A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lipovirtide in HIV-infected Patients

Study Overview
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Brief Summary
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To evaluate the safety, tolerability of single dose lipovirtide injection in HIV-infected individuals without prior antiviral treatment, and to investigate the pharmacokinetic characteristics of infected patients.

Official Title
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A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lipovirtide in HIV-infected Patients Without Prior Antiviral Therapy

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Lipovirtide Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged from 18 to 60 (include 18 and 60)； Body mass index (BMI) [weight (kg)/ height 2(m2)] is from 18.0 to 26.0（include 18.0 and 26.0），male weight≥50kg，female weight≥45kg； Confirmed HIV-1 infection； HIV viral load ≥ 1000 copies/mL； Patients who have no birth plan within 2 weeks before the screening and 3 months after the end of the trial, consenting to take effective non-drug contraceptive measures during the trial period； Understand the purpose of and procedures required for the study and having confirmed they are willing to participate in the study by signing the informed consent document. Exclusion Criteria: Patients in the acute infection stage; Confirmed AIDS patients； Patients who have received antiviral therapy and/or have been vaccinated against HIV； HBsAg is (+), and/or anti-HCV is (+)； Abnormal liver function tests (ALT and / or AST> 3ULN, or total bilirubin> 2ULN)； Glomerular filtration rate <70mL/min/1.73m2, or creatinine ≥ULN； Patients who is currently suffering from a more serious chronic diseases, metabolic diseases (such as diabetes), neurological and mental diseases； Patients who have previous history of pancreatitis； Females who are pregnant or breastfeeding, or females of childbearing age who are unable to take contraception as required; Allergic constitution or known allergy to the components of study drug； With a history of smoking addiction within 12 months before screening (average number≥5 cigarettes per day)； With a history of alcohol abuse within 12 months before screening (average drinking≥14 units of alcohol per week: 1 unit = 285mL beer, 25mL spirits, or 150mL wine) or those who have a positive alcohol breath test before enrollment； With a history of drug abuse within 12 months before screening or those who tested positive for addictive substances before enrollment； Patients who have participated in other investigational drug study within 3 months before screening (except for traditional Chinese medicine）； Other factors that the investigators consider unsuitable for the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dose 5 mg | Drug: Lipovirtide Injection<br>* Single dosage of Lipovirtide Injection<br>|
| Experimental: 2<br>Dose 10 mg | Drug: Lipovirtide Injection<br>* Single dosage of Lipovirtide Injection<br>|
| Experimental: 3<br>Dose 20 mg | Drug: Lipovirtide Injection<br>* Single dosage of Lipovirtide Injection<br>|
| Experimental: 4<br>Dose 40 mg | Drug: Lipovirtide Injection<br>* Single dosage of Lipovirtide Injection<br>|
| Experimental: 5<br>Dose 60 mg | Drug: Lipovirtide Injection<br>* Single dosage of Lipovirtide Injection<br>|
| Experimental: 6<br>Dose 80 mg | Drug: Lipovirtide Injection<br>* Single dosage of Lipovirtide Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics：Cmax | pharmacokinetic characteristics of Lipovirtide in infected patients：Cmax | Day 0 to Day 7 | 
| Pharmacokinetics：AUC0-t | pharmacokinetic characteristics of Lipovirtide in infected patients：AUC0-t | Day 0 to Day 7 |