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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03358901

Enrollment

Registered

2017-12-02

Start date

2016-12-31

Completion date

2018-01-31

Last updated

2017-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

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.

Interventions

DRUGYC-6

DRUGVehicle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants who experience treatment-related adverse events (AEs) and serious adverse events (SAEs)	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.

Secondary

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

Countries

China

Contacts

Primary ContactYan Sun, BM

cprc@pumch.cn86（10）69158355

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026