MedTrace Logo

JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF

NCT03538301 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2023-12-11

Study results available
· View outcomes & findings →

Summary

A phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, biological activity, and pharmacokinetics (PK) of ND-L02-s0201 for Injection in subjects with IPF.

Conditions

Interventions

DRUG

ND-L02-s0201 (Low Dose)

Intravenous administration every 2 weeks

DRUG

ND-L02-s0201 (High Dose)

Intravenous administration every 2 weeks

OTHER

Other: Placebo

Saline

Sponsors & Collaborators

  • Nitto Denko Corporation

    lead INDUSTRY

Principal Investigators

  • Nitto Denko Corporation · Nitto Denko Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-18
Primary Completion
2022-08-24
Completion
2022-08-24
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Japan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03538301 on ClinicalTrials.gov