Sepsis
Conditions
Interventions
Single dose increasing group:Single intravenous administration of GPN00068.
Low doses: 0.01 mg/kg, 0.04 mg/kg
Administration: GPN00068 injection administered by intravenous bolus injection (within
Multiple dose escalation group:Multiple intravenous administrations of GPN00068.
Administration: GPN00068 injection administered via intravenous infusion over 30 minutes, dosed every 12 hours (+/-0.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Subjects understand and comply with the study procedures, voluntarily participate, and have signed the informed consent form; 2. Healthy adult subjects aged 18 to 45 years (inclusive), of either sex; 3. Body weight not exceeding 80 kg. Male subjects must weigh at least 50 kg, and female subjects at least 45 kg. BMI = body weight (kg) / height^2 (kg/m^2), with a body mass index within the range of 18 to 26 kg/m^2 (inclusive); 4. Non-alcoholic; agree to abstain from smoking and alcohol consumption during the study period; 5. Subjects with no intention to conceive from screening through 6 months after the last dose, and who agree to use effective contraceptive measures during the study; women of childbearing potential must have a negative serum pregnancy test.
Exclusion criteria
Exclusion criteria: 1. Subjects with clinically significant diseases prior to screening (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardiovascular diseases); 2. Subjects with a family history of long QT syndrome (in grandparents, parents, or siblings) or prolonged QT interval during screening (male >= 0.45 sec, female >= 0.47 sec); 3. Subjects with a history of gastrointestinal, hepatic, or renal diseases or surgeries prior to screening that may potentially affect the absorption, distribution, metabolism, or excretion of the investigational product, or any condition that may pose a risk to the subject; 4. Any clinically significant findings from physical examination, electrocardiogram (ECG), or clinical laboratory tests; 5. Abnormal vital signs (systolic blood pressure = 140 mmHg, diastolic blood pressure >= 90 mmHg or = 100 bpm); 6. Urinary tract obstruction or difficulty with urinary emptying during screening; 7. Subjects with a history of alcohol abuse (defined as consumption of 14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine), or consumption of any alcoholic product within 48 hours prior to first dosing, or a positive breath alcohol test during screening; 8. Subjects with a history of drug abuse or use of illicit drugs within the past 2 years, or a positive urine drug screen during screening; 9. Subjects who smoked more than 5 cigarettes per day within the past 3 months, or who are unable to abstain from smoking from the time of signing the informed consent until study completion; 10. Subjects with positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and/or human immunodeficiency virus (HIV) antibody, or syphilis serology (TRUST); 11. Subjects who used any prescription medication within 4 weeks prior to enrollment, or any over-the-counter medication (including vitamins, herbal supplements, etc.) within 2 weeks prior to enrollment, or consumed foods affecting drug-metabolizing enzymes (e.g., grapefruit or grapefruit-containing beverages) within 2 weeks prior to enrollment. Acetaminophen may be used but must be documented in the medical record; 12. Subjects with a clinically significant history of drug or food allergy or atopic allergic disorders (e.g., asthma, urticaria, eczematous dermatitis); 13. Subjects who donated blood, participated as a subject in blood sampling, or experienced significant blood loss (>= 400 mL) within the past 3 months; 14. Subjects who participated in another clinical trial within the past 3 months (subjects who withdrew from a prior study prior to randomization or treatment may be enrolled in this study); 15. Subjects who are breastfeeding, have a positive pregnancy test, or have plans to conceive in the near future; 16. Subjects with difficulty with venipuncture, intolerance to needle insertion, or a history of syncope related to needles or blood; 17. Subjects who received any vaccination within the past month or who plan to receive a vaccination during the trial period; 18. Subjects whom the investigator considers to have other factors making them unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SAD pharmacokinetic (PK) parameters: AUC?–8, AUC?–t, Cmax, Tmax, t?/?z, ?z, CLz, Vz, AUC_%Extrap, MRT, etc.;SAD urinary pharmacokinetic (PK) parameters: Ae, Fe, CLR;MAD pharmacokinetic (PK) parameters: AUC?–8, AUC?–t, Cmax,ss, Tmax, t?/?z, ?z, CLss, Vz, MRT, AUC_%Extrap, Cmin,ss, Cmax,ss, Cav,ss, Swing, Ctrough,ss, AUC?–t,ss, fluctuation coefficient at steady state (DF), and accumulation ratio.; | — |
Countries
China
Contacts
Public ContactZhang Yu
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed