A Phase Ia Safety and Tolerability Study of BL-001

Bloom Science

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: BL-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT05818306

BL-001-1001

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 4 patient groups

Cohort A Dose 1

Experimental group

Description:

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

Treatment:

Drug: BL-001

Drug: Placebo

Cohort B Dose 2

Experimental group

Description:

Oral, daily administration of BL-001 Dose 2 or Placebo randomized 3:1 (BL-001: Placebo)

Treatment:

Drug: BL-001

Drug: Placebo

Cohort C Dose 3

Experimental group

Description:

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

Treatment:

Drug: BL-001

Drug: Placebo

Cohort D Dose 4

Experimental group

Description:

Oral, daily administration of BL-001 Dose 4 or Placebo randomized 3:1 (BL-001: Placebo)

Treatment:

Drug: BL-001

Drug: Placebo