NCT03482648

First-In-Human Study of BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Volunteers

A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Novel Oral Peptide BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Bridge Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This clinical trial is the first-in-human study of BBT-401-1S. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses of BBT-401-1S in healthy adult subjects.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	BBT-401-1S, Single dose	Single dose of BBT-401-1S, 7 dose levels, oral capsule
DRUG	BBT-401-1S, Multiple doses	Multiple doses of BBT-401-1S, 7 days, 3 dose levels, oral capsule
DRUG	Placebo	Placebo matched to BBT-401-1S, oral capsule

Timeline

• Start date: 2018-03-20
• Primary completion: 2018-09-26
• Completion: 2018-10-03
• First posted: 2018-03-29
• Last updated: 2021-07-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study