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Study for Evaluation of the Safety, Pharmacokinetics, and Antiviral Activity of UB-421 Subcutaneous Formulation in HIV Infected Adults | Clinical Trials | Clareo Health

UNKNOWNPHASE1

Study for Evaluation of the Safety, Pharmacokinetics, and Antiviral Activity of UB-421 Subcutaneous Formulation in HIV Infected Adults

A Phase I, Open-Label, Multi-Dose Study for Evaluation of the Safety, Pharmacokinetics, and Antiviral Activity of UB-421 Subcutaneous Formulation in HIV Infected Adults

NCT04620291•United BioPharma

View on ClinicalTrials.gov

Summary

UB-421 subcutaneous formulation (UB-421 SC) is developed to provide HIV infected patients a more convenient drug delivery method. UB-421 SC injection, with significantly less injection time than IV infusions and with opportunity of self-administration or administered in general medical setting (in addition to HIV-specific clinic), can provide patient a more convenient option. This UB-421 SC phase I study will be conducted to investigate short-term safety, pharmacokinetics and anti-viral activity of UB-421 SC at three dose levels in ART-treated aviremic subjects and treatment naive HIV-infected subjects. The current UB-421 SC formulation (125 mg/ml) is at least 10-fold more concentrated than UB-421 IV (10 mg/ml). The highly concentrated formulation makes weekly UB-421 subcutaneous injections feasible. This study will form the basis of UB-421 SC in combination with antiretroviral agents (ARV) for treating HIV infected viremic patients in the future clinical trials.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The blips are \<400 copies/mL, and
•Part B:
•D. HIV-1 viral load \>200 copies/mL at the SV; E. HIV antiretroviral therapy (ART)-naïve i.e., subjects who receive no prior or current ART.
•However, subjects who have previously received pre- or post-exposure prophylaxis but eventually confirmed HIV-1 seropositive can be enrolled; F. Asymptomatic (generalized lymphadenopathy can be included), defined as subjects without stage 3 defining opportunistic illnesses according to revised Surveillance Case Definition for HIV Infection published in 2014, which was determined by the Investigator based on the medical history, physical examination, ECG, and laboratory evaluations;
•1. HIV-1 seropositive, with documented HIV-1 infection by official, signed, written history (e.g.
•laboratory report);
•2. Male and female, age 18 years or older;
•3. CD4+ (D1) T cell count \> 350 cells/mm3 at the SV;
•4. Male subjects and female subjects of childbearing potential must agree to use the acceptable method of contraception during the course of the study (excluding women who are not of childbearing potential). Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at the SV; Definitions Women NOT of childbearing potential: women who are permanently or surgically sterilized or postmenopausal. Permanent sterilization includes hysterectomy, and/or bilateral oophorectomy, and/or bilateral salpingectomy and/or tubal ligation.
•Postmenopausal women: 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. Acceptable method of birth control for WOCBP: abstinence; implant; intrauterine device; hormonal contraceptive (injectable, oral contraceptives, transdermal patches, or contraceptive rings) plus barrier method (male condom, female condom or diaphragm). Acceptable method of birth control for male subjects: abstinence; condom.
+1 more criteria

Exclusion Criteria

•Subjects who have any of the following conditions will be excluded from both Part A and B
•1. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study;
•2. Subjects with acute opportunistic infection(s) or bacterial infection(s), that the delayed initiation of ART would not be allowed, as judged by the Investigator;
•3. Any stage 3 defining opportunistic illnesses such as Kaposi's sarcoma according to the revised Surveillance Case Definition for HIV Infection published in 2014 within the past 12 months before the SV;
•4. Serious illness requiring systemic treatment and/or hospitalization for at least 7 days prior to the SV;
•5. Any previous exposure to a monoclonal antibody within 12 weeks prior to the SV;
•6. Any previous hypersensitivity reaction to monoclonal antibody;
•7. Have ever experienced urticaria in the previous 2 years before the SV or with ongoing dermatologic problem with rash appearance (eg. eczema, atopic dermatitis, urticaria) at the SV;
•8. Any significant diseases (other than HIV-1 infection) or clinically significant findings that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy;
•9. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones);
+11 more criteria

Key Dates

Start Date

December 31, 2023

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2025

Last Updated

May 13, 2022

Enrollment

ESTIMATED participants

Conditions

HIV-1-infection

Interventions

UB-421 SC

BIOLOGICAL

Contacts

Linda Shih, Master

CONTACT

+886-3-668-4800 linda.shih@unitedbiopharma.com

Zhonghao Shi

CONTACT

+886-3-668-4800 zhonghao.shi@unitedbiopharma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 13, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study for Evaluation of the Safety, Pharmacokinetics, and Antiviral Activity of UB-421 Subcutaneous Formulation in HIV Infected Adults

Inclusion Criteria

Exclusion Criteria

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