Healthy VolunteersPhase 1NCT05818306
A Phase Ia Safety and Tolerability Study of BL-001
A Phase 1 study testing BL-001 in people with Healthy Volunteers, run by Bloom Science at 1 site in Switzerland.
Trial summary
To investigate the safety and tolerability of BL-001 in healthy volunteers for 28 consecutive days. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BL-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Feb 2023to 2 Jun 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent: signed written informed consent before inclusion in the study
- Sex and Age: men/women, 18-55 years old inclusive
- Body Mass Index (BMI): 18.5-30 kg/m2 inclusive
- Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position
- Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
- Contraception and fertility (women only): women of child-bearing potential must be using at least one of the protocol defined and reliable methods of contraception
Who cannot join
- Electrocardiogram 12-leads (supine position): clinically significant abnormalities
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
- Bowel movements: on average ≥3 stools per day or <3 stools per week
- Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
- Allergy: ascertained or presumptive hypersensitivity to the formulation's ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
- Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, psychiatric or neurological diseases that may interfere with the aim of the study
- Gastrointestinal: evidence of acute or chronic gastrointestinal disorders
- Medications and probiotics: probiotics, nutraceuticals, and medications, including over the counter medications and herbal remedies for 2 weeks and antibiotics for 3 months before the start of the study. Hormonal contraceptives for women will be allowed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ia, Randomized, Parallel-group, Double-blind, Placebo-controlled, Single-center, Multiple Dose Safety and Tolerability Study of Ascending Doses of BL-001 Oral Capsules Administered for 28 Days to Healthy Volunteers
To investigate the safety and tolerability of BL-001 in healthy volunteers for 28 consecutive days.
Read the detailed description
This is a Phase 1a randomized, parallel-group, double-blind, placebo-controlled, single-center, multiple dose study to evaluate the safety and tolerability of BL-001.
- Conditions
- Healthy Volunteers
- Being tested
- BL-001, Placebo
- Keywords
- Bloom Science, Bloom, BL-001, Microbiome, LBP, Live Biological Product, Live Biotherapeutic Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL-001Drug
Live biological product BL-001
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort A Dose 1 | Experimental | Oral, daily administration of BL-001 Dose 1 or Placebo randomized 3:1 (BL-001: Placebo) Receives: Drug: BL-001; Drug: Placebo |
| Cohort B Dose 2 | Experimental | Oral, daily administration of BL-001 Dose 2 or Placebo randomized 3:1 (BL-001: Placebo) Receives: Drug: BL-001; Drug: Placebo |
| Cohort C Dose 3 | Experimental | Oral, daily administration of BL-001 Dose 3 or Placebo randomized 3:1 (BL-001: Placebo) Receives: Drug: BL-001; Drug: Placebo |
| Cohort D Dose 4 | Experimental | Oral, daily administration of BL-001 Dose 4 or Placebo randomized 3:1 (BL-001: Placebo) Receives: Drug: BL-001; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of BL-001
Safety and tolerability of BL-001 as measured by treatment-emergent adverse events
Measured: Treatment-emergent adverse events are reviewed from screening through Day 28
Secondary outcomes (4)
Intestinal engraftment
The intestinal engraftment of the microbiota with BL-001 component strains
Measured: Fecal samples are collected by the subjects at home from screening through Day 28
Intestinal microbiota changes
Changes in the intestinal microbiota, including microbial taxonomic and functional characterization as well as diversity metrics
Measured: Fecal samples are collected by the subjects at home from screening through Day 28
Metabolite changes in stool samples
Analysis of metabolite changes in stool samples
Measured: Fecal samples are collected by the subjects at home from screening through Day 28
Metabolite changes in plasma samples
Analysis of metabolite changes in plasma samples
Measured: Venous blood samples are collected by venipuncture from a forearm vein at visits starting at screening through Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start20 Feb 2023
- Primary completion19 May 2023
- Study completion2 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel-group, double-blind, placebo-controlled, single-center, multiple dose safety \& tolerability Phase Ia study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bloom Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paolo Baroldi, Study director, Bloom Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818306
- Sponsor's protocol ID
- BL-001-1001
- Status last verified
- Jun 2023
- First submitted
- 24 Mar 2023
- Last updated
- 27 Jun 2023
- 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 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia, Randomized, Parallel-group, Double-blind, Placebo-controlled, Single-center, Multiple Dose Safety and Tolerability Study of Ascending Doses of BL-001 Oral Capsules Administered for 28 Days to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05818306
- Acronym / sponsor ID
- BL-001-1001
- Conditions
- Healthy Volunteers
- Keywords
- Bloom Science, Bloom, BL-001, Microbiome, LBP, Live Biological Product, Live Biotherapeutic Product
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bloom ScienceIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 19 May 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 18 Apr 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.
To investigate the safety and tolerability of BL-001 in healthy volunteers for 28 consecutive days.
Detailed description
This is a Phase 1a randomized, parallel-group, double-blind, placebo-controlled, single-center, multiple dose study to evaluate the safety and tolerability of BL-001.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Randomized, parallel-group, double-blind, placebo-controlled, single-center, multiple dose safety \& tolerability Phase Ia study
| Arm | Type | Receives |
|---|---|---|
| Cohort A Dose 1 | Experimental | Drug: BL-001, Drug: PlaceboOral, daily administration of BL-001 Dose 1 or Placebo randomized 3:1 (BL-001: Placebo) |
| Cohort B Dose 2 | Experimental | Drug: BL-001, Drug: PlaceboOral, daily administration of BL-001 Dose 2 or Placebo randomized 3:1 (BL-001: Placebo) |
| Cohort C Dose 3 | Experimental | Drug: BL-001, Drug: PlaceboOral, daily administration of BL-001 Dose 3 or Placebo randomized 3:1 (BL-001: Placebo) |
| Cohort D Dose 4 | Experimental | Drug: BL-001, Drug: PlaceboOral, daily administration of BL-001 Dose 4 or Placebo randomized 3:1 (BL-001: Placebo) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Informed consent: signed written informed consent before inclusion in the study
- Sex and Age: men/women, 18-55 years old inclusive
- Body Mass Index (BMI): 18.5-30 kg/m2 inclusive
- Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position
- Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
Key exclusion criteria (8 listed)
- Electrocardiogram 12-leads (supine position): clinically significant abnormalities
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
- Bowel movements: on average ≥3 stools per day or <3 stools per week
- Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
- Allergy: ascertained or presumptive hypersensitivity to the formulation's ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
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 |
|---|---|---|
| BL-001Live biological product BL-001 | Drug | Cohort A Dose 1, Cohort B Dose 2, Cohort C Dose 3, Cohort D Dose 4 |
| PlaceboPlacebo | Drug | Cohort A Dose 1, Cohort B Dose 2, Cohort C Dose 3, Cohort D Dose 4 |
Primary outcome
Safety and tolerability of BL-001
Time frame: Treatment-emergent adverse events are reviewed from screening through Day 28
Safety and tolerability of BL-001 as measured by treatment-emergent adverse events
4 secondary outcomes
Intestinal engraftment
Time frame: Fecal samples are collected by the subjects at home from screening through Day 28
Intestinal microbiota changes
Time frame: Fecal samples are collected by the subjects at home from screening through Day 28
Metabolite changes in stool samples
Time frame: Fecal samples are collected by the subjects at home from screening through Day 28
Metabolite changes in plasma samples
Time frame: Venous blood samples are collected by venipuncture from a forearm vein at visits starting at screening through Day 28
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 27 Jun 2023.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Paolo Baroldi study director
Bloom Science
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 BL-001 in people with Healthy Volunteers, run by Bloom Science at 1 site in Switzerland.
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 6 inclusion and 8 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 27 Jun 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 Switzerland. 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?
Safety and tolerability of BL-001 (time frame: Treatment-emergent adverse events are reviewed from screening through Day 28). 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 27 Jun 2023.