MedTrace Logo

Safety Study of Human Milk Oligosaccharides in Healthy Adults

NCT05516225 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-08-25

No results posted yet for this study

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).

Conditions

  • Healthy

Interventions

DRUG

PBCLN-003

Human Milk Oligosaccharide Concentrate

Sponsors & Collaborators

  • Prolacta Bioscience

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05516225 on ClinicalTrials.gov