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NCT03392896 · ClinicalTrials.gov registry record · Phase 1
Study of DCR-PHXC-101 in Normal Healthy Volunteers and Patients With Primary Hyperoxaluria
A Phase 1 study, sponsored by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT03392896 is a Phase 1 study that has completed, run by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company. The registered enrollment target is 43 participants.
The verdict
NCT03392896, a Phase 1 study, has completed, sponsored by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
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).
Interventions
- DRUG Placebo
- DRUG DCR-PHXC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2017-12-06 |
| Est. Completion | 2019-11-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03392896
The ClinicalTrials.gov registry entry for NCT03392896 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dicerna Pharmaceuticals, Inc., a Novo Nordisk company, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03392896 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03392896 about?
NCT03392896 is a clinical study titled "Study of DCR-PHXC-101 in Normal Healthy Volunteers and Patients With Primary Hyperoxaluria". 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 s...
What is the current status of trial NCT03392896?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2017-12-06. Estimated completion is 2019-11-19.
What interventions are being tested in trial NCT03392896?
The interventions under investigation include: Placebo (DRUG), DCR-PHXC (DRUG).
Who is sponsoring clinical trial NCT03392896?
This trial is sponsored by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company, which has 13 total clinical trials registered on ClinicalTrials.gov.
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