Healthy SubjectsPhase 1NCT04636983
Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of BV100 in Male Subjects
A Phase 1 study testing BV100 in people with Healthy Subjects, run by BioVersys SAS at 1 site in Germany.
Trial summary
This is a Phase 1, single-centre, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single intravenous ascending doses of BV100 to healthy male subjects. 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 Subjects
- 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
- 54 participants
- Where
- 1 siteGermany
- Study dates
- 9 Nov 2020to 20 Jan 2022
- 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 study.
- 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 2014 ) guidance and includes the following methods: implants, injectables, hormonal intrauterine device, combined hormonal contraceptives, sexual abstinence and vasectomized sexual partner.
- refrain from donating sperm.
- Prior to any clinical study specific procedure the subject provided written informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Subjects must be able to read, write, and fully understand the German language.
- 7. Prior to any clinical study specific procedure the subject provided written informed consent as described in Appendix 3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Subjects must be able to read, write, and fully understand the German language.
Who cannot join
- History of clinically relevant disease of any organ system that may interfere with the objectives of the study 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 study.
- 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 > 200 ms, or QRS duration > 110 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) < 90 mL/min/1.73m2 as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula. In case of a borderline result between ≥ 80 and < 90 mL/min, Cystatin C will be determined in addition, and the subject will only be included if the Cystatin C value is below the upper limit of normal (ULN).
- 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.
- Screening values other than AST, ALT, ALP, creatinine, for haematology, biochemistry, 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.
- 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 study 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 the first admission to the clinical unit.
- Administration of live vaccine(s) within 1 month prior to screening, or plans to receive such vaccines during the study.
- Subjects 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).
- Exposure to more than 4 new chemical entities in the last 12 months before the first dosing day in this study.
- 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.
- Subjects 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 ½ pint [285 mL] of beer or lager, one glass [125 mL] of wine, or 30 mL of 40% of 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 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 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.
- 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.
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 Single Intravenous Doses to Healthy Male Subjects
This is a Phase 1, single-centre, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single intravenous ascending doses of BV100 to healthy male subjects.
Read the detailed description
The purpose of this First in human study is to evaluate the safety, tolerability, and pharmacokinetics of single intravenous ascending doses of BV100 to healthy subjects. Participants will either receive one single intravenous infusion of BV100 or placebo (physiological saline 0.9% w/v).
- Conditions
- Healthy Subjects
- 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 IV
PlaceboDrug
Saline
| Study group | Role | What they receive |
|---|---|---|
| BV100 | Experimental | BV100 intravenous infusion Receives: Drug: BV100 |
| Placebo | Placebo comparator | Saline intravenous infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the safety and tolerability of single intravenous ascending doses of BV100 assessed by the nature, occurrence, and severity of treatment-emergent adverse events
Safety and tolerability
Measured: 10 Days
Secondary outcomes (2)
To characterize the single dose pharmacokinetic profile of rifabutin: Area under the plasma concentration versus time curve (AUC)
Pharmacokinetics
Measured: 120 hours
To characterize the single dose pharmacokinetic profile of rifabutin: Peak Plasma Concentration (Cmax)
Pharmacokinetics
Measured: 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start9 Nov 2020
- Primary completion12 Dec 2021
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioVersys SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Denis Strugala, MD, Principal investigator, Nuvisan GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636983
- Sponsor's protocol ID
- BV100-01
- Status last verified
- Oct 2021
- First submitted
- 10 Nov 2020
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Single Intravenous Doses to Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04636983
- Acronym / sponsor ID
- BV100-01
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- BioVersys SASIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 19 Nov 2020 (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.
This is a Phase 1, single-centre, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single intravenous ascending doses of BV100 to healthy male subjects.
Detailed description
The purpose of this First in human study is to evaluate the safety, tolerability, and pharmacokinetics of single intravenous ascending doses of BV100 to healthy subjects. Participants will either receive one single intravenous infusion of BV100 or placebo (physiological saline 0.9% w/v).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BV100 | Experimental | Drug: BV100BV100 intravenous infusion |
| Placebo | Placebo comparator | Drug: PlaceboSaline intravenous infusion |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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 study.
Key exclusion criteria (28 listed)
- History of clinically relevant disease of any organ system that may interfere with the objectives of the study 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 study.
- 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 > 200 ms, or QRS duration > 110 ms.
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 |
|---|---|---|
| BV100Rifabutin IV | Drug | BV100 |
| PlaceboSaline | Drug | Placebo |
Primary outcome
To investigate the safety and tolerability of single intravenous ascending doses of BV100 assessed by the nature, occurrence, and severity of treatment-emergent adverse events
Time frame: 10 Days
Safety and tolerability
2 secondary outcomes
To characterize the single dose pharmacokinetic profile of rifabutin: Area under the plasma concentration versus time curve (AUC)
Time frame: 120 hours
To characterize the single dose pharmacokinetic profile of rifabutin: Peak Plasma Concentration (Cmax)
Time frame: 120 hours
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 8 Feb 2022.
- Derived from this study: PubMed 41770249Kemmer 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.
- 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.
Denis Strugala, MD principal investigator
Nuvisan GmbH
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 Healthy Subjects, 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 8 Feb 2022. 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 single intravenous ascending doses of BV100 assessed by the nature, occurrence, and severity of treatment-emergent adverse events (time frame: 10 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 NCT04636983, 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 8 Feb 2022.