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NCT05516225 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Human Milk Oligosaccharides in Healthy Adults
A Phase 1 study, sponsored by Prolacta Bioscience.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT05516225: Completed Phase 1 study, sponsored by Prolacta Bioscience.
NCT05516225 is a Phase 1 study that has completed, run by Prolacta Bioscience. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05516225, a Phase 1 study, has completed, sponsored by Prolacta Bioscience.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study 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).
Primary Outcome
Adverse events include those reported by questionnaire or detected as an abnormality on physical examination, laboratory testing (hematology, biochemistry, urinalysis), and 12-lead electrocardiogram.
Interventions
- DRUG PBCLN-003
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2016-09-29 |
| Est. Completion | 2017-02-13 |
| Phase | Phase 1 |
What the finished NCT05516225 record still lists
NCT05516225 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which PBCLN-003 is the first listed.
NCT05516225 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05516225 about?
NCT05516225 is a clinical study titled "Safety Study of Human Milk Oligosaccharides in Healthy Adults". 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).
What is the current status of trial NCT05516225?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2016-09-29. Estimated completion is 2017-02-13.
What interventions are being tested in trial NCT05516225?
The interventions under investigation include: PBCLN-003 (DRUG).
Who is sponsoring clinical trial NCT05516225?
This trial is sponsored by Prolacta Bioscience, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05516225's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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