Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100

NCT05684705 | Completed Phase 1

• 1 other identifier: BV100-004
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (3)

• To assess plasma concentration of rifabutin in healthy participants

  Plasma concentration of rifabutin

  5 Days

• To assess epithelial lining fluid concentration of rifabutin in healthy participants

  Concentration of rifabutin in the epithelial lining fluid

  5 days

• To assess concentration of rifabutin in alveolar macrophages of healthy participants

  Concentration of rifabutin in the alveolar macrophages

  5 days

Secondary Outcomes (1)

• Safety and Tolerability of multiple dose administration of BV100 in healthy participants

  13 days

Study Arms (1)

BV100

EXPERIMENTAL

7 doses of BV100 (q12h)

Drug: BV100

Interventions

BV100 DRUG

Intravenous infusion

Also known as: Rifabutin for Infusion

BV100

Eligibility Criteria

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

You may qualify if:

• Participants who can understand and follow instructions during the study.
• Participants have been informed both verbally and in writing about the objectives of the clinical trial, the methods, the potential risks, and the discomfort to which he/she may be exposed and has given written consent to participation in the trial prior to trial start and any trial-related procedure.
• Healthy male participants ≥ 18 and ≤ 55 years of age, or female participants ≥ 18 and ≤ 55 years of age of non-childbearing potential defined as follows:
• female participants who underwent surgical sterilization
• female participants who underwent hysterectomy
• female participants with documented premature ovarian failure
• Healthy participants as defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, 12-lead ECG, vital signs, physical examination, spirometry (FEV1 \> 75% of predicted), and clinical laboratory tests.
• Weight within a BMI range of 19.0 30.0 kg/m2 inclusive.
• Healthy male participants with female partners of child-bearing potential must use two methods of contraception, one of which must be a barrier method (e.g., condom) to be used for the duration of the study and for 8 weeks after last IMP dose.
• Non-smokers, i.e., one who has abstained from use of tobacco or other nicotine containing products for at least 12 months, confirmed by negative cotinine test.
• Having had no febrile or significant infectious illness for at least one month prior to dosing.
• The subject is available to complete the study.
• The subject is able and willing to comply with the restrictions and requirements of the protocol and, in the opinion of the study physician, can complete the study.

You may not qualify if:

• As a result of the medical screening process, the study physician considered the subject unfit for the study.
• Known or suspected history of hypersensitivity to rifabutin or excipients or to drugs of a similar chemical class including rifampicin, rifapentine, rifaximin; history of allergic reactions leading to hospitalization or any other allergic conditions (including drug allergies, asthma, eczema, anaphylactic reactions but excluding untreated, asymptomatic, seasonal allergies) which the investigator considers may affect the safety of the subject and/or outcome of the study.
• History of antibiotic associated severe diarrhea within the last year.
• Any medication that inhibits tubular secretion (e.g., Probenecid, H2 receptor antagonists, trimethoprim) within 2 weeks prior to first dosing.
• Participants with ECG abnormalities (history, or evidence of second-degree heart block of Mobitz type II, third degree heart block, or any abnormality considered relevant by the investigator), QTcF \> 450 ms, PR \> 210 ms, or QRS duration \> 120 ms.
• Any clinical laboratory deviation that is assessed as clinically significant by the investigator (Note the exceptions mentioned in Ex 8 and 9)
• History of symptomatic, chronic or recurrent infection (e.g., nausea, vomiting, diarrhea, infection with fever) or any viral (including symptomatic herpes zoster), bacterial (including upper respiratory infection), fungal (non-cutaneous) or parasitic infection within 30 days prior to admission to the clinical unit.
• A positive pre-study serology test for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV)-1 and/or 2 antibodies.
• A positive drug/alcohol screen at screening or day -1.
• History of epilepsy, seizures, other neurological disorders, or neuropsychiatric conditions.
• Participants who have received any prescribed systemic or topical medication within 2 weeks of the first dose administration or five times the elimination half-life (whichever is longer).
• Participants who had used any non-prescribed systemic or topical medication (including herbal remedies) or megadose vitamins (i.e., 20 to 600 times the recommended daily supplement dose) within 7 days prior to dosing, unless in the opinion of the study physician the medication did not interfere with the study procedures or compromise safety.
• Participants who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 14 days of the first dose administration.
• Regular use of any inducer of metabolism (e.g., barbiturates, rifampin), or medications interfering with Cytochrome P450, Family 3, Subfamily A (CYP3A) are prohibited, comprising inducers, substrates, and inhibitors in the 3 months prior to the first admission to the clinical unit.
• Any medication that inhibits active tubular secretion (e.g. Probenecid, H2 receptor antagonists, trimethoprim) within 2 weeks prior to first dosing.

Sponsors & Collaborators

• BioVersys AG: lead
• CW-Research and Management GmbH: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, A-1090, Austria

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

Rifabutin

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Lisa Husband, MD

  BioVersys SAS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 13, 2023
• Study Start: September 1, 2023
• Primary Completion: October 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 14, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)