Status:
COMPLETED
Study to Evaluate Pharmacokinetic and Safety of Albuvirtide Between Intravenous Drip and Intravenous Injection
Lead Sponsor:
Frontier Biotechnologies Inc.
Conditions:
HIV/AIDS
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a single-center,randomized,open, single-dose, parallel-design study, which will be only enrolled Chinese healthy volunteers.
Detailed Description
30 Chinese volunteers will be enrolled to assess the pharmacokinetic and safety of Albuvirtide in two different Administration methods. All subjects are required to collect PK blood samples before and...
Eligibility Criteria
Inclusion
- Age of 18-55, healthy volunteers (including the threshold, based on time of signing informed consent form).
- BMI of 19 to 26 kg/m2 (including the threshold), with male ≥ 50 kg and female ≥ 45 kg.
- Subjects and their partners agreed never to have children from 2 weeks prior to screening until 6 months after administration and volunteered to use effective contraception, regardless of sperm or oocyte donation plans.
Exclusion
- Allergic to investigational drug or allergic constitution .
- With difficulty in intravenous administration/blood collection or a history of dizziness from needles and blood.
- Have substance abuse in the past 5 years or used drugs in the past 3 months prior to screening, or drug tested positive.
- Smoked an average of \>5 cigarettes per day in the 3 months prior to screening or were unable to stop using any tobacco-based products during the study.
- Consumption of an average of \>14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) in the past 3 months prior to screening, or inability to abstain from alcohol during the trial, or positive blood test for alcohol
- Any drugs that inhibit or induce hepatic CYP3A metabolizing enzymes (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - ketoconazole, itraconazole, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to screening.
- Any use of prescription, over-the-counter or herbal medicines and supplements within 14 days prior to screening
- Received vaccination within 4 weeks prior to screening or planned vaccination during the study.
- Consumption of dragon fruit, mango, grapefruit, carambola or food or drink prepared from them within 48 hours prior to admission.
- Have special requirements for diet.
- History or presence of any disease or condition which might compromise the Neurological, cardiovascular, hematological, hepatic, renal, gastrointestinal, respiratory, metabolic, endocrine, immune, and skeletal systems or any other body system.
- During the screening period, vital signs, physical examination, laboratory tests,12-lead electrocardiogram or chest radiograph is abnormal with clinically significant.
- During the screening period, virological testing, hepatitis B surface antigen or e antigen, hepatitis C antibody, syphilis spirochete antibody, or human immunodeficiency virus (HIV) antibody is positive.
- Women who tested positive for pregnancy at screening or baseline or lactating
- Participated in other drug clinical trials and took medication within 3 months prior to screening
Key Trial Info
Start Date :
February 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05206019
Start Date
February 16 2022
End Date
May 2 2022
Last Update
January 9 2023
Active Locations (1)
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1
The Second Hospital of Anhui Medical University
Hefei, China