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Study to Evaluate Pharmacokinetic and Safety of Albuvirtide Between Intravenous Drip and Intravenous Injection | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study to Evaluate Pharmacokinetic and Safety of Albuvirtide Between Intravenous Drip and Intravenous Injection

NCT05206019•Frontier Biotechnologies Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Age of 18-55, healthy volunteers (including the threshold, based on time of signing informed consent form).
•2. BMI of 19 to 26 kg/m2 (including the threshold), with male ≥ 50 kg and female ≥ 45 kg.
•3. 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.

Exclusion Criteria

•1. Allergic to investigational drug or allergic constitution .
•2. With difficulty in intravenous administration/blood collection or a history of dizziness from needles and blood.
•3. Have substance abuse in the past 5 years or used drugs in the past 3 months prior to screening, or drug tested positive.
•4. 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.
•5. 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
•6. 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.
•7. Any use of prescription, over-the-counter or herbal medicines and supplements within 14 days prior to screening
•8. Received vaccination within 4 weeks prior to screening or planned vaccination during the study.
•9. Consumption of dragon fruit, mango, grapefruit, carambola or food or drink prepared from them within 48 hours prior to admission.
•10. Have special requirements for diet.
+5 more criteria

Locations (1)

The Second Hospital of Anhui Medical University

Hefei, China

Key Dates

Start Date

February 16, 2022

Primary Completion Date

April 17, 2022

Completion Date

May 2, 2022

Last Updated

January 9, 2023

Enrollment

ACTUAL participants

Conditions

HIV/AIDS

Interventions

Albuvirtide

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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: January 9, 2023Data 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 to Evaluate Pharmacokinetic and Safety of Albuvirtide Between Intravenous Drip and Intravenous Injection

Inclusion Criteria

Exclusion Criteria

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