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Healthy VolunteersPhase 1NCT05087069

Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of BV100 in Healthy Male Subjects

A Phase 1 study testing BV100 in people with Healthy Volunteers, run by BioVersys SAS at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Safety and tolerability and Pharmacokinetics of multiple doses of BV100 in healthy volunteers Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
BV100
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteGermany
Study dates
8 Oct 2021to 12 Jan 2023
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
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subject must be 18 to 55 years of age inclusive at the time of signing the informed consent.
  • Subjects who are healthy as determined by the Investigator based on medical evaluation including medical history, physical and neurological examination, vital signs, ECG, and clinical laboratory tests at screening and on Day -1.
  • Subjects are able to have an intravenous line placed.
  • Body weight of at least 50 kg and BMI within the range of 19 to 30 kg/m2 (inclusive) at screening examination.
  • Male subjects will be included in the trial.
  • Subjects must agree to the following from the time of the first dose until 3 months after the follow-up visit:
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  • use two acceptable methods of birth control with a female partner of child bearing potential (barrier method combined with an additional highly effective contraceptive method). Barrier methods of contraception include condom or occlusive cap (diaphragm or cervical/vault caps). Highly effective contraception is defined in accordance with the Clinical Trial Facilitation Group (CTFG 2020 ) guidance and includes the following methods: hormonal implants, injectables, hormonal intrauterine device, combined hormonal contraceptives, sexual abstinence and vasectomised sexual partner. For details refer to Appendix 2.
  • refrain from donating sperm.
  • Prior to any clinical trial specific procedure the subject provided written informed consent. Subjects must be able to read, write, and fully understand the German language.
  • The subject is a non-smoker, former smoker (<10 pack year smoking history) or former user of nicotine containing products or stable non-smoker for at least 3 months before the first study drug administration. Subjects should also have abstained from use of e-cigarettes for at least 3 months before first study drug administration.

Who cannot join

  • History of clinically relevant disease of any organ system that may interfere with the objectives of the trial or provide a risk to the health of the subject.
  • 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 hospitalisation 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 trial.
  • History of antibiotic associated diarrhoea within the last year.
  • History of epilepsy, other neurological disorders, or neuropsychiatric conditions.
  • Subjects 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 > 115 ms.
  • Supine systolic blood pressure > 140 mmHg or < 90 mmHg or diastolic blood pressure > 90 mmHg or < 50 mmHg 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 or < 50 beats per minute at Screening or Day 1 prior to dosing.
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  • Glomerular Filtration Rate (GFR) < 80 mL/min/1.73m2 as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula.
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and creatinine, above the upper limit of normal (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.
  • Screening values other than AST, ALT, ALP, creatinine, for haematology, clinical chemistry, or urinalysis must not exceed the reference range. Minor deviations from normal are allowed, if they are not clinically significant.
  • History of symptomatic, chronic or recurrent infection (e.g. nausea, vomiting, diarrhoea, 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.
  • Evidence of COVID-19 signs or symptoms, exposure to infected person or confirmed COVID-19 infection within the last 2 weeks.
  • Subjects who have received any prescribed systemic or topical medication within 4 weeks of the dose administration or within 5 times the half-life, whichever is longer, except for the occasional use of paracetamol (up to 2 g/day).
  • Subjects who have used any non-prescribed systemic or topical medication (including dietary supplements, natural and herbal remedies) or megadose vitamins (i.e. 20 to 600 times the recommended daily supplement dose) within 7 days of the dose administration, unless in the opinion of the Investigator the medication will not interfere with the trial procedures or compromise safety.
  • Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration.
  • Regular use of any inducer of metabolism (e.g., barbiturates, rifampin) in the 3 months prior to admission to the clinical unit.
  • Administration of live, attenuated, replication-competent vaccine(s), including vector-based or mRNA COVID-19 vaccine(s), within 1 month prior to screening or plans to receive such vaccines during the trial.
  • Subjects who have participated in a clinical trial involving administration of an investigational drug (new chemical entity) within the following time period prior to the dosing day in the current trial: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Exposure to more than 4 new chemical entities in the last 12 months before the first dosing day in this trial.
  • 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 pre-study drug/alcohol screen/SARS-CoV-2 test. Higher than low-risk alcohol consumption i.e., consumption of an average weekly alcohol intake of 14 units/week for men (daily dose of 24 g, weekly dose of 168 g). One unit (12 g) corresponds to 0.3 L of beer/day or 0.12 L of wine/day or 1 glass (at 2 cL) of spirits/day.
  • 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 study treatment administration.
  • Any use of drugs-of-abuse or alcohol abuse within 2 years prior to the first admission to the clinical unit.
  • Subjects who are unable to refrain from the consumption of Seville oranges, grapefruit or grapefruit juice and /or pomelos, exotic citrus fruits, grapefruit hybrids, starfruit or fruit juices from 1 day prior to the first dose of Study Drug on Day 1, until completion of the last PK blood sample time point.
  • 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 trial.
  • Any other conditions or factors which in the opinion of the Investigator may interfere with trial 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.
  • Inability to refrain from using soft contact lenses starting from administration of study treatment until follow-up visit.
  • Subjects who are study site employees or immediate family members of the study site or Sponsor employee.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Nuvisan GmbH

    Neu-Ulm, 89231

Other trials in Germany

About this study

Official title: A Phase I, Single-centre, Double-blind, Randomised, Placebo-controlled Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of BV100 Administered as Multiple Intravenous Doses to Healthy Male Subjects

Safety and tolerability and Pharmacokinetics of multiple doses of BV100 in healthy volunteers

Read the detailed description

The study will investigate the safety and tolerability of increasing multiple intravenous doses of BV100 by assessing the Incidence of treatment-emergent adverse events (TEAEs). In addition the goal is to characterize the multiple dose pharmacokinetic profiles of rifabutin in plasma.

Being tested
BV100, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BV100Drug

    Rifabutin for Infusion

  • PlaceboDrug

    Saline intravenous infusion

Study groups in NCT05087069
Study groupRoleWhat they receive
BV100ExperimentalBV100 intravenous infusion
Receives: Drug: BV100
PlaceboPlacebo comparatorSaline intravenous infusion
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To investigate the safety and tolerability of increasing multiple intravenous doses of BV100

    Incidence of treatment-emergent adverse events (TEAEs)

    Measured: 21 Days

Secondary outcomes (2)

  1. To characterize the pharmacokinetic profile of rifabutin

    Area under the plasma concentration versus time curve (AUC)

    Measured: 11 Days

  2. To characterize the plasma concentration of rifabutin

    Peak Plasma Concentration (Cmax)

    Measured: 11 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2021
  2. Study start8 Oct 2021
  3. Primary completion8 Apr 2022
  4. Study completion12 Jan 2023

Resources

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
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05087069
Sponsor's protocol ID
BV100-02
Status last verified
Jun 2022
First submitted
9 Oct 2021
Last updated
17 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kemmer C, Hirsch M, Reh C, Davila M, Jung F, Husband L, Dale GE. Single-ascending and multiple-ascending dose study of the pharmacokinetics, safety, and tolerability of BV100 (rifabutin for infusion) in healthy volunteers. Antimicrob Agents Chemother. 2026 Apr;70(4):e0158225. doi: 10.1128/aac.01582-25. Epub 2026 Mar 2.

    PubMed 41770249

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BV100 in people with Healthy Volunteers, run by BioVersys SAS at 1 site in Germany.

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 10 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 17 Jan 2023. 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 Germany. 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. Some participants in this study may receive a placebo. 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 investigate the safety and tolerability of increasing multiple intravenous doses of BV100 (time frame: 21 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05087069, which also lists 1 linked publication.

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 17 Jan 2023.

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