Healthy
Conditions
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).
Interventions
DRUGPBCLN-003
Human Milk Oligosaccharide Concentrate
Sponsors
Prolacta Bioscience
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed