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Pulmonary Arterial HypertensionPhase 1NCT04041648

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

A Phase 1 study testing L606 (Liposomal Treprostinil) Inhalation Solution 51ug and L606 Inhalation System in people with Pulmonary Arterial Hypertension, run by Pharmosa Biopharm Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
L606 (Liposomal Treprostinil) Inhalation Solution 51ug and L606 Inhalation System
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
1 siteUnited States
Study dates
9 Nov 2018to 12 May 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Positive hepatitis panel and/or positive human immunodeficiency virus test at Screening.
  • Participation in a clinical study involving administration of an investigational drug (new chemical entity) within 30 days prior to Check-in.
  • Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's Wort, within 30 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
  • Use or intend to use any prescription medications/products within 14 days prior to Check-in with the exception of hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives, unless deemed acceptable by the Investigator (or designee).
  • Use or intend to use slow-release medications/products considered to still be active within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
  • Use or intend to use any nonprescription medications/products or herbal supplements within 7 days prior to Check-in, unless deemed acceptable by the Investigator (or designee). Use of nonsteroidal anti inflammatory drugs or aspirin is prohibited within 14 days prior to Check-in.
  • Receipt of blood products within 2 months prior to Check-in.
  • Donation of blood, plasma, and platelets, or the loss of a significant volume of blood (>450 mL) within 6 weeks prior to Screening.
  • Poor peripheral venous access.
  • Have a history of bleeding problems or abnormal bleeding tendencies.
  • Platelet or coagulation factor levels below the lower limit of normal, unless considered not clinically significant by the Investigator.
  • Have previously completed or withdrawn from this study or any other study investigating treprostinil, and have previously received the investigational product.
  • History of any recent infection within 2 weeks of Check-in.
  • In the opinion of the Investigator (or designee), should not participate in this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • PPD

    Austin, Texas, 78744

Other trials in United States

About this study

Official title: 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

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.

Read the 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).

Being tested
L606 (Liposomal Treprostinil) Inhalation Solution 51ug, L606 Inhalation System, Placebo Solution
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • L606 (Liposomal Treprostinil) Inhalation Solution 51ugDrug

    Also called Drug: L606 (Liposomal Treprostinil) Inhalation Solution

    Single ascending dose

  • L606 Inhalation SystemDevice

    Also called Device: L606 Inhalation Solution

    Single ascending dose

  • Placebo SolutionOther

    Single ascending dose

Study groups in NCT04041648
Study groupRoleWhat they receive
placeboPlacebo comparatorplacebo group
Receives: Device: L606 Inhalation System; Other: Placebo Solution
L606 Liposomal inhalation solutionExperimentalLiposomal inhalation solution
Receives: Drug: L606 (Liposomal Treprostinil) Inhalation Solution 51ug; Device: L606 Inhalation System

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From Pre-dose to Day 10

Secondary outcomes (12)

  1. AUC0-2hr

    area under curve from time zero to 2 hours postdose

    Measured: From pre-dose to 24 hours post dose

  2. AUC0-4hr

    AUC from time zero to 4 hours postdose

    Measured: From pre-dose to 24 hours post dose

  3. AUC0-8hr

    area under curve from time zero to 8 hours postdose

    Measured: From pre-dose to 24 hours post dose

  4. AUC0-12hr

    area under curve from time zero to 12 hours postdose

    Measured: From pre-dose to 24 hours post dose

  5. AUC0-24hr

    area under curve from time zero to 24 hours postdose

    Measured: From pre-dose to 24 hours post dose

  6. AUC0-tlast

    AUC from time zero to the time of the last quantifiable concentration

    Measured: From pre-dose to 24 hours post dose

  7. AUC0-∞

    area under curve from time zero to infinite

    Measured: From pre-dose to 24 hours post dose

  8. Cmax

    maximum plasma concentration

    Measured: From pre-dose to 24 hours post dose

  9. tmax

    time to Maximum Plasma Concentration

    Measured: From pre-dose to 24 hours post dose

  10. t1/2

    time to half-life

    Measured: From pre-dose to 24 hours post dose

  11. CL/F

    apparent total plasma clearance

    Measured: From pre-dose to 24 hours post dose

  12. Vz/F

    apparent volume of distribution during terminal phase

    Measured: From pre-dose to 24 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2019
  2. Study start9 Nov 2018
  3. Primary completion20 Sep 2019
  4. Study completion12 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04041648
Sponsor's protocol ID
PBI L606_2.0
Status last verified
Jul 2025
First submitted
23 Jul 2019
Last updated
5 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing L606 (Liposomal Treprostinil) Inhalation Solution 51ug and L606 Inhalation System in people with Pulmonary Arterial Hypertension, run by Pharmosa Biopharm Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of treatment-emergent adverse events for L606 and placebo, including abnormal laboratory events (time frame: From Pre-dose to Day 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04041648.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.

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