Safety Study of Human Milk Oligosaccharides in Healthy Adults

Prolacta Bioscience32 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

PBCLN-003DRUG

Human Milk Oligosaccharide Concentrate

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

WCCT Global, LLC

Cypress, California, United States

Outcomes

Primary Outcomes

Number of Adverse Events

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

Time frame: 28 days

Secondary Outcomes

Stool, saliva, and vaginal microbiome

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.

Time frame: 28 days

Serum cytokine levels

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

Time frame: 28 days

Data from ClinicalTrials.gov

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