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NCT03392896COMPLETEDanonymous

A Placebo-Controlled, Single-Blind, Single-Center Phase 1 Study in Normal Healthy Volunteers and Open-Label Multi-Center Study in Patients With Primary Hyperoxaluria to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of DCR-PHXC Solution for Injection (Subcutaneous Use)

Sponsor

Source record

Dicerna Pharmaceuticals, Inc., a Novo Nordisk company

Phase

Source record

PHASE1

Modality

AI-normalized

RNA therapy

Target

AI-normalized

DCR-PHXC, Placebo

Indication / condition

AI-normalized

Primary Hyperoxaluria

Intervention

Source record

DCR-PHXC, Placebo

Source & freshness

Source record

NCT ID

NCT03392896

Original source

ClinicalTrials.gov

Source last updated

Sep 19, 2024

Ingested at

Jun 11, 2026

Internal sync

Jun 11, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT03392896

Title

A Placebo-Controlled, Single-Blind, Single-Center Phase 1 Study in Normal Healthy Volunteers and Open-Label Multi-Center Study in Patients With Primary Hyperoxaluria to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of DCR-PHXC Solution for Injection (Subcutaneous Use)

Sponsor

Dicerna Pharmaceuticals, Inc., a Novo Nordisk company

Status

COMPLETED

Phase

PHASE1

Condition raw

Primary Hyperoxaluria

Condition normalized

Primary Hyperoxaluria

Modality raw

RNA therapy

Modality normalized

RNA therapy

Target raw

DCR-PHXC, Placebo

Target normalized

DCR-PHXC, Placebo

Interventions

DCR-PHXC, Placebo

Public preview

Source record

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).

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

A Placebo-Controlled, Single-Blind, Single-Center Phase 1 Study in Normal Healthy Volunteers and Open-Label Multi-Center Study in Patients With Primary Hyperoxaluria to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of DCR-PHXC Solution for Injection (Subcutaneous Use)

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT03392896

Status

COMPLETED

Phase

PHASE1

Sponsor

Dicerna Pharmaceuticals, Inc., a Novo Nordisk company

Executive brief

Investment-Ready Snapshot

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).

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedSep 19, 2024
Internal syncJun 11, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT03392896

Indication

Primary Hyperoxaluria

Modality

RNA therapy

Target

DCR-PHXC, Placebo

Intervention

DCR-PHXC, Placebo

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.