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Status unknownNCT03358901Updated Dec 6, 2017

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

A Phase 1 interventional study of YC-6 and Vehicle in Ischemic Stroke, sponsored by Guangzhou Cellprotek Pharmaceutical Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-06.

Sponsored by Guangzhou Cellprotek Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Ischemic Stroke

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03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 18\~55 years old healthy subjects
  2. BW ≥ 50 kg, BMI 18\~28 kg/m²
  3. Signed the informed consent from to participate voluntarily and to comply with the trial requirements

Exclusion criteria

Exclusion Criteria:

  1. History of clinically significant cardiovascular, hepatic, renal, gastrointestinal, hematologic diseases
  2. Clinically significant abnormality evidenced from detailed physical examination, 12-lead ECG, biochemistry, hematology, and routine urine analysis
  3. Glomerular filtration rate (GFR) \< 80 mL/min
  4. Any medication within 2 weeks before the first administration in this study
  5. History of clinically significant allergy and hypersensitivity
  6. Hepatitis B or C, syphilis, or HIV infection on serological examination
  7. History of alcoholic addiction or drug abuse within a year before this study
  8. Failing of smoking and drunk cessation (Breath carbon monoxide test > 7 ppm) during this study
  9. Participated in any drug trial within 3 months before this study
  10. Donated blood or blood product ≥ 400 mL or 2 units within 3 months before this study
  11. Dissented to avoid intake of tobacco, alcohol, or caffeine, and strenuous exercise or any behavior that would affect the ADME of YC-6
  12. Pregnant or breast-feeding women
  13. Other subject conditions unsuitable for enrollment in this study
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    YC-6

    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

  • Placebo comparator
    Vehicle

    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

  • DrugYC-6
  • DrugVehicle
05

What researchers measure

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.

    Time frame: 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.

    Time frame: Day 0 to Day 8

06

Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, China
    • Yan Sun, BM · Contact · cprc@pumch.cn · 86（10）69158355
    • Bei Hu, MD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03358901
Lead sponsor
Guangzhou Cellprotek Pharmaceutical Co., Ltd.
Collaborators
Xiuhe Medical Technique Co.,Ltd.
Responsible party
Sponsor
First posted
Dec 2, 2017
Start date
Dec 2016
Primary completion
Dec 2017 (estimated)
Completion
Jan 2018 (estimated)
Last update
Dec 6, 2017

Study contacts

Yan Sun, BM
Contact
cprc@pumch.cn
86（10）69158355 ext. 11
Bei Hu, MD
principal investigator · Peking Union Medical College Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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