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

NCT03358901 | Unknown Phase 1 DMC

• 1 other identifier: YC-6-PI-M
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Plasma Concentration of YC-6

  Day 0 to Day 8

Study Arms (2)

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

YC-6 DRUG

YC-6

Vehicle DRUG

Vehicle

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \~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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou Cellprotek Pharmaceutical Co., Ltd.: lead
• Xiuhe Medical Technique Co.,Ltd.: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Bei Hu, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Sun, BM

CONTACT

86（10）69158355; cprc@pumch.cn

Study Design

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

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 2, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: December 6, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)