Healthy Volunteers
Conditions
Keywords
Bloom Science, Bloom, BL-001, Microbiome, LBP, Live Biological Product, Live Biotherapeutic Product
Brief summary
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.
Interventions
DRUGBL-001
Live biological product BL-001
DRUGPlacebo
Placebo
Sponsors
Bloom Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Both the Investigator and the subjects are not aware of the treatment administered.
Intervention model description
Randomized, parallel-group, double-blind, placebo-controlled, single-center, multiple dose safety & tolerability Phase Ia study
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion criteria 1. Informed consent: signed written informed consent before inclusion in the study 2. Sex and Age: men/women, 18-55 years old inclusive 3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive 4. 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 5. 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 6. 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 Key
Exclusion criteria
1. Electrocardiogram 12-leads (supine position): clinically significant abnormalities 2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study 3. Bowel movements: on average ≥3 stools per day or \<3 stools per week 4. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness 5. 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 6. 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 7. Gastrointestinal: evidence of acute or chronic gastrointestinal disorders 8. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of BL-001 | Treatment-emergent adverse events are reviewed from screening through Day 28 | Safety and tolerability of BL-001 as measured by treatment-emergent adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intestinal engraftment | Fecal samples are collected by the subjects at home from screening through Day 28 | The intestinal engraftment of the microbiota with BL-001 component strains |
| Intestinal microbiota changes | Fecal samples are collected by the subjects at home from screening through Day 28 | Changes in the intestinal microbiota, including microbial taxonomic and functional characterization as well as diversity metrics |
| Metabolite changes in stool samples | Fecal samples are collected by the subjects at home from screening through Day 28 | Analysis of metabolite changes in stool samples |
| Metabolite changes in plasma samples | Venous blood samples are collected by venipuncture from a forearm vein at visits starting at screening through Day 28 | Analysis of metabolite changes in plasma samples |
Countries
Switzerland
Outcome results
None listed