NCT05516225 is a Phase 1 clinical trial of PBCLN-003 in Healthy, sponsored by Prolacta Bioscience.

Who is sponsoring NCT05516225?

NCT05516225 is sponsored by Prolacta Bioscience.

What drugs are being tested in NCT05516225?

Interventions in NCT05516225: PBCLN-003.

Is NCT05516225 still recruiting?

NCT05516225 is currently completed. Last updated 25 August 2022.

Last reviewed 2022-08-25 · How we verify

NCT05516225

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety Study of Human Milk Oligosaccharides in Healthy Adults

Completed Phase 1 Last updated 25 August 2022

What this trial tests

Phase 1 trial testing PBCLN-003 in Healthy in 32 participants. Completed in 13 February 2017.

Timeline

29 September 2016

Primary endpoint
13 February 2017

13 February 2017

Quick facts

Lead sponsor	Prolacta Bioscience
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	29 September 2016
Primary completion	13 February 2017
Estimated completion	13 February 2017
Sites	1 location across United States

Drugs / interventions tested

PBCLN-003 — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Prolacta Bioscience — full company profile →

Who can join

Adults 18 to 50, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Human milk oligosaccharides modulate the intestinal microbiome of healthy adults.
Jacobs JP, Lee ML, Rechtman DJ, Sun AK, et al · · 2023 · cited 27× · PMID 37652940 · DOI 10.1038/s41598-023-41040-5

Verify or expand the search:

Other trials of PBCLN-003

Trials testing the same drug.

NCT03793686 — A Study of Safety of PBCLN-003 Following Antibiotic Therapy in Subjects With C.Difficile-associated Diarrhea · Phase 1 · terminated

Other recruiting trials for Healthy

Currently open trials in the same condition.

NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting

Other Prolacta Bioscience trials

Trials by the same sponsor.

NCT06102213 — Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogenei · Phase 2 · terminated
NCT05141903 — Dietary Supplement With and Without a Probiotic and/or Antibiotic · completed
NCT04413994 — Exclusive Human-milk in Preterm NEOnates and Early VASCular Aging Risk Factors (NEOVASC) · NA · recruiting
NCT04433208 — Dietary Supplement With and Without a Probiotic · NA · completed
NCT03793686 — A Study of Safety of PBCLN-003 Following Antibiotic Therapy in Subjects With C.Difficile-associated Diarrhea · Phase 1 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05516225 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Prolacta Bioscience
Last refreshed: 25 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05516225.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing