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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Lipovirtide Injection

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Beijing You'an Hospital, Beijing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or female aged from 18 to 60 (include 18 and 60)；
2. 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；
3. Confirmed HIV-1 infection；
4. HIV viral load ≥ 1000 copies/mL；
5. 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；
6. 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:

1. Patients in the acute infection stage;
2. Confirmed AIDS patients；
3. Patients who have received antiviral therapy and/or have been vaccinated against HIV；
4. HBsAg is (+), and/or anti-HCV is (+)；
5. Abnormal liver function tests (ALT and / or AST> 3ULN, or total bilirubin> 2ULN)；
6. Glomerular filtration rate <70mL/min/1.73m2, or creatinine ≥ULN；
7. Patients who is currently suffering from a more serious chronic diseases, metabolic diseases (such as diabetes), neurological and mental diseases；
8. Patients who have previous history of pancreatitis；
9. Females who are pregnant or breastfeeding, or females of childbearing age who are unable to take contraception as required;
10. Allergic constitution or known allergy to the components of study drug；
11. With a history of smoking addiction within 12 months before screening (average number≥5 cigarettes per day)；
12. 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；
13. With a history of drug abuse within 12 months before screening or those who tested positive for addictive substances before enrollment；
14. Patients who have participated in other investigational drug study within 3 months before screening (except for traditional Chinese medicine）；
15. Other factors that the investigators consider unsuitable for the trial.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Dose 5 mg	Drug: Lipovirtide Injection; Single dosage of Lipovirtide Injection
Experimental: 2; Dose 10 mg	Drug: Lipovirtide Injection; Single dosage of Lipovirtide Injection
Experimental: 3; Dose 20 mg	Drug: Lipovirtide Injection; Single dosage of Lipovirtide Injection
Experimental: 4; Dose 40 mg	Drug: Lipovirtide Injection; Single dosage of Lipovirtide Injection
Experimental: 5; Dose 60 mg	Drug: Lipovirtide Injection; Single dosage of Lipovirtide Injection
Experimental: 6; Dose 80 mg	Drug: Lipovirtide Injection; Single dosage of Lipovirtide Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Treatment-Related Adverse Events as Assessed by DAIDS v1.0	Evaluation of safety and tolerability after single dose of injectable Lipivirtide in HIV-infected patients not receiving antiretroviral therapy	Day 1 to Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic characteristics- Area Under the Plasma Concentration Versus Time Curve (AUC)	Evaluation of the pharmacokinetic properties of injectable Lipovirtide after single dose in HIV-infected patients not receiving antiretroviral therapy, to obtain pharmacokinetic parameters.	Area Under the Plasma Concentration Versus Time Curve (AUC) of Lipovirtide could have a time frame of "0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 30, 36h, 4, 72, 96, 120, 168 hours post-dose."
Pharmacokinetic characteristics-Peak plasma concentration (Cmax)	Evaluation of the pharmacokinetic properties of injectable Lipovirtide after single dose in HIV-infected patients not receiving antiretroviral therapy, to obtain pharmacokinetic parameters.	Peak plasma concentration (Cmax) of Lipovirtide could have a time frame of "0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 30, 36h, 4, 72, 96, 120, 168 hours post-dose."

Collaborators and Investigators

• Sponsor: Shanxi Kangbao Biological Product Co., Ltd.
• Collaborators: Institute of Pathogen Biology, Beijing, China
• Investigators: Principal Investigator: Haibin Yu, MD, Beijing You'an Hospital, Beijing Medical University; Principal Investigator: Hao Wu, MD, Beijing You'an Hospital, Beijing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2021
• Primary Completion (Actual): May 2, 2023
• Study Completion (Actual): July 11, 2023

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: October 14, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: KB-LP-80-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No