A Phase Ia Safety and Tolerability Study of BL-001

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05818306
• Other study ID #: BL-001-1001
• Status: Completed
• Phase: Phase 1
• Start date: February 20, 2023
• Est. completion date: June 2, 2023

Study information

• Verified date: June 2023
• Source: Bloom Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2, 2023
• Est. primary completion date: May 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• BL-001
Live biological product BL-001
• Placebo
Placebo

Locations

Country	Name	City	State
Switzerland	CROSS Research S.A.	Arzo	Canton Ticino

Sponsors (1)

Lead Sponsor	Collaborator
Bloom Science

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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