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Clinical trial

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

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Last updated:18th Jun 2018
Identifier: NCT03538301

This phase 2 clinical study will be a 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.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Biological Activity, and PK of ND-L02-s0201 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Actual Study Start Date: June 18, 2018
Estimated Primary Completion Date: March 2020
Estimated Study Completion Date: January 2021

Arms:
- Experimental:
ND-L02-s0201 (Dose Level 1)
- Experimental: ND-L02-s0201 (Dose Level 2)
- Placebo Comparator: Placebo

Category Value
Date last updated at source 2019-10-10
Study type(s) Interventional
Expected enrolment 120
Study start date 2018-06-18
Estimated primary completion date 2020-03-01

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