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

Sponsor

Shanxi Kangbao Biological Product Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04592315

Collaborator

Chinese Academy of Medical Sciences (Other)

Enrollment

Location

Arms

8.6

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Lipovirtide Injection	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 23, 2021

Anticipated Primary Completion Date :

Aug 12, 2021

Anticipated Study Completion Date :

Oct 12, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Pharmacokinetics：Cmax [Day 0 to Day 7]
pharmacokinetic characteristics of Lipovirtide in infected patients：Cmax
Pharmacokinetics：AUC0-t [Day 0 to Day 7]
pharmacokinetic characteristics of Lipovirtide in infected patients：AUC0-t

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing You'an Hospital, Beijing Medical University	Beijing	Beijing	China

Sponsors and Collaborators

Shanxi Kangbao Biological Product Co., Ltd.
Chinese Academy of Medical Sciences

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanxi Kangbao Biological Product Co., Ltd.

ClinicalTrials.gov Identifier:

NCT04592315

Other Study ID Numbers:

KB-LP-80-101

First Posted:

Oct 19, 2020

Last Update Posted:

Jul 15, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

HIV Infections

Study Results

No Results Posted as of Jul 15, 2021