NCT03647228View on ClinicalTrials.gov

A Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of IONIS-ENaCRx in Healthy Volunteers and Patients With Cystic Fibrosis

PHASE1CompletedINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

December 13, 2018

Primary Completion Date

October 13, 2020

Study Completion Date

October 13, 2020

Conditions
Healthy SubjectsCystic Fibrosis
Interventions
DRUG

IONIS-ENaCRx

Ascending single and multiple doses of IONIS-ENaCRx inhaled or nebulized.

DRUG

Placebo

Placebo comparator calculated volume to match active comparator inhaled or nebulized.

Trial Locations (8)

45239

Universitätsmedizin Essen, Essen

81241

Lungenheilkunde München-Pasing, München

D-60589

Universitätsklinikum Frankfurt, Frankfurt

M23 9QZ

Medicines Evaluation Unit, Wythenshawe

BT9 6AD

Celerion, Belfast

EH4 2XU

Western General Hospital, Edinburgh

SE5 9RS

Adults Cystic Fibrosis King's College Hospital - Hambleden Wing (East), London

SW3 6HP

Royal Brompton Hospital, London

Sponsors
All Listed Sponsors
lead

Ionis Pharmaceuticals, Inc.

INDUSTRY

NCT03647228 - A Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of IONIS-ENaCRx in Healthy Volunteers and Patients With Cystic Fibrosis | Biotech Hunter | Biotech Hunter