A Phase 1 interventional study of BL-001 and Placebo in Healthy Volunteers, sponsored by Bloom Science. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-27.
Sponsored by Bloom Science · Phase 1, Interventional, and Health services research
To investigate the safety and tolerability of BL-001 in healthy volunteers for 28 consecutive days.
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.
This is the only study on the registry with Bloom Science as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Key Inclusion criteria
Key Exclusion criteria
Oral, daily administration of BL-001 Dose 1 or Placebo randomized 3:1 (BL-001: Placebo)
Drug: BL-001 · Drug: Placebo
Oral, daily administration of BL-001 Dose 2 or Placebo randomized 3:1 (BL-001: Placebo)
Drug: BL-001 · Drug: Placebo
Oral, daily administration of BL-001 Dose 3 or Placebo randomized 3:1 (BL-001: Placebo)
Drug: BL-001 · Drug: Placebo
Oral, daily administration of BL-001 Dose 4 or Placebo randomized 3:1 (BL-001: Placebo)
Drug: BL-001 · Drug: Placebo
Live biological product BL-001
Placebo
Safety and tolerability of BL-001
Safety and tolerability of BL-001 as measured by treatment-emergent adverse events
Time frame: Treatment-emergent adverse events are reviewed from screening through Day 28
Intestinal engraftment
The intestinal engraftment of the microbiota with BL-001 component strains
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Venous blood samples are collected by venipuncture from a forearm vein at visits starting at screening through Day 28
Plan to share: No
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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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