NCT03392896View on ClinicalTrials.gov

Study of DCR-PHXC-101 in Normal Healthy Volunteers and Patients With Primary Hyperoxaluria

PHASE1CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

December 6, 2017

Primary Completion Date

November 19, 2019

Study Completion Date

November 19, 2019

Conditions
Primary Hyperoxaluria
Interventions
DRUG

DCR-PHXC

DCR-PHXC is a novel, potent, and long-acting small interference ribonucleic acid (siRNA) molecule conjugated to N-acteylgalactosamine (GalNAc) that is designed to decrease liver oxalate production. DCR-PHXC is delivered via subcutaneous (SC) injection.

DRUG

Placebo

Single SC administration of placebo, which will be a sterile, preservative-free normal saline 0.9% solution for SC injection, which is of similar osmolality to the DCR-PHXC formulation.

Trial Locations (7)

53127

Universitätsklinikum Bonn-Institut für Klinische Chemie und Klinische Pharmakologie, Bonn

69677

Centre d'Investigation Clinique - CIC 1407 - Hospices Civils de Lyon, Bron

02115

Boston Children's Hospital, Boston

1012 WX

University of Amsterdam, Amsterdam

B15 2GW

Queen Elizabeth Hospital Birmingham, Birmingham

B4 6NH

Birmingham Children's Hospital NHS Trust, Birmingham

CF484DR

Clinical Trial Site, Wales

All Listed Sponsors
lead

Dicerna Pharmaceuticals, Inc., a Novo Nordisk company

INDUSTRY

NCT03392896 - Study of DCR-PHXC-101 in Normal Healthy Volunteers and Patients With Primary Hyperoxaluria | Biotech Hunter | Biotech Hunter