HIV-1-infectionPhase 1NCT04620291
Study for Evaluation of the Safety, Pharmacokinetics, and Antiviral Activity of UB-421 Subcutaneous Formulation in HIV Infected Adults
A Phase 1 study testing UB-421 SC in people with HIV-1-infection, run by United BioPharma.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- UB-421 SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2023to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ART-treated aviremic subjects who meet all inclusion criteria (A~C and 1~5) will be eligible for Part A: A. Documentation of continuous ART treatment with suppression of plasma viral level below the limit of detection for ≥1 years. Individuals with "blips" (i.e., detectable viral levels on ART) prior to the Screening Visit (SV) may be included provided they satisfy the following criteria:
- The blips are <400 copies/mL, and
- Succeeding viral levels return to levels below the limit of detection on subsequent testing B. Tolerated the baseline ART regimen (without major toxicity) and are expected to continue in the trial period (since SV till EOS) the same ART regimen. The change in brand or formulation but not in the 3 ARV types (eg, from 3 tablets to 1 single tablet containing the same 3 ARV drugs, or from immediate-release to extended-release tablet per day, or other similar change are allowed) are considered the same ART regimen; C. Viral load should below 50 RNA copies/mL at the SV; ART-naïve viremic subjects who meet all inclusion criteria (D~F and 1~5) will be eligible for
- Part B:
- 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;
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- HIV-1 seropositive, with documented HIV-1 infection by official, signed, written history (e.g.
- laboratory report);
- Male and female, age 18 years or older;
- CD4+ (D1) T cell count > 350 cells/mm3 at the SV;
- 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.
- Subjects signed the informed consent before undergoing any study procedures.
Who cannot join
- Subjects who have any of the following conditions will be excluded from both Part A and B
- Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study;
- 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;
- 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;
- Serious illness requiring systemic treatment and/or hospitalization for at least 7 days prior to the SV;
- Any previous exposure to a monoclonal antibody within 12 weeks prior to the SV;
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- Any previous hypersensitivity reaction to monoclonal antibody;
- 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;
- 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;
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones);
- Presence of hepatitis B surface antigen (HBsAg) or HCV antibody and RNA double positive at the Screening Visit or within 12 weeks prior to the SV;
- Serum GPT/ALT value is 2.5 times or greater than the upper limit of normal (≥ 2.5 xULN) at the Screening Visit;
- Serum GOT/AST value is 2.5 times or greater than the upper limit of normal (≥ 2.5 xULN) at the Screening Visit;
- Serum total bilirubin (TBIL) value is 2.5 times or greater than the upper limit of normal (≥ 2.5 xULN) at the SV;
- Serum creatinine value is greater than 1.5 times the upper limit of normal (> 1.5 x ULN) at the SV;
- Any vaccination within 8 weeks prior to the SV;
- Any treatment with immunomodulators, such as interleukins, interferon, cyclosporine, systemic corticosteroid, or systemic chemotherapy within 12 weeks prior to the Screening Visit; Note: Subjects received short-term low dose oral (i.e. prednisone ≤0.5mg/kg/day f or ≤ 1 - month duration), inhaled, nasal, or topical steroids will not be excluded.)
- Prior participation in any HIV vaccine trial;
- Receipt of other investigational study agent within 12 weeks before the SV;
- Life expectancy of less than 12 months;
- Any current alcohol or illicit drug use that, in the Investigator's opinion, would interfere with the subject's ability to comply with the dosing and visit schedules and protocol evaluations
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
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.
- Conditions
- HIV-1-infection
- Being tested
- UB-421 SC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UB-421 SCBiological
Also called Humanized dB4C7C22-6 monoclonal antibody
The UB-421 SC (dB4C7C22-6 mAb) will be supplied at a concentration of 125 mg/mL after reconstitution. Subjects will receive weekly UB-421 SC injections during the 4-week Treatment Period.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | 250 mg UB-421 SC: ART-treated subjects Receives: Biological: UB-421 SC |
| Cohort B | Experimental | 500 mg UB-421 SC: ART-treated subjects Receives: Biological: UB-421 SC |
| Cohort C | Experimental | 700 mg UB-421 SC: ART-treated subjects Receives: Biological: UB-421 SC |
| Cohort D | Experimental | 500 mg UB-421 SC: Treatment naive subjects Receives: Biological: UB-421 SC |
| Cohort E | Experimental | 700 mg UB-421 SC: Treatment naive subjects Receives: Biological: UB-421 SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers and incidence of TEAEs
Numbers and incidence of TEAEs that are ≥ Grade 2 and study treatment related, TEAEs (any grades) by maximum severity, TEAEs by relationship to study treatment, SAEs, TEAEs leading to death, and TEAEs leading to discontinuation of study treatment will be tabulated by dose cohort and will be summarized by system organ class and preferred term for study period (Treatment or Follow-up). The "Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events" will be used in this study for all AE severity grading, except skin abnormalities, which will be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE).
Measured: 28 days
Secondary outcomes (4)
The virologic responses during the Treatment Period
The proportion of subjects ever achieving HIV-1 RNA reduction > X log10 copies/mL;
Measured: 28 days
PK of UB-421 SC
- Ctrough for each dosing interval;
Measured: 28 days
PK of UB-421 SC
Cmax of first dosing interval;
Measured: 28 days
PK of UB-421 SC
AUC0-inf (if applicable).
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start31 Dec 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620291
- Sponsor's protocol ID
- UBP-A127-HIV
- Status last verified
- May 2022
- First submitted
- 28 Oct 2020
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04620291
- Acronym / sponsor ID
- UBP-A127-HIV
- Conditions
- HIV-1-infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- United BioPharmaIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Biological: UB-421 SC250 mg UB-421 SC: ART-treated subjects |
| Cohort B | Experimental | Biological: UB-421 SC500 mg UB-421 SC: ART-treated subjects |
| Cohort C | Experimental | Biological: UB-421 SC700 mg UB-421 SC: ART-treated subjects |
| Cohort D | Experimental | Biological: UB-421 SC500 mg UB-421 SC: Treatment naive subjects |
| Cohort E | Experimental | Biological: UB-421 SC700 mg UB-421 SC: Treatment naive subjects |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- ART-treated aviremic subjects who meet all inclusion criteria (A~C and 1~5) will be eligible for Part A: A. Documentation of continuous ART treatment with suppression of plasma viral level below the limit of detection for ≥1 years. Individuals with "blips" (i.e., detectable viral levels on ART) prior to the Screening Visit (SV) may be included provided they satisfy the following criteria:
- The blips are <400 copies/mL, and
- Succeeding viral levels return to levels below the limit of detection on subsequent testing B. Tolerated the baseline ART regimen (without major toxicity) and are expected to continue in the trial period (since SV till EOS) the same ART regimen. The change in brand or formulation but not in the 3 ARV types (eg, from 3 tablets to 1 single tablet containing the same 3 ARV drugs, or from immediate-release to extended-release tablet per day, or other similar change are allowed) are considered the same ART regimen; C. Viral load should below 50 RNA copies/mL at the SV; ART-naïve viremic subjects who meet all inclusion criteria (D~F and 1~5) will be eligible for
- 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;
Key exclusion criteria (21 listed)
- Subjects who have any of the following conditions will be excluded from both Part A and B
- Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study;
- 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;
- 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;
- Serious illness requiring systemic treatment and/or hospitalization for at least 7 days prior to the SV;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UB-421 SCAlso: Humanized dB4C7C22-6 monoclonal antibodyThe UB-421 SC (dB4C7C22-6 mAb) will be supplied at a concentration of 125 mg/mL after reconstitution. Subjects will receive weekly UB-421 SC injections during the 4-week Treatment Period. | Biological | Cohort A, Cohort B, Cohort C, Cohort D, Cohort E |
Primary outcome
Numbers and incidence of TEAEs
Time frame: 28 days
Numbers and incidence of TEAEs that are ≥ Grade 2 and study treatment related, TEAEs (any grades) by maximum severity, TEAEs by relationship to study treatment, SAEs, TEAEs leading to death, and TEAEs leading to discontinuation of study treatment will be tabulated by dose cohort and will be summarized by system organ class and preferred term for study period (Treatment or Follow-up). The "Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events" will be used in this study for all AE severity grading, except skin abnormalities, which will be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE).
4 secondary outcomes
The virologic responses during the Treatment Period
Time frame: 28 days
PK of UB-421 SC
Time frame: 28 days
PK of UB-421 SC
Time frame: 28 days
PK of UB-421 SC
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UB-421 SC in people with HIV-1-infection, run by United BioPharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda Shih, Master (+886-3-668-4800 ext. 3641, linda.shih@unitedbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers and incidence of TEAEs (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.