Study of DCR-PHXC-101 in Normal Healthy Volunteers and Patients With Primary Hyperoxaluria
Completed · Phase 1 · Has a placebo group
Conditions studied: Primary Hyperoxaluria
In brief
This is a double-blind, placebo-controlled, dose escalation trial of DCR-PHXC in Healthy Volunteers (HVs) and patients with Primary Hyperoxaluria (PH). Once safety has been established in HV, PH patients with a confirmed diagnosis of PH1 and PH2 will be enrolled across multiple dosing cohorts. The study design will allow enrollment of PH patient cohorts at a given dose level once safety has been demonstrated in HV at that dose level. The study will be conducted in two parts: Part A: Single ascending dose (SAD) in HV; Part B: SAD in patients with PH1 and PH2 (lagging Part A by 1 dose level cohort).
Key facts
- Study ID
- NCT03392896
- Run by
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
- People needed
- 43
- Starts
- 2017-12-06
- Expected to finish
- 2019-11-19
- Last updated by the study team
- 2024-09-19
Who can join
Age: 6 and older. Sex: any. Healthy volunteers: accepted.
Where it is running
- Boston Children's Hospital — Boston, Massachusetts, United States
- Centre d'Investigation Clinique - CIC 1407 - Hospices Civils de Lyon — Bron, France
- Universitätsklinikum Bonn-Institut für Klinische Chemie und Klinische Pharmakologie — Bonn, Germany
- University of Amsterdam — Amsterdam, Netherlands
- Queen Elizabeth Hospital Birmingham — Birmingham, United Kingdom
- Birmingham Children's Hospital NHS Trust — Birmingham, United Kingdom
- Clinical Trial Site — Wales, United Kingdom
Full record on ClinicalTrials.gov
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