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OpenTrials
Completed

NCT Number: NCT05516225

Safety Study of Human Milk Oligosaccharides in Healthy Adults

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).

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

WCCT Global, LLC

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index (BMI) between 18.5 and 24.9 kg/m2
  • Age between 18 and 50 years old
  • No diagnosed medical conditions
  • No significant change to diet in the 2 weeks prior to enrollment
  • Agreement to use contraception for female subjects

Exclusion criteria

  • Lactose intolerance
  • Pregnancy
  • Lactation
  • Enrollment in another clinical study

Treatment and study plan

PBCLN-003

Drug

Human Milk Oligosaccharide Concentrate

Primary outcomes

  1. Number of Adverse Events

    Time frame: 28 days

    Adverse events include those reported by questionnaire or detected as an abnormality on physical examination, laboratory testing (hematology, biochemistry, urinalysis), and 12-lead electrocardiogram.

Secondary outcomes

  1. Stool, saliva, and vaginal microbiome

    Time frame: 28 days

    16S ribosomal RNA gene sequencing and shotgun metagenomics will be performed to detect relative abundances of bacteria at the level of 97% operational taxonomic units. Alpha diversity will be measured using the Shannon index.

  2. Serum cytokine levels

    Time frame: 28 days

    IL2, IL4, IL5, IL6, IL10, IL12, TNFα, IFNγ, and TGFβ measured by ELISA

Sponsors and collaborators

Lead sponsor

Prolacta Bioscience

Industry

Registry information

Official study title

Phase 1 Safety Study of Human Milk Oligosaccharide Concentrate PBCLN-003 in Healthy Adult Volunteers

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 25, 2022
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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