NCT02748642

A Study to Investigate the Safety, Pharmacokinetics, and Immunogenicity of BITS7201A in Healthy Volunteers and Participants With Mild Atopic Asthma

A Phase I, Randomized, Observer-Blinded, Placebo-Controlled, Single and Multiple Ascending-Dose Study to Investigate the Safety, Pharmacokinetics, and Immunogenecity of BITS7201A in Healthy Volunteers and Patients With Mild Atopic Asthma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This randomized, observer-blinded, placebo-controlled, single and multiple ascending-dose study will be conducted in two parts to evaluate the safety, pharmacokinetics, and immunogenicity of BITS7201A. Part A will be an ascending, single-dose, sequential-group study where participants will be randomly assigned to active drug or placebo. Part B will be an ascending, multiple-dose, sequential-group study where participants will be randomized to active drug or placebo. Total length of the study is anticipated to be approximately 12 months.

Conditions

• Mild Atopic Asthma

Interventions

Type	Name	Description
DRUG	BITS7201A	BITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B.
DRUG	Placebo	Placebo matched to BITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B.

Timeline

• Start date: 2016-04-07
• Primary completion: 2017-06-14
• Completion: 2017-06-14
• First posted: 2016-04-22
• Last updated: 2018-07-03

Locations

1 site across 1 country: United States