Safety and Pharmacokinetics of Multiple Dose of YC-6 in H... | NCT03358901

Studies
Safety and Pharmacokinetics of Multiple Dose of YC-6 in Healthy Subjects

NCT03358901

Sponsor

Guangzhou Cellprotek Pharmaceutical Co., Ltd.

Status

Unknown status

Last Update Posted

Dec 6, 2017Actual

Enrollment

32Estimated

Phase

Phase 1

Conditions

Ischemic Stroke

Interventions

YC-6
Vehicle

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Dec 2017Estimated

Completion Date

Jan 2018Estimated

First Submitted Date

Dec 16, 2016

First Submission Date that Met QC Criteria

Nov 26, 2017

First Posted Date

Dec 2, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2017

Last Update Posted Date

Dec 6, 2017Actual

Name	Class
Xiuhe Medical Technique Co.,Ltd.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.	Drug: Vehicle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
YC-6	Drug		YC-6
Vehicle

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Day 0 to Day 11

Secondary Outcomes

Measure	Description	Time Frame
Plasma Concentration of YC-6	Concentration of YC-6 in plasma of every subject will be measured during day 0 to day 8.	Day 0 to Day 8

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Yan Sun, BM	Contact	86（10）69158355	11	cprc@pumch.cn

Name	Affiliation	Role
Bei Hu, MD	Peking Union Medical College Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital	Recruiting	Beijing			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases