Study Designed to Assess the Safety, Tolerability and PK of PTI-808 in Healthy Volunteers and in Adults With Cystic Fibrosis

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

179

Participants

Timeline

Start Date

July 17, 2017

Primary Completion Date

December 23, 2019

Study Completion Date

December 23, 2019

Conditions
Healthy Volunteer - CompleteCystic Fibrosis - Complete
Interventions
DRUG

PTI-808

Active

DRUG

Placebo

Placebo

DRUG

PTI-428

Active

DRUG

PTI-801

Active

Trial Locations (48)

1010

Auckland Clinical Studies Ltd., Grafton

1090

Universitair ziekenhuis Brussel, Brussels

2100

University of Copenhagen Rigshospitalet, Copenhagen

2305

John Hunter Hospital, Lambton

3000

UZ Leuven, Leuven

10117

Charité Universitätsmedizin Berlin, Berlin

10595

New York Medical College, Valhalla

19104

Children's Hospital of Philadelphia, Philadelphia

21287

Johns Hopkins University, Baltimore

27517

University of North Carolina at Chapel Hill, Chapel Hill

29425

Medical University of South Carolina, Charleston

30322

Emory Children's Center, Atlanta

32803

Central Florida Pulmonary Group, Altamonte Springs

33600

Hôpital Haut Lévêque, Pessac

44093

Hôpital Guillaume-et-René-Laennec, Nantes

45239

Universitätsklinikum Essen, Essen

48109

Michigan Medicine, University of Michigan, Ann Arbor

48201

Harper University Hospital, Detroit

50937

University Hospital Cologne, Cologne

51092

Hôpital Maison Blanche Maladies respiratoires et allergologie, Reims

55455

University of Minnesota, Minneapolis

59101

Billings Clinic, Billings

60590

Klinikum der J.W. Goethe Universität, Frankfurt

60611

Northwestern Memorial Hospital, Chicago

64108

Children's Mercy, Kansas City

68198

University of Nebraska Medical Center, Omaha

69495

Hospices Civils de Lyon, Lyon

75014

Hôpital Cochin, Paris

78209

ICON Early Phase Services, San Antonio

80206

National Jewish Health, Denver

81377

Klinikum des Universität München, München

84132

University of Utah, Salt Lake City

85724

Banner University of Arizona Medical Center, Tucson

94305

Stanford University Medical Center, Stanford

02114

Massachusetts General Hospital, Boston

02115

Boston Children's Hospital, Boston

03756

Dartmouth Hitchcock Medical Center, Lebanon

V6Z1Y6

St. Paul's Hospital, Vancouver

H2X3E4

Centre hospitalier de l'Université de Montréal (CHUM), Montreal

H4A3J1

McGill University Health Centre, Montreal

G1V4G5

Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval, Québec

06001

Hôpital Pasteur, Nice

EX2 5DW

Royal Devon and Exeter Hospital, Exeter

EH42XU

Western General Hospital, Edinburgh

B9 5SS

Birmingham Heartlands Hospital, Birmingham

BT9 7AB

Belfast City Hospital, Belfast

SE59RS

King's College Hospital, London

SO16 6YD

University Hospital Southampton, Southampton

All Listed Sponsors
lead

Proteostasis Therapeutics, Inc.

INDUSTRY

NCT03251092 - Study Designed to Assess the Safety, Tolerability and PK of PTI-808 in Healthy Volunteers and in Adults With Cystic Fibrosis | Biotech Hunter | Biotech Hunter