6 |
| Vehicle | Placebo comparator | 2 volunteers in each level will be infused 2, 4, 8, or 12 g of vehicle over 7 consecutive days: BID within 30 minutes for the first 6 days and QD on the 7th day. Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who experience treatment-related adverse events (AEs) and serious adverse events (SAEs)
Any untoward medical events during this study were categorized as severe, moderate, or mild, and related or not related to study treatment.
Measured: Day 0 to Day 11
Secondary outcomes (1)
Plasma Concentration of YC-6
Concentration of YC-6 in plasma of every subject will be measured during day 0 to day 8.
Measured: Day 0 to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completionJan 2018 (estimated)
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Cellprotek Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xiuhe Medical Technique Co.,Ltd.
- Responsible party
- Sponsor
- Investigators
- Bei Hu, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358901
- Sponsor's protocol ID
- YC-6-PI-M
- Status last verified
- Dec 2017
- First submitted
- 16 Dec 2016
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Multiple Intravenous Administration of YC-6 in Healthy Chinese Adult Subjects
- ClinicalTrials.gov ID
- NCT03358901
- Acronym / sponsor ID
- YC-6-PI-M
- Conditions
- Ischemic Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Guangzhou Cellprotek Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Xiuhe Medical Technique Co.,Ltd.
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 2 Dec 2017 (actual)
- 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.
The study is designed to determine the safety, tolerability, and pharmacokinetics in healthy subjects with multiple intravenous administration of the neuroprotectant YC-6 compared to placebo.
Detailed description
tPA administration within 3-4.5 hours after stroke onset has been the only approved therapy and thus no more than 7% of acute ischemic stroke (AIS) victims worldwide benefited from tPA. A neuroprotectant, YC-6, showed therapeutic effects in preclinical animal models of AIS, indicating its potential as alternative or combined treatment against human AIS.
This randomized, double-blind, placebo-controlled clinical trial is to explore safety and tolerability in healthy Chinese adult volunteers with dose-escalating intravenous infusion of YC-6 for 7 consecutive days. 6 subjects for YC-6 and 2 for placebo will be allocated in each level. Blood and urine samples of each subject will be used in determination of pharmacokinetic properties of the investigational drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YC-6 | Experimental | Drug: YC-66 volunteers in each level will be infused 100, 200, 400, or 600 mg of YC-6 over 7 consecutive days: BID within 30 minutes for the first 6 days and QD on the 7th day. |
| Vehicle | Placebo comparator | Drug: Vehicle2 volunteers in each level will be infused 2, 4, 8, or 12 g of vehicle over 7 consecutive days: BID within 30 minutes for the first 6 days and QD on the 7th day. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18~55 years old healthy subjects
- BW ≥ 50 kg, BMI 18~28 kg/m²
- Signed the informed consent from to participate voluntarily and to comply with the trial requirements
Key exclusion criteria (13 listed)
- History of clinically significant cardiovascular, hepatic, renal, gastrointestinal, hematologic diseases
- Clinically significant abnormality evidenced from detailed physical examination, 12-lead ECG, biochemistry, hematology, and routine urine analysis
- Glomerular filtration rate (GFR) < 80 mL/min
- Any medication within 2 weeks before the first administration in this study
- History of clinically significant allergy and hypersensitivity
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 |
|---|---|---|
| YC-6 | Drug | YC-6 |
| Vehicle | Drug | Vehicle |
Primary outcome
Number of participants who experience treatment-related adverse events (AEs) and serious adverse events (SAEs)
Time frame: Day 0 to Day 11
Any untoward medical events during this study were categorized as severe, moderate, or mild, and related or not related to study treatment.
1 secondary outcome
Plasma Concentration of YC-6
Time frame: Day 0 to Day 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Bei Hu, MD principal investigator
Peking Union Medical College Hospital
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 YC-6 in people with Ischemic Stroke, run by Guangzhou Cellprotek Pharmaceutical Co., Ltd. at 1 site in China.
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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 6 Dec 2017. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Sun, BM (86（10）69158355 ext. 11, cprc@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who experience treatment-related adverse events (AEs) and serious adverse events (SAEs) (time frame: Day 0 to Day 11). 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 6 Dec 2017.