Effect of RTB101 on Illness Associated With Respiratory Tract Infections in the Elderly

• Status: Withdrawn
• Trial end date: 2019-11-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if RTB101 prevents illness associated with respiratory tract infections in people ≥65 years of age.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Restorbio Inc.
• Treatments: Dactolisib

Criteria

Inclusion Criteria:

• Subjects must be ≥65 years of age

• Subjects should require no or minimal assistance with self-care and activities of daily living. Subjects in assisted-living or long-term care residential facilities that provide minimal assistance are eligible

• Sexually active male subjects with a partner of child-bearing potential must be willing to wear a condom while on study drug and for 1 week after stopping study drug and should not father a child in this period

Exclusion Criteria:

• Subjects who are current smokers, stopped smoking ≤ 1 year prior to screening, or have and a ≥ 10 pack year smoking history

• Subjects with a medical history of clinically significant lung diseases (including COPD) other than asthma

• Subjects with current evidence of a serious and/or unstable medical disorder

• Subjects with unstable cardiac conditions

• Subjects with a history of systemic autoimmune diseases

• Subjects with Type I diabetes mellitus

• Subjects with a history of immunodeficiency diseases, including a positive human immunodeficiency virus (HIV) test result

• Infection with Hepatitis B (HBV) or Hepatitis C (HCV)