NCT05516225

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 2016

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2017

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

August 22, 2022

Last Update Submit

August 23, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Stool, saliva, and vaginal microbiome

    28 days

  • Serum cytokine levels

    28 days

Study Arms (4)

PBCLN-003, 1.8 g daily in 3 divided oral doses for 7 days

EXPERIMENTAL
Drug: PBCLN-003

PBCLN-003, 3.6 g daily in 3 divided oral doses for 7 days

EXPERIMENTAL
Drug: PBCLN-003

PBCLN-003, 9 g daily in 3 divided oral doses for 7 days

EXPERIMENTAL
Drug: PBCLN-003

PBCLN-003, 18 g daily in 3 divided oral doses for 7 days

EXPERIMENTAL
Drug: PBCLN-003

Interventions

PBCLN-003DRUG

Human Milk Oligosaccharide Concentrate

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

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WCCT Global, LLC

Cypress, California, 90630, United States

Location

Related Publications (1)

  • Jacobs JP, Lee ML, Rechtman DJ, Sun AK, Autran C, Niklas V. Human milk oligosaccharides modulate the intestinal microbiome of healthy adults. Sci Rep. 2023 Aug 31;13(1):14308. doi: 10.1038/s41598-023-41040-5.

    PMID: 37652940DERIVED

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2022

First Posted

August 25, 2022

Study Start

September 29, 2016

Primary Completion

February 13, 2017

Study Completion

February 13, 2017

Last Updated

August 25, 2022

Record last verified: 2022-08

Locations

US(1)