Safety Study of Human Milk Oligosaccharides in Healthy Adults

Phase 1 Completed 32 enrolled Prolacta Bioscience

Non-randomizedSequentialOpen-labelTreatment

Summary

First-in-human phase 1 study conducted in healthy adult male and female volunteers to determine the safety and tolerability of increasing doses of PBCLN-003, which are concentrated human milk oligosaccharides (HMO).

Timeline

Start: 2016-09-29
Primary completion: 2017-02-13
Completion: 2017-02-13

Publications

Jacobs JP, Lee ML, Rechtman DJ, Sun AK, Autran C, Niklas V. Human milk oligosaccharides modulate the intestinal microbiome of healthy adults. Sci Rep. 2023 Aug 31;13(1):14308. doi: 10.1038/s41598-023-41040-5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PBCLN-003	Other / unclassified	1.8 g	Oral
Subject	PBCLN-003	Other / unclassified	3.6 g	Oral
Subject	PBCLN-003	Other / unclassified	9 g	Oral
Subject	PBCLN-003	Other / unclassified	18 g	Oral

Indications

No indication recorded.