NCT05516225CompletedPhase 1
Phase 1 Safety Study of Human Milk Oligosaccharide Concentrate PBCLN-003 in Healthy Adult Volunteers
Prolacta Bioscience1 site in 1 country32 target enrollmentStarted: September 29, 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Number of Adverse Events
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
PBCLN-003, 1.8 g daily in 3 divided oral doses for 7 days
Experimental
Intervention: PBCLN-003 (Drug)
PBCLN-003, 3.6 g daily in 3 divided oral doses for 7 days
Experimental
Intervention: PBCLN-003 (Drug)
PBCLN-003, 9 g daily in 3 divided oral doses for 7 days
Experimental
Intervention: PBCLN-003 (Drug)
PBCLN-003, 18 g daily in 3 divided oral doses for 7 days
Experimental
Intervention: PBCLN-003 (Drug)
Outcomes
Primary Outcomes
Number of Adverse Events
Time Frame: 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 Outcomes
- Stool, saliva, and vaginal microbiome(28 days)
- Serum cytokine levels(28 days)
Investigators
Study Sites (1)
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