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Single Ascending Dose Study for Evaluation of Safety, Tolerability and Pharmacokinetics of L606 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT04041648•Pharmosa Biopharm Inc.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Males or females, of any race, 18 to 50 years of age, inclusive, at Screening.
•2. Body mass index between 18.5 and 32.0 kg/m2, inclusive, at Screening.
•3. 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).
•4. Ability of the subject to generate spirometry according to minimum ATS/ERS guidance criteria.
•5. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in Section 6.6.
•6. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
•7. Agree to abstain from consuming alcohol from 72 hours prior to Check-in.
•8. Agree to refrain from strenuous exercise from 7 days prior to Check-in.
•9. Agree to abstain from consuming foods and beverages containing poppy seeds, grapefruit, or Seville oranges from 7 days prior to Check-in.
•10. Agree to abstain from consuming caffeine-containing foods and beverages from 48 hours prior to Check-in.
+1 more criteria

Exclusion Criteria

•1. Clinically relevant abnormalities identified during Screening, physical examination, 12 lead ECG, or laboratory examinations.
•2. 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.
•3. 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).
•4. History of postural hypotension, unexplained syncope, or hypertension.
•5. History of asthma, chronic obstructive pulmonary disease (COPD), or reactive airways conditions or findings consistent with asthma or COPD on spirometry testing.
•6. Blood pressure \<90 mmHg systolic or \<50 mmHg diastolic after supine for 5 minutes at Screening or Check in upon repeat testing.
•7. Blood pressure \>150 mmHg systolic or \>90 mmHg diastolic after supine for 5 minutes at Screening or Check in upon repeat testing.
•8. Pulse rate \>100 bpm after supine for 5 minutes at Screening or Check-in upon repeat testing.
•9. 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.
•10. 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.
+19 more criteria

Locations (1)

PPD

Austin, Texas, United States

Key Dates

Start Date

November 9, 2018

Primary Completion Date

September 20, 2019

Completion Date

May 12, 2020

Last Updated

August 5, 2025

Enrollment

ACTUAL participants

Conditions

Pulmonary Arterial Hypertension

Interventions

L606 (Liposomal Treprostinil) Inhalation Solution 51ug

DRUG

L606 Inhalation System

DEVICE

Placebo Solution

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

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