Study Designed to Assess the Safety, Tolerability and PK of PTI-808 in Healthy Volunteers and in Adults With Cystic Fibrosis
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Healthy Volunteer - Complete, Cystic Fibrosis - Complete
In brief
Part 1 of this trial will enroll healthy volunteers into a single ascending dose (SAD), multiple ascending dose (MAD), and Food Effect (FE) treatment groups. The SAD treatment group is comprised of at least 3 ascending dose level cohorts where healthy adult subjects will be randomized to receive a single dose of either PTI-808 or placebo and will be followed for 7 days post dose. A safety review committee (SRC) will convene after the completion of each cohort to evaluate safety and pharmacokinetic (PK) data. Following the conclusion of the respective SAD level dose groups and after sufficient review of study data and approval by the SRC, a second set of healthy adult subjects will participate in an assigned MAD treatment group. The MAD treatment group is comprised of 3 ascending dose level cohorts where subjects will be randomized to receive either PTI-808 or placebo daily for 7 days and will be followed for 7 days after receiving the last dose. Also following the conclusion of the respective SAD level dose groups, healthy adult subjects will participate in the FE treatment group. Part 2 of this will enroll healthy volunteers to assess the safety, tolerability, and PK of PTI 808 co administered with PTI 801 and PTI 428 to HVs with daily dosing for 7 consecutive days. Part 3 will enroll adult subjects with cystic fibrosis (CF) into a MAD treatment group consisting of 2 cohorts. Subjects will receive PTI-808 co-administered with PTI-801 and PTI-428. PTI-808 will be administered daily for 7 consecutive days followed by PTI-808 + PTI-801 + PTI-428 administered daily for 14 consecutive days. Part 4 will enroll adult subjects with cystic fibrosis (CF) into 28-day cohorts. Subjects will receive PTI-808 co-administered with PTI-801 with or without PTI-428 versus matching placebo.
Key facts
- Study ID
- NCT03251092
- Run by
- Proteostasis Therapeutics, Inc.
- People needed
- 179
- Starts
- 2017-07-17
- Expected to finish
- 2019-12-23
- Last updated by the study team
- 2020-04-22
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.
Where it is running
- Banner University of Arizona Medical Center — Tucson, Arizona, United States
- Stanford University Medical Center — Stanford, California, United States
- National Jewish Health — Denver, Colorado, United States
- Central Florida Pulmonary Group — Altamonte Springs, Florida, United States
- Emory Children's Center — Atlanta, Georgia, United States
- Northwestern Memorial Hospital — Chicago, Illinois, United States
- Johns Hopkins University — Baltimore, Maryland, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Boston Children's Hospital — Boston, Massachusetts, United States
- Michigan Medicine, University of Michigan — Ann Arbor, Michigan, United States
- Harper University Hospital — Detroit, Michigan, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Children's Mercy — Kansas City, Missouri, United States
- Billings Clinic — Billings, Montana, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
- New York Medical College — Valhalla, New York, United States
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- ICON Early Phase Services — San Antonio, Texas, United States
- University of Utah — Salt Lake City, Utah, United States
- John Hunter Hospital — Lambton, New South Wales, Australia
- Universitair ziekenhuis Brussel — Brussels, Belgium
- UZ Leuven — Leuven, Belgium
Full record on ClinicalTrials.gov
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