A Phase Ia Safety and Tolerability Study of BL-001

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: BL-001; Drug: Placebo

• Registration Number: NCT05818306
• Lead Sponsor: Bloom Science

Brief Summary

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

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 Timeline

• Study Start: 2023-02-20
• Study First Submitted: 2023-03-24
• Study First Submitted QC: 2023-04-17
• Study First Posted: 2023-04-18
• Primary Completion: 2023-05-19
• Status Verified: 2023-06
• Study Completion: 2023-06-02
• Last Update Submitted: 2023-06-26
• Last Update Posted: 2023-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort B Dose 2	BL-001	Oral, daily administration of BL-001 Dose 2 or Placebo randomized 3:1 (BL-001: Placebo)
Cohort B Dose 2	Placebo	Oral, daily administration of BL-001 Dose 2 or Placebo randomized 3:1 (BL-001: Placebo)
Cohort D Dose 4	BL-001	Oral, daily administration of BL-001 Dose 4 or Placebo randomized 3:1 (BL-001: Placebo)
Cohort A Dose 1	Placebo	Oral, daily administration of BL-001 Dose 1 or Placebo randomized 3:1 (BL-001: Placebo)
Cohort C Dose 3	BL-001	Oral, daily administration of BL-001 Dose 3 or Placebo randomized 3:1 (BL-001: Placebo)
Cohort C Dose 3	Placebo	Oral, daily administration of BL-001 Dose 3 or Placebo randomized 3:1 (BL-001: Placebo)
Cohort D Dose 4	Placebo	Oral, daily administration of BL-001 Dose 4 or Placebo randomized 3:1 (BL-001: Placebo)
Cohort A Dose 1	BL-001	Oral, daily administration of BL-001 Dose 1 or Placebo randomized 3:1 (BL-001: Placebo)

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of BL-001	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

Name	Time	Method
Intestinal engraftment	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
Intestinal microbiota changes	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
Metabolite changes in stool samples	Fecal samples are collected by the subjects at home from screening through Day 28	Analysis of metabolite changes in stool samples
Metabolite changes in plasma samples	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

Trial Locations

Locations (1)

CROSS Research S.A.; 🇨🇭 Arzo, Canton Ticino, Switzerland