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

NCT04592315 | Completed Phase 1

• 1 other identifier: KB-LP-80-101
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pharmacokinetic characteristics- Area Under the Plasma Concentration Versus Time Curve (AUC)

  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)

  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."

Study Arms (6)

1

EXPERIMENTAL

Dose 5 mg

Drug: Lipovirtide Injection

2

EXPERIMENTAL

Dose 10 mg

Drug: Lipovirtide Injection

3

EXPERIMENTAL

Dose 20 mg

Drug: Lipovirtide Injection

4

EXPERIMENTAL

Dose 40 mg

Drug: Lipovirtide Injection

5

EXPERIMENTAL

Dose 60 mg

Drug: Lipovirtide Injection

6

EXPERIMENTAL

Dose 80 mg

Drug: Lipovirtide Injection

Interventions

Lipovirtide Injection DRUG

Single dosage of Lipovirtide Injection

1; 2; 3; 4; 5; 6

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator
• Shanxi Kangbao Biological Product Co., Ltd.: lead

Study Sites (1)

Beijing You'an Hospital, Beijing Medical University

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Haibin Yu, MD

  Beijing You'an Hospital, Beijing Medical University

  PRINCIPAL INVESTIGATOR

• Hao Wu, MD

  Beijing You'an Hospital, Beijing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 19, 2020
• Study Start: January 23, 2021
• Primary Completion: May 2, 2023
• Study Completion: July 11, 2023
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

CN (1)