NCT03830125

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBT-877 in Healthy Subjects

A Phase 1, 2-Stage, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBT-877 Following Single and Multiple Ascending Doses in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (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-877. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses of BBT-877 in healthy adult subjects.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	BBT-877, Single dose	Single dose of BBT-877, 5 dose levels, oral capsule
DRUG	Placebo group	Placebo matched to BBT-877, oral capsule
DRUG	BBT-877, Multiple doses	Multiple doses of BBT-877, 14 days, 8 dose levels, oral capsule

Timeline

• Start date: 2019-02-13
• Primary completion: 2019-11-24
• Completion: 2019-11-24
• First posted: 2019-02-05
• Last updated: 2020-01-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study