Safety Study of Human Milk Oligosaccharides in Healthy Adults

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PBCLN-003

• Registration Number: NCT05516225
• Lead Sponsor: Prolacta Bioscience

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-29
• Primary Completion: 2017-02-13
• Study Completion: 2017-02-13
• Status Verified: 2022-08
• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-08-23
• Last Update Submitted: 2022-08-23
• Study First Posted: 2022-08-25
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
PBCLN-003, 18 g daily in 3 divided oral doses for 7 days	PBCLN-003	-
PBCLN-003, 1.8 g daily in 3 divided oral doses for 7 days	PBCLN-003	-
PBCLN-003, 3.6 g daily in 3 divided oral doses for 7 days	PBCLN-003	-
PBCLN-003, 9 g daily in 3 divided oral doses for 7 days	PBCLN-003	-

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	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 Outcome Measures

Name	Time	Method
Stool, saliva, and vaginal microbiome	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.
Serum cytokine levels	28 days	IL2, IL4, IL5, IL6, IL10, IL12, TNFα, IFNγ, and TGFβ measured by ELISA

Trial Locations

Locations (1)

WCCT Global, LLC; 🇺🇸 Cypress, California, United States