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

NCT04041648 | Completed Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: PBI L606_2.0
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

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

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

  From Pre-dose to Day 10

Secondary Outcomes (12)

• AUC0-2hr

  From pre-dose to 24 hours post dose

• AUC0-4hr

  From pre-dose to 24 hours post dose

• AUC0-8hr

  From pre-dose to 24 hours post dose

• AUC0-12hr

  From pre-dose to 24 hours post dose

• AUC0-24hr

  From pre-dose to 24 hours post dose

Study Arms (2)

placebo

PLACEBO COMPARATOR

placebo group

Device: L606 Inhalation System; Other: Placebo Solution

L606 Liposomal inhalation solution

EXPERIMENTAL

Liposomal inhalation solution

Drug: L606 (Liposomal Treprostinil) Inhalation Solution 51ug; Device: L606 Inhalation System

Interventions

L606 (Liposomal Treprostinil) Inhalation Solution 51ug DRUG

Single ascending dose

Also known as: Drug: L606 (Liposomal Treprostinil) Inhalation Solution

L606 Liposomal inhalation solution

L606 Inhalation System DEVICE

Single ascending dose

Also known as: Device: L606 Inhalation Solution

L606 Liposomal inhalation solution; placebo

Placebo Solution OTHER

Single ascending dose

placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 6.6.
• 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.
• Agree to abstain from consuming carbonated drinks (including sparkling water and soda) from 48 hours prior to Check-in and until end of study.

You may not qualify if:

• 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.
• History of alcoholism or drug/chemical abuse within 2 years prior to Check-in.
• Have a history of alcohol abuse or a history of or current impairment of organ function reasonably related to alcohol abuse.
• Have a history of or current evidence of abuse of licit or illicit drugs or a positive urine screen for drugs of abuse.
• Alcohol consumption of \>21 units per week. One unit of alcohol equals 12 oz (360 mL) beer, 1.5 oz (45 mL) liquor, or 5 oz (150 mL) wine.
• Positive urine drug screen (including alcohol and cotinine) at Screening and/or Check-in.

Sponsors & Collaborators

• Pharmosa Biopharm Inc.: lead
• PPD Development, LP: collaborator

Study Sites (1)

PPD

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Thomas L Hunt, MD, PhD

  Pharmosa Biopharm Inc.PPD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: August 1, 2019
• Study Start: November 9, 2018
• Primary Completion: September 20, 2019
• Study Completion: May 12, 2020
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)