Safety Study of Human Milk Oligosaccharides in Healthy Adults

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PBCLN-003

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • WCCT Global, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PBCLN-003, 1.8 g daily in 3 divided oral doses for 7 days	Drug: PBCLN-003; Human Milk Oligosaccharide Concentrate
Experimental: PBCLN-003, 3.6 g daily in 3 divided oral doses for 7 days	Drug: PBCLN-003; Human Milk Oligosaccharide Concentrate
Experimental: PBCLN-003, 9 g daily in 3 divided oral doses for 7 days	Drug: PBCLN-003; Human Milk Oligosaccharide Concentrate
Experimental: PBCLN-003, 18 g daily in 3 divided oral doses for 7 days	Drug: PBCLN-003; Human Milk Oligosaccharide Concentrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days
Serum cytokine levels	IL2, IL4, IL5, IL6, IL10, IL12, TNFα, IFNγ, and TGFβ measured by ELISA	28 days

Collaborators and Investigators

• Sponsor: Prolacta Bioscience

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2016
• Primary Completion (Actual): February 13, 2017
• Study Completion (Actual): February 13, 2017

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 16-CLN-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No