Traumatic brain injury(Healthy Volunteers)
Conditions
Interventions
Single Dose-Group 1 :GRK-006 for injection/placebo 7.5 mg
Single Dose-Group 2 :GRK-006 for injection/placebo 15 mg
Single Dose-Group 3 :GRK-006 for injection/placebo 30 mg
Single Dose-Group 4:GRK-006 for injection/placebo 50 mg
Single Dose-Group 5:GRK-006 for injection/placebo 75 mg
Single Dose-Group 6:GRK-006 for injection/placebo 100 mg
Multiple Dose-Group 1:GRK-006 for injection/placebo 15 mg qid
Multiple Dose-Group 2:GRK-006 for injection/placebo 30 mg qid
Multiple Dose-Group 3:GRK-006 for injection/placebo 50 mg qid
Multiple Dose-Group 4:GRK-006 for injection/placebo 75 mg qid
Sponsors
First Hospital Affiliated to suzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Having given written informed consent prior to undertaking any study-related procedure; 2. Male and/or female, between 18 and 55 years of age, inclusive;Not less than 1/3 of the female participants in each dose group; 3.Female subjects must be: Menopausal, or medically certified for infertility surgery, or If fertility is present, the subject must agree to use at least 1 highly effective method of contraception and 1 additional effective method of contraception at the same time. Contraception is available from at least 1 month prior to study entry to 3 months after the last dose, avoiding egg donation or in vitro fertilization during the trial and for 90 days after the last dose, or if the subject agrees to complete abstinence. Male subjects must agree (even after infertility surgery such as vasectomy, etc.) to use effective barrier contraception (spermicidal condoms or other) and to avoid sperm donation for the duration of the study and for 90 days after the last dose, or if the subject agrees to complete abstinence; 4.Body weight at least 50kg, inclusive, if male, and 45kg or more, inclusive, if female, body mass index between 19.0 and 26.0 kg/m2, inclusive.
Exclusion criteria
Exclusion criteria: 1.Any history or presence of clinically relevant serious cardiovascular, hepatic, endocrine, gastrointestinal, metabolic, neurological, pulmonary, endocrine, psychiatric, or neoplastic disease that is assessed by the investigator to be unsuitable for participation in this study 2.A clinically significant disease, condition, or other evidence that, in the opinion of the investigator, poses a risk to subject safety or interferes with the conduct, execution, or completion of the study; 3.Positive test for Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) Antibody, Syphilis Spirochete Antibody or Human Immunodeficiency Virus (HIV) Antibody; 4.History of febrile illness or evidence of active infection within 7 days prior to the first dose of study drug; 5.Pregnant or breastfeeding females or females planning a pregnancy within 1 month prior to the start of the trial up to and including the trial period or 3 months post-trial; 6.Participant has undergone surgery within 3 months prior to screening that, in the judgment of the investigator, would interfere with drug absorption, distribution, metabolism, or excretion or who plans to undergo surgery during the trial period; 7.Participant has received any live vaccine within 28 days prior to screening, or who plans to be vaccinated during the trial period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events;PK parameters for a single dose include, but are not limited to, Tmax, Cmax, AUC0-t, AUC0-8, t1/2, MRT, CL, Vz, etc.;PK parameters for multiple dosing included, but were not limited to, Tmax,ss, Cmin,ss, Cmax,ss, AUC0-tau, AUC0-8,ss, Vss, t1/2,ss, MRT, and CLss;;QTc analysis: change in QTcF, HR, PR interval, RR interval, and QRS duration relative to baseline;; | — |
Secondary
| Measure | Time frame |
|---|---|
| Metabolite profile of GRK-006 in human plasma.; | — |
Countries
China
Contacts
Public ContactMiao Liyan
First Hospital Affiliated to suzhou University
Outcome results
None listed