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A Phase Ia Safety and Tolerability Study of BL-001

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05818306
Recruitment Status : Completed
First Posted : April 18, 2023
Last Update Posted : June 27, 2023
Sponsor:
Information provided by (Responsible Party):
Bloom Science

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: BL-001 Drug: Placebo Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, parallel-group, double-blind, placebo-controlled, single-center, multiple dose safety & tolerability Phase Ia study
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Both the Investigator and the subjects are not aware of the treatment administered.
Primary Purpose: Health Services Research
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
Actual Study Start Date : February 20, 2023
Actual Primary Completion Date : May 19, 2023
Actual Study Completion Date : June 2, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort A Dose 1
Oral, daily administration of BL-001 Dose 1 or Placebo randomized 3:1 (BL-001: Placebo)
 Drug: BL-001
Live biological product BL-001

Drug: Placebo
Placebo
Experimental: Cohort B Dose 2
Oral, daily administration of BL-001 Dose 2 or Placebo randomized 3:1 (BL-001: Placebo)
 Drug: BL-001
Live biological product BL-001

Drug: Placebo
Placebo
Experimental: Cohort C Dose 3
Oral, daily administration of BL-001 Dose 3 or Placebo randomized 3:1 (BL-001: Placebo)
 Drug: BL-001
Live biological product BL-001

Drug: Placebo
Placebo
Experimental: Cohort D Dose 4
Oral, daily administration of BL-001 Dose 4 or Placebo randomized 3:1 (BL-001: Placebo)
 Drug: BL-001
Live biological product BL-001

Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Intestinal engraftment [ Time Frame: 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

  2. Intestinal microbiota changes [ Time Frame: 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

  3. Metabolite changes in stool samples [ Time Frame: Fecal samples are collected by the subjects at home from screening through Day 28 ]
    Analysis of metabolite changes in stool samples

  4. 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 ]
    Analysis of metabolite changes in plasma samples


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05818306


Locations
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Switzerland
CROSS Research S.A.
Arzo, Canton Ticino, Switzerland, CH-6864
Sponsors and Collaborators
Bloom Science
Investigators
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Study Director: Paolo Baroldi Bloom Science
More Information
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Responsible Party: Bloom Science
ClinicalTrials.gov Identifier: NCT05818306    
Other Study ID Numbers: BL-001-1001
First Posted: April 18, 2023    Key Record Dates
Last Update Posted: June 27, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Bloom Science:
Bloom Science
Bloom
BL-001
Microbiome
 LBP
Live Biological Product
Live Biotherapeutic Product