HIV/AIDSPhase 1NCT05206019
Study to Evaluate Pharmacokinetic and Safety of Albuvirtide Between Intravenous Drip and Intravenous Injection
A Phase 1 study testing Albuvirtide in people with HIV/AIDS, run by Frontier Biotechnologies Inc. at 1 site in China.
Trial summary
This is a single-center,randomized,open, single-dose, parallel-design study, which will be only enrolled Chinese healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Albuvirtide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2022to 2 May 2022
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age of 18-55, healthy volunteers (including the threshold, based on time of signing informed consent form).
- BMI of 19 to 26 kg/m2 (including the threshold), with male ≥ 50 kg and female ≥ 45 kg.
- Subjects and their partners agreed never to have children from 2 weeks prior to screening until 6 months after administration and volunteered to use effective contraception, regardless of sperm or oocyte donation plans.
Who cannot join
- Allergic to investigational drug or allergic constitution .
- With difficulty in intravenous administration/blood collection or a history of dizziness from needles and blood.
- Have substance abuse in the past 5 years or used drugs in the past 3 months prior to screening, or drug tested positive.
- Smoked an average of >5 cigarettes per day in the 3 months prior to screening or were unable to stop using any tobacco-based products during the study.
- Consumption of an average of >14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) in the past 3 months prior to screening, or inability to abstain from alcohol during the trial, or positive blood test for alcohol
- Any drugs that inhibit or induce hepatic CYP3A metabolizing enzymes (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - ketoconazole, itraconazole, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to screening.
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- Any use of prescription, over-the-counter or herbal medicines and supplements within 14 days prior to screening
- Received vaccination within 4 weeks prior to screening or planned vaccination during the study.
- Consumption of dragon fruit, mango, grapefruit, carambola or food or drink prepared from them within 48 hours prior to admission.
- Have special requirements for diet.
- History or presence of any disease or condition which might compromise the Neurological, cardiovascular, hematological, hepatic, renal, gastrointestinal, respiratory, metabolic, endocrine, immune, and skeletal systems or any other body system.
- During the screening period, vital signs, physical examination, laboratory tests,12-lead electrocardiogram or chest radiograph is abnormal with clinically significant.
- During the screening period, virological testing, hepatitis B surface antigen or e antigen, hepatitis C antibody, syphilis spirochete antibody, or human immunodeficiency virus (HIV) antibody is positive.
- Women who tested positive for pregnancy at screening or baseline or lactating
- Participated in other drug clinical trials and took medication within 3 months prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
This is a single-center,randomized,open, single-dose, parallel-design study, which will be only enrolled Chinese healthy volunteers.
Read the detailed description
30 Chinese volunteers will be enrolled to assess the pharmacokinetic and safety of Albuvirtide in two different Administration methods. All subjects are required to collect PK blood samples before and after administration.
30 healthy subjects will be randomized into three cohorts ( cohorts A, B and C) in 1:1:1 ratio, with 10 subjects in each cohort. The subjects will receive a single dose of 320 mg of albuvirtide by iv infusion for 45 min or by iv bolus for 0.5 min or 3 min, respectively.
- Conditions
- HIV/AIDS
- Being tested
- Albuvirtide
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbuvirtideDrug
Long-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41)
| Study group | Role | What they receive |
|---|---|---|
| cohort 1: Albuvirtide | Experimental | Single dose of 320 mg by intervenous drop infusion for 45 min Receives: Drug: Albuvirtide |
| cohort 2: Albuvirtide | Experimental | Single dose of 320 mg by intervenous injection for 0.5 min Receives: Drug: Albuvirtide |
| cohort 3: Albuvirtide | Experimental | Single dose of 320 mg by intervenous injection for 3 min Receives: Drug: Albuvirtide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve
The area under the plase of the last measurable The area under the curve of the last measurable concentration (AUCt)
Measured: Day 0-Day 57
Peak concentration
Maximum observed plasma concentration (Cmax)
Measured: Day 0-Day 57
Peak time
Time to Cmax ( Tmax)
Measured: Day 0-Day 57
half-time
Time for blood concentration to drop by half-time（t1/2）
Measured: Day 0-Day 57
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events
Measured: Day 0-Day 63
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start16 Feb 2022
- Primary completion17 Apr 2022
- Study completion2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frontier Biotechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206019
- Sponsor's protocol ID
- FB-ABWT-402
- Status last verified
- Jan 2023
- First submitted
- 30 Dec 2021
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate Pharmacokinetic and Safety of Albuvirtide Between Intravenous Drip and Intravenous Injection
- ClinicalTrials.gov ID
- NCT05206019
- Acronym / sponsor ID
- FB-ABWT-402
- Conditions
- HIV/AIDS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Frontier Biotechnologies Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 17 Apr 2022 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 25 Jan 2022 (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.
This is a single-center,randomized,open, single-dose, parallel-design study, which will be only enrolled Chinese healthy volunteers.
Detailed description
30 Chinese volunteers will be enrolled to assess the pharmacokinetic and safety of Albuvirtide in two different Administration methods. All subjects are required to collect PK blood samples before and after administration.
30 healthy subjects will be randomized into three cohorts ( cohorts A, B and C) in 1:1:1 ratio, with 10 subjects in each cohort. The subjects will receive a single dose of 320 mg of albuvirtide by iv infusion for 45 min or by iv bolus for 0.5 min or 3 min, respectively.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cohort 1: Albuvirtide | Experimental | Drug: AlbuvirtideSingle dose of 320 mg by intervenous drop infusion for 45 min |
| cohort 2: Albuvirtide | Experimental | Drug: AlbuvirtideSingle dose of 320 mg by intervenous injection for 0.5 min |
| cohort 3: Albuvirtide | Experimental | Drug: AlbuvirtideSingle dose of 320 mg by intervenous injection for 3 min |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age of 18-55, healthy volunteers (including the threshold, based on time of signing informed consent form).
- BMI of 19 to 26 kg/m2 (including the threshold), with male ≥ 50 kg and female ≥ 45 kg.
- Subjects and their partners agreed never to have children from 2 weeks prior to screening until 6 months after administration and volunteered to use effective contraception, regardless of sperm or oocyte donation plans.
Key exclusion criteria (15 listed)
- Allergic to investigational drug or allergic constitution .
- With difficulty in intravenous administration/blood collection or a history of dizziness from needles and blood.
- Have substance abuse in the past 5 years or used drugs in the past 3 months prior to screening, or drug tested positive.
- Smoked an average of >5 cigarettes per day in the 3 months prior to screening or were unable to stop using any tobacco-based products during the study.
- Consumption of an average of >14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) in the past 3 months prior to screening, or inability to abstain from alcohol during the trial, or positive blood test for alcohol
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 |
|---|---|---|
| AlbuvirtideLong-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41) | Drug | cohort 1: Albuvirtide, cohort 2: Albuvirtide, cohort 3: Albuvirtide |
Primary outcome
Area under curve
Time frame: Day 0-Day 57
The area under the plase of the last measurable The area under the curve of the last measurable concentration (AUCt)
Peak concentration
Time frame: Day 0-Day 57
Maximum observed plasma concentration (Cmax)
Peak time
Time frame: Day 0-Day 57
Time to Cmax ( Tmax)
half-time
Time frame: Day 0-Day 57
Time for blood concentration to drop by half-time（t1/2）
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Day 0-Day 63
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Albuvirtide in people with HIV/AIDS, run by Frontier Biotechnologies Inc. at 1 site in China.
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 3 inclusion and 15 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: finished, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under curve (time frame: Day 0-Day 57). The study lists 4 primary outcomes in all. 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 9 Jan 2023.