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Single Ascending Dose Study for Evaluation of Safety, Tolerability and Pharmacokinetics of L606

NCT04041648 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-08-05

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the Pharmacokinetics, Safety and Tolerability of L606 (Liposomal Treprostinil) Inhalation Solution in Single Ascending Dose study design in healthy volunteers.

Conditions

Interventions

DRUG

L606 (Liposomal Treprostinil) Inhalation Solution 51ug

Single ascending dose

DEVICE

L606 Inhalation System

Single ascending dose

OTHER

Placebo Solution

Single ascending dose

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • Pharmosa Biopharm Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas L Hunt, MD, PhD · Pharmosa Biopharm Inc.PPD

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-09
Primary Completion
2019-09-20
Completion
2020-05-12
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

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 NCT04041648 on ClinicalTrials.gov