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

NCT05206019 | Completed Phase 1 FDA Drug

• 1 other identifier: FB-ABWT-402
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Day 0-Day 63

Study Arms (3)

cohort 1: Albuvirtide

EXPERIMENTAL

Single dose of 320 mg by intervenous drop infusion for 45 min

Drug: Albuvirtide

cohort 2: Albuvirtide

EXPERIMENTAL

Single dose of 320 mg by intervenous injection for 0.5 min

Drug: Albuvirtide

cohort 3: Albuvirtide

EXPERIMENTAL

Single dose of 320 mg by intervenous injection for 3 min

Drug: Albuvirtide

Interventions

Albuvirtide DRUG

Long-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41)

cohort 1: Albuvirtide; cohort 2: Albuvirtide; cohort 3: Albuvirtide

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Frontier Biotechnologies Inc.: lead

Study Sites (1)

The Second Hospital of Anhui Medical University

Hefei, China

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

albuvirtide

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 25, 2022
• Study Start: February 16, 2022
• Primary Completion: April 17, 2022
• Study Completion: May 2, 2022
• Last Updated: January 9, 2023

Record last verified: 2023-01

Locations

CN (1)