A Phase Ia Safety and Tolerability Study of BL-001

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: BL-001

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Paolo Baroldi, Chief Medical Officer; Phone Number: +1.619.592.5268; Email: info@bloomscience.com

Study Locations

• Switzerland
  • Canton Ticino
    • Arzo, Canton Ticino, Switzerland, CH-6864
      • CROSS Research S.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / 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: Placebo; Placebo; Drug: BL-001; Live biological product BL-001
Experimental: Cohort B Dose 2; Oral, daily administration of BL-001 Dose 2 or Placebo randomized 3:1 (BL-001: Placebo)	Drug: Placebo; Placebo; Drug: BL-001; Live biological product BL-001
Experimental: Cohort C Dose 3; Oral, daily administration of BL-001 Dose 3 or Placebo randomized 3:1 (BL-001: Placebo)	Drug: Placebo; Placebo; Drug: BL-001; Live biological product BL-001
Experimental: Cohort D Dose 4; Oral, daily administration of BL-001 Dose 4 or Placebo randomized 3:1 (BL-001: Placebo)	Drug: Placebo; Placebo; Drug: BL-001; Live biological product BL-001

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bloom Science
• Investigators: Study Director: Paolo Baroldi, Bloom Science

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Actual): May 19, 2023
• Study Completion (Actual): June 2, 2023

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Microbiome; LBP; Live Biotherapeutic Product; Bloom Science; Bloom; BL-001; Live Biological Product
• Other Study ID Numbers: BL-001-1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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