Safety Study of Human Milk Oligosaccharides in Healthy Adults

Phase 1 Safety Study of Human Milk Oligosaccharide Concentrate PBCLN-003 in Healthy Adult Volunteers

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).

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