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

Primary Purpose

Ischemic Stroke

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

YC-6

Vehicle

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

YC-6

Vehicle

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Plasma Concentration of YC-6

Concentration of YC-6 in plasma of every subject will be measured during day 0 to day 8.

Full Information

NCT ID

NCT03358901

First Posted

December 16, 2016

Last Updated

December 4, 2017

Sponsor

Guangzhou Cellprotek Pharmaceutical Co., Ltd.

Collaborators

Xiuhe Medical Technique Co.,Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03358901

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Guangzhou Cellprotek Pharmaceutical Co., Ltd.

Collaborators

Xiuhe Medical Technique Co.,Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

YC-6

Arm Type

Experimental

Arm Description

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.

Arm Title

Vehicle

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

YC-6

Intervention Type

Drug

Intervention Name(s)

Vehicle

Primary Outcome Measure Information:

Title

Number of participants who experience treatment-related adverse events (AEs) and serious adverse events (SAEs)

Description

Any untoward medical events during this study were categorized as severe, moderate, or mild, and related or not related to study treatment.

Time Frame

Day 0 to Day 11

Secondary Outcome Measure Information:

Title

Plasma Concentration of YC-6

Description

Concentration of YC-6 in plasma of every subject will be measured during day 0 to day 8.

Time Frame

Day 0 to Day 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yan Sun, BM

Phone

86（10）69158355

Ext

cprc@pumch.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bei Hu, MD

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yan Sun, BM

Phone

86（10）69158355

Ext

cprc@pumch.cn

First Name & Middle Initial & Last Name & Degree

Bei Hu, MD

12. IPD Sharing Statement

Plan to Share IPD

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

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