A Phase Ia Safety and Tolerability Study of BL-001

NCT05818306 | Completed Phase 1

• 1 other identifier: BL-001-1001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Bloom Science; Bloom; BL-001; Microbiome; LBP; Live Biological Product; Live Biotherapeutic Product

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Intestinal engraftment

  Fecal samples are collected by the subjects at home from screening through Day 28

• Intestinal microbiota changes

  Fecal samples are collected by the subjects at home from screening through Day 28

• Metabolite changes in stool samples

  Fecal samples are collected by the subjects at home from screening through Day 28

• Metabolite changes in plasma samples

  Venous blood samples are collected by venipuncture from a forearm vein at visits starting at screening through Day 28

Study Arms (4)

Cohort A Dose 1

EXPERIMENTAL

Oral, daily administration of BL-001 Dose 1 or Placebo randomized 3:1 (BL-001: Placebo)

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)

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)

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)

Drug: BL-001; Drug: Placebo

Interventions

BL-001 DRUG

Live biological product BL-001

Cohort A Dose 1; Cohort B Dose 2; Cohort C Dose 3; Cohort D Dose 4

Placebo DRUG

Placebo

Cohort A Dose 1; Cohort B Dose 2; Cohort C Dose 3; Cohort D Dose 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bloom Science: lead

Study Sites (1)

CROSS Research S.A.

Arzo, Canton Ticino, CH-6864, Switzerland

Location

Study Officials

• Paolo Baroldi

  Bloom Science

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Both the Investigator and the subjects are not aware of the treatment administered.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, parallel-group, double-blind, placebo-controlled, single-center, multiple dose safety \& tolerability Phase Ia study

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 18, 2023
• Study Start: February 20, 2023
• Primary Completion: May 19, 2023
• Study Completion: June 2, 2023
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)