COVID-19 Pneumonia
Conditions
Brief summary
This si a single-center, non-randomized, open, parallel, single-dose trial was designed to evaluate the safety and pharmacokinetic characteristics of GST-HG171 tablets in subjects with impaired renal function.
Interventions
150mg GST-HG171 100mg Tablets and ritonavir
Sponsors
Fujian Akeylink Biotechnology Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
All subjects are required to meet all of the following conditions 1. Voluntarily sign informed consent prior to the start of activities related to this study, be able to understand the procedures and methods of this study, and be willing to strictly follow the clinical trial protocol to complete this study; 2. Subjects (including their partners) are willing to have no family planning and voluntarily take highly effective contraception within 6 months after the last study drug administration; 3. Age range from 18 to 70 (including both ends) on the date of signing the informed consent, both male and female; 4. Male subjects weigh at least 50 kg and female subjects weigh at least 45 kg; Body mass index (BMI) 18-32 kg/m2 (including both ends); Subjects with normal renal function should also meet all of the following conditions: 5. Physical examination, vital signs and electrocardiogram are normal or abnormal without clinical significance; 6. The glomerular filtration rate should meet the following criteria: Subjects with normal renal function: GFR≥90 mL/min; 7. The following demographic matching criteria must be met during screening: 1. The body weight was matched with that of the renal impairment group, with an average of ±10 kg; 2. Age matching was performed with the renal impairment group, with the mean ±10 years old; 3. Gender matching was performed with the group of renal impairment, with the mean ±1 case; Subjects with renal impairment should also meet all of the following conditions: 8. Have chronic kidney disease (CKD), have any indicators of kidney injury or have a GFR less than 60 mL/min for more than 3 months (outpatient medical records, inpatient records or laboratory records can be used as evidence); 9. The glomerular filtration rate shall meet the following criteria: Subjects with mild renal impairment (stage CKD2) : 60-89 mL/min (including values at both ends), subjects with moderate renal impairment (stage CKD3) : 30-59 mL/min (including values at both ends), subjects with severe renal impairment (stage CKD4) : 15-29 mL/min (including both ends); 10. Renal function was stable, and GFR results of two tests before administration (at least 3 days apart) should be in the same CKD stage; 11. Except for renal dysfunction and complications, the investigator judged that the physical condition was good based on medical history inquiry, comprehensive physical examination, routine laboratory examination (blood routine, blood biochemistry, urine routine, coagulation function, etc.), 12-lead electrocardiogram, chest X-ray (orthographic), abdominal B-ultrasound examination, etc.
Exclusion criteria
Subjects meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma concentration (Cmax) for GST-HG171 | Day 1 (predose), 0.25,0.5 ,0.75,1 ,1.25,1.5,2 ,3 ,4 ,6 ,8 ,12,24 ,48 and 72 hours post-dose | Maximum observed plasma GST-HG171 concentration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AEs | up to Day 10 | To evaluate the safety and tolerability of GST-HG171 tablets in subjects with impaired renal function. |
Countries
China
Outcome results
None listed