Bacterial InfectionsPhase 1NCT05684705
Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100
A Phase 1 study testing BV100 in people with Bacterial Infections, run by BioVersys AG at 1 site in Austria.
Trial summary
Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- BV100
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteAustria
- Study dates
- 1 Sep 2023to 30 Dec 2024
- 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
- 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 50 years of age or older, in menopause for 24 consecutive months and not receiving any hormone replacement therapy within 24 months prior to inclusion into the study
- female participants who underwent surgical sterilization
- female participants who underwent hysterectomy
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- 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.
Who cannot join
- As a result of the medical screening process, the study physician considered the subject unfit for the study.
- Pregnant or lactating women, or men with female partners, who are not willing to use contraception as defined in inclusion criterion #6.
- 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.
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- Supine systolic blood pressure > 140 mm Hg or < 90 mm Hg or diastolic blood pressure > 90 mm Hg or < 45 mm Hg at Screening or Day 1 prior to dosing (any abnormal blood pressure results may be repeated once and if the repeat result is within the normal range, it is not considered to have met the exclusion criterion). Pulse rate> 90 bpm or < 45 bpm at Screening.
- Clinically relevant abnormal values for leukocytes (total WBC), neutrophils, and lymphocytes (total), or values below the lower limit of normal (LLN) at screening. Any abnormal value of these parameters may be repeated and if the repeat result is within the laboratory reference range or not considered relevant by the investigator, it is not considered to have met the exclusion criterion.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and creatinine, above the ULN at Screening. Any abnormal value of these parameters may be repeated and if the repeat result is within the laboratory reference range, it is not considered to have met the exclusion criterion.
- 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.
- Participants who have participated in a clinical study involving administration of an investigational drug (new chemical entity) within the following time-period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Participants who consume more than 21 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse (one unit of alcohol equals 285 mL of beer [½ pint], one glass [125 mL] of wine, or 30 mL of 40% alcohol by volume distilled spirits).
- Excessive consumption of caffeine- or xanthine-containing food or beverages (> 5 cups of coffee a day or equivalent) or inability to stop consuming from 48 hours prior to administration of study treatment.
- Any use of drugs-of-abuse or alcohol abuse within 2 years prior to the first admission to the clinical unit.
- Inability to understand or communicate reliably with the investigator or considered by the investigator to be unable to or unlikely to co-operate with the requirements of the study.
- Any other conditions or factors which in the opinion of the investigator may interfere with study conduct. Failure to satisfy the investigator of fitness to participate for any other reason.
- Any significant blood loss: donated one unit (450 mL) of blood or more or received a transfusion of any blood or blood products within 60 days, or donated plasma within 7 days prior to the first admission to the clinical unit.
- Participants who are study site employees or immediate family members of the study site or sponsor employees.
- Suspected SARS CoV 2 infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Open-label Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100 (rifabutin for Infusion) in Healthy Participants
Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100
Read the detailed description
This is a single center, open-label, monocentric, multiple IV dose, phase I study to investigate the penetration of rifabutin into the lung after multiple intravenous administrations of BV100 (rifabutin for infusion) in healthy participants.
- Conditions
- Bacterial Infections
- Being tested
- BV100
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BV100Drug
Also called Rifabutin for Infusion
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| BV100 | Experimental | 7 doses of BV100 (q12h) Receives: Drug: BV100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess plasma concentration of rifabutin in healthy participants
Plasma concentration of rifabutin
Measured: 5 Days
To assess epithelial lining fluid concentration of rifabutin in healthy participants
Concentration of rifabutin in the epithelial lining fluid
Measured: 5 days
To assess concentration of rifabutin in alveolar macrophages of healthy participants
Concentration of rifabutin in the alveolar macrophages
Measured: 5 days
Secondary outcomes (1)
Safety and Tolerability of multiple dose administration of BV100 in healthy participants
Number of Participants with Treatment-Emergent Adverse Events
Measured: 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start1 Sep 2023
- Primary completion30 Oct 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioVersys AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CW-Research and Management GmbH
- Responsible party
- Sponsor
- Investigators
- Lisa Husband, MD, Study director, BioVersys SAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684705
- Sponsor's protocol ID
- BV100-004
- Status last verified
- Aug 2024
- First submitted
- 5 Jan 2023
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open-label Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100 (rifabutin for Infusion) in Healthy Participants
- ClinicalTrials.gov ID
- NCT05684705
- Acronym / sponsor ID
- BV100-004
- Conditions
- Bacterial Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- BioVersys AGIndustry (pharma, biotech, devices)
- Collaborators
- CW-Research and Management GmbH
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 13 Jan 2023 (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.
Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100
Detailed description
This is a single center, open-label, monocentric, multiple IV dose, phase I study to investigate the penetration of rifabutin into the lung after multiple intravenous administrations of BV100 (rifabutin for infusion) in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BV100 | Experimental | Drug: BV1007 doses of BV100 (q12h) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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:
- 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.
Key exclusion criteria (28 listed)
- As a result of the medical screening process, the study physician considered the subject unfit for the study.
- Pregnant or lactating women, or men with female partners, who are not willing to use contraception as defined in inclusion criterion #6.
- 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.
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 |
|---|---|---|
| BV100Also: Rifabutin for InfusionIntravenous infusion | Drug | BV100 |
Primary outcome
To assess plasma concentration of rifabutin in healthy participants
Time frame: 5 Days
Plasma concentration of rifabutin
To assess epithelial lining fluid concentration of rifabutin in healthy participants
Time frame: 5 days
Concentration of rifabutin in the epithelial lining fluid
To assess concentration of rifabutin in alveolar macrophages of healthy participants
Time frame: 5 days
Concentration of rifabutin in the alveolar macrophages
1 secondary outcome
Safety and Tolerability of multiple dose administration of BV100 in healthy participants
Time frame: 13 days
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 14 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Lisa Husband, MD study director
BioVersys SAS
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 BV100 in people with Bacterial Infections, run by BioVersys AG at 1 site in Austria.
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 14 inclusion and 28 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 14 Jan 2025. 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 Austria. 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?
To assess plasma concentration of rifabutin in healthy participants (time frame: 5 Days). The study lists 3 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 14 Jan 2025.