Safety Study of Human Milk Oligosaccharides in Healthy Adults

Prolacta Bioscience

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PBCLN-003

Study type: Interventional

Funder types: Industry

Identifiers

NCT05516225

16-CLN-003

Details and patient eligibility

About

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).

Enrollment: 32 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

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

Experimental group

Treatment:

Drug: PBCLN-003

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

Experimental group

Treatment:

Drug: PBCLN-003

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

Experimental group

Treatment:

Drug: PBCLN-003

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

Experimental group

Treatment:

Drug: PBCLN-003