Safety Study of Human Milk Oligosaccharides in Healthy Adults

• Status: Completed
• Trial end date: 2017-02-13
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Prolacta Bioscience

Criteria

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