A Phase Ia Safety and Tolerability Study of BL-001

Study Overview
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Brief Summary
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To investigate the safety and tolerability of BL-001 in healthy volunteers for 28 consecutive days.

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: BL-001
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion criteria 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 Key Exclusion criteria 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, parallel-group, double-blind, placebo-controlled, single-center, multiple dose safety & tolerability Phase Ia study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A Dose 1<br>Oral, daily administration of BL-001 Dose 1 or Placebo randomized 3:1 (BL-001: Placebo) | Drug: BL-001<br>* Live biological product BL-001<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: Cohort B Dose 2<br>Oral, daily administration of BL-001 Dose 2 or Placebo randomized 3:1 (BL-001: Placebo) | Drug: BL-001<br>* Live biological product BL-001<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: Cohort C Dose 3<br>Oral, daily administration of BL-001 Dose 3 or Placebo randomized 3:1 (BL-001: Placebo) | Drug: BL-001<br>* Live biological product BL-001<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: Cohort D Dose 4<br>Oral, daily administration of BL-001 Dose 4 or Placebo randomized 3:1 (BL-001: Placebo) | Drug: BL-001<br>* Live biological product BL-001<br>Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of BL-001 | Safety and tolerability of BL-001 as measured by treatment-emergent adverse events | Treatment-emergent adverse events are reviewed from screening through Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal engraftment | The intestinal engraftment of the microbiota with BL-001 component strains | 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 | 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 | 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 | Venous blood samples are collected by venipuncture from a forearm vein at visits starting at screening through Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bloom Science, Bloom, BL-001, Microbiome, LBP, Live Biological Product, Live Biotherapeutic Product