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

This is a single-center,randomized,open, single-dose, parallel-design study, which will be only enrolled Chinese healthy volunteers.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS
• Intervention / Treatment: Drug: Albuvirtide

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hefei, China
    • The Second Hospital of Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
11. 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.
12. During the screening period, vital signs, physical examination, laboratory tests,12-lead electrocardiogram or chest radiograph is abnormal with clinically significant.
13. 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.
14. Women who tested positive for pregnancy at screening or baseline or lactating
15. Participated in other drug clinical trials and took medication within 3 months prior to screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cohort 1: Albuvirtide; Single dose of 320 mg by intervenous drop infusion for 45 min	Drug: Albuvirtide; Long-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41)
Experimental: cohort 2: Albuvirtide; Single dose of 320 mg by intervenous injection for 0.5 min	Drug: Albuvirtide; Long-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41)
Experimental: cohort 3: Albuvirtide; Single dose of 320 mg by intervenous injection for 3 min	Drug: Albuvirtide; Long-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under curve	The area under the plase of the last measurable The area under the curve of the last measurable concentration (AUCt)	Day 0-Day 57
Peak concentration	Maximum observed plasma concentration (Cmax)	Day 0-Day 57
Peak time	Time to Cmax ( Tmax)	Day 0-Day 57
half-time	Time for blood concentration to drop by half-time（t1/2）	Day 0-Day 57

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	Incidence of Treatment-Emergent Adverse Events	Day 0-Day 63

Collaborators and Investigators

• Sponsor: Frontier Biotechnologies Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2022
• Primary Completion (Actual): April 17, 2022
• Study Completion (Actual): May 2, 2022

Study Registration Dates

• First Submitted: December 30, 2021
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Estimate): January 9, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: FB-ABWT-402

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No