Clinical Trials/NCT04041648

NCT04041648

Completed

Phase 1

A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dose of L606 for Inhalation in Healthy Subjects

Pharmosa Biopharm Inc.1 site in 1 country52 target enrollmentNovember 9, 2018

ConditionsPulmonary Arterial Hypertension

InterventionsL606 Inhalation System Placebo Solution L606 (Liposomal Treprostinil) Inhalation Solution 51ug

DrugsL606 (Liposomal Treprostinil) Inhalation Solution 51ug

Overview

Phase: Phase 1
Intervention: L606 Inhalation System
Conditions: Pulmonary Arterial Hypertension
Sponsor: Pharmosa Biopharm Inc.
Enrollment: 52
Locations: 1
Primary Endpoint: The number of treatment-emergent adverse events for L606 and placebo, including abnormal laboratory events
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

L606 (Liposomal Treprostinil) Inhalation Solution and dedicated inhalation system is developed by Pharmosa Biopharm Inc. intended to improve the inconvenience, as one of the greatest impediments to patient satisfaction to current inhaled treprostinil therapy. Pharmosa's liposomal technology offers sustained release of treprostinil which enable bid treatment instead of conventional qid treatment offered by current inhaled treprostinil therapy for treatment of patients with PAH (WHO Group 1).

Registry

clinicaltrials.gov

Start Date

November 9, 2018

End Date

May 12, 2020

Last Updated

9 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Pharmosa Biopharm Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males or females, of any race, 18 to 50 years of age, inclusive, at Screening.
•Body mass index between 18.5 and 32.0 kg/m2, inclusive, at Screening.
•In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[eg, Gilbert's syndrome\] is not acceptable) at Screening or Check in as assessed by the Investigator (or designee).
•Ability of the subject to generate spirometry according to minimum ATS/ERS guidance criteria.
•Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in Section 6.
•Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
•Agree to abstain from consuming alcohol from 72 hours prior to Check-in.
•Agree to refrain from strenuous exercise from 7 days prior to Check-in.
•Agree to abstain from consuming foods and beverages containing poppy seeds, grapefruit, or Seville oranges from 7 days prior to Check-in.
•Agree to abstain from consuming caffeine-containing foods and beverages from 48 hours prior to Check-in.

Exclusion Criteria

•Clinically relevant abnormalities identified during Screening, physical examination, 12 lead ECG, or laboratory examinations.
•Clinically significant history of hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, genitourinary, and/or musculoskeletal disease, glaucoma, psychiatric disorder, or any other chronic disease, whether controlled by medication or not.
•History of anaphylaxis, significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless deemed not clinically significant by the Investigator (or designee).
•History of postural hypotension, unexplained syncope, or hypertension.
•History of asthma, chronic obstructive pulmonary disease (COPD), or reactive airways conditions or findings consistent with asthma or COPD on spirometry testing.
•Blood pressure \<90 mmHg systolic or \<50 mmHg diastolic after supine for 5 minutes at Screening or Check in upon repeat testing.
•Blood pressure \>150 mmHg systolic or \>90 mmHg diastolic after supine for 5 minutes at Screening or Check in upon repeat testing.
•Pulse rate \>100 bpm after supine for 5 minutes at Screening or Check-in upon repeat testing.
•Have a pre-existing condition that could interfere with the absorption, distribution, metabolism, or excretion of drugs. Cholecystectomy is permitted if done at least 10 days before enrollment.
•Use tobacco- or nicotine-containing products within 6 months prior to Check-in, or have a history of \>1 pack cigarettes daily use over multiple years of smoking.

Arms & Interventions

placebo

placebo group

Intervention: L606 Inhalation System

placebo

placebo group

Intervention: Placebo Solution

L606 Liposomal inhalation solution

Liposomal inhalation solution

Intervention: L606 (Liposomal Treprostinil) Inhalation Solution 51ug

L606 Liposomal inhalation solution

Liposomal inhalation solution

Intervention: L606 Inhalation System

Outcomes

Primary Outcomes

The number of treatment-emergent adverse events for L606 and placebo, including abnormal laboratory events

Time Frame: From Pre-dose to Day 10

Frequency, severity and seriousness of adverse events (AE) including physical examination, incident of laboratory abnormalities, 12-lead ECG parameter and vital sign assessment