A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension

March 26, 2026 updated by: Insmed Incorporated

A Phase 2b, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension

The main objective of the study is to assess the effect of treprostinil palmitil inhalation powder (TPIP) compared with placebo on pulmonary vascular resistance.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Cuiudad Autónoma de Buenos Aires, Argentina, C1430EGF
        • ARG008
      • Córdoba, Argentina, X5000FPQ
        • ARG001
      • Córdoba, Argentina, X5000DCE
        • ARG004
    • Buenos Aires
      • Quilmes, Buenos Aires, Argentina, B1878GEG
        • ARG009
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2013KDS
        • ARG006
      • Rosario, Santa Fe Province, Argentina, S2013DSR
        • ARG002
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
        • ARG007
  • Australia
    • New South Wales
      • New Lambton Heights, New South Wales, Australia, 2305
        • AUS005
    • Queensland
      • Milton, Queensland, Australia, 4064
        • AUS004
      • Woolloongabba, Queensland, Australia, 4102
        • AUS001
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • AUS003
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • AUS002
  • Austria
      • Vienna, Austria, 1090
        • AUT001
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • AUT002
  • Belgium
      • Liège, Belgium, 4000
        • BEL001
    • Brussels Capital
      • Anderlecht, Brussels Capital, Belgium, 1070
        • BEL003
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • BEL002
  • Brazil
      • São Paulo, Brazil, 05403-000
        • BRA001
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130
        • BRA003
      • Belo Horizonte, Minas Gerais, Brazil, 30441-070
        • BRA004
    • Rio Grande do Sul
      • Passo Fundo, Rio Grande do Sul, Brazil, 99010-120
        • BRA007
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
        • BRA006
    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil, 80440-080
        • BRA002
  • Denmark
    • Central Jutland
      • Aarhus N, Central Jutland, Denmark, 8200
        • DNK001
  • Germany
      • Berlin, Germany, 12683
        • GER007
      • Munich, Germany, 80639
        • GER003
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69126
        • GER005
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • GER006
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 6120
        • GER001
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23562
        • GER002
  • Italy
      • Roma, Italy, 00161
        • ITA004
    • Campania
      • Naples, Campania, Italy, 80131
        • ITA003
    • Lombardy
      • Milan, Lombardy, Italy, 20123
        • ITA006
      • Monza, Lombardy, Italy, 20900
        • ITA005
      • Pavia, Lombardy, Italy, 27100
        • ITA002
    • Sicily
      • Palermo, Sicily, Italy, 90127
        • ITA001
  • Japan
    • Hokkaidô
      • Sapporo, Hokkaidô, Japan, 060-8543
        • JPN005
      • Sapporo, Hokkaidô, Japan, 060-8648
        • JPN004
    • Hukuoka
      • Kurume-Shi, Hukuoka, Japan, 830-0011
        • JPN007
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 305-8576
        • JPN006
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 890-8520
        • JPN001
    • Nagasaki
      • Nagasaki, Nagasaki, Japan, 852-8501
        • JPN009
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 701-1154
        • JPN002
    • Tokyo
      • Shinjuku-Ku, Tokyo, Japan, 160-8582
        • JPN008
    • Ôsaka
      • Suita-Shi, Ôsaka, Japan, 564-8565
        • JPN003
  • Malaysia
    • Kedah
      • Alor Star, Kedah, Malaysia, 05460
        • MYS005
    • Pahang
      • Kuantan, Pahang, Malaysia, 25200
        • MYS002
    • Selangor
      • Kajang, Selangor, Malaysia, 43000
        • MYS003
      • Sungai Buloh, Selangor, Malaysia, 47000
        • MYS004
  • Mexico
      • San Luis Potosí City, Mexico, 78200
        • MEX004
      • Sertoma, Mexico, 64718
        • MEX001
    • Jalisco
      • Lomas de Guevara, Jalisco, Mexico, 44657
        • MEX005
    • Mexico City
      • Mexico City, Mexico City, Mexico, 14080
        • MEX003
  • Philippines
      • Makati City, Philippines, 1229
        • PHL002
    • National Capital Region
      • Quezon City, National Capital Region, Philippines, 1100
        • PHL001
  • Serbia
      • Belgrade, Serbia, 11000
        • SRB001
      • Belgrade, Serbia, 11000
        • SRB003
    • Belgrade
      • Belgrade, Belgrade, Serbia, 116550
        • SRB004
  • Spain
      • Barcelona, Spain, 8025
        • ESP002
      • Las Palmas, Spain, 35010
        • ESP007
      • Madrid, Spain, 28046
        • ESP008
      • Seville, Spain, 41009
        • ESP003
      • Toledo, Spain, 45007
        • ESP004
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 07010
        • ESP006
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • ESP001
  • Switzerland
    • Vaud (fr)
      • Lausanne, Vaud (fr), Switzerland, CH-1011
        • CHE002
  • United Kingdom
      • London, United Kingdom, NW3 2Q
        • GBR004
    • Avon
      • Bath, Avon, United Kingdom, BA1 3NG
        • GBR001
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G81 4HX
        • GBR002
    • London, City of
      • London, London, City of, United Kingdom, W12 0HS
        • GBR006
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE3 3HD
        • GBR003
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • USA025
      • Scottsdale, Arizona, United States, 85258
        • USA022
      • Tucson, Arizona, United States, 85724
        • USA021
    • California
      • Sacramento, California, United States, 95817
        • USA023
      • West Hollywood, California, United States, 90048
        • USA002
    • Florida
      • Gainesville, Florida, United States, 32610
        • USA008
      • Jacksonville, Florida, United States, 32224
        • USA005
      • Orlando, Florida, United States, 32803
        • USA007
      • Tampa, Florida, United States, 33601
        • USA011
      • Winter Park, Florida, United States, 32792-3800
        • USA010
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • USA009
    • Illinois
      • Chicago, Illinois, United States, 60611
        • USA006
      • Chicago, Illinois, United States, 60612
        • USA001
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • USA013
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • USA014
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • USA003
    • New York
      • New York, New York, United States, 10021
        • USA102
      • New York, New York, United States, 10032-1559
        • USA017
    • Texas
      • Dallas, Texas, United States, 75246
        • USA016
      • Denison, Texas, United States, 75020
        • USA012
      • Houston, Texas, United States, 77030
        • USA018

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must be ≥ 18 to ≤ 75 years at the time of signing the informed consent form (ICF).

  • Participants must have a diagnosis of World Health Organization (WHO) Group 1 Pulmonary Hypertension (PH) [pulmonary arterial hypertension (PAH)] in any of the following subtypes:

    1. Idiopathic
    2. Heritable
    3. Drug/toxin-induced or connective tissue disease (CTD)-associated PAH
    4. Congenital heart disease-related with simple systemic-to-pulmonary shunt at least 1 year following repair.
  • PAH diagnosis for at least 3 months.

  • Participants must be on stable PH therapy consisting of up to 2 medications from the following classes:

    1. Endothelin receptor antagonists (eg, ambrisentan, bosentan, macitentan)
    2. Phosphoesterase type 5 inhibitors (eg, sildenafil, tadalafil)
    3. Guanylate cyclase stimulator (eg, riociguat)
  • No change in PH medications (eg, ambrisentan, bosentan, macitentan, sildenafil, tadalafil, riociguat) or dosage for at least 30 days prior to Screening.
  • No change in long-term diuretic use or dosage for at least 30 days prior to Screening.
  • Body Mass Index (BMI) within the range 18.0-37.0 kg/m^2 (inclusive).
  • Male participants: Male participants who are not sterile and have female partners of childbearing potential, must be using effective contraception from Day 1 to at least 90 days after the last dose of study drug.
  • Female participants: Women must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, (ie, post-tubal ligation for at least 12 months) or using highly effective contraception methods (ie, methods that alone or in combination achieve <1% unintended pregnancy rates per year when used consistently and correctly) from Day 1 to at least 90 days after the last dose of study drug.
  • Male participants with pregnant or non-pregnant woman of childbearing potential partner must use a condom in order to avoid potential exposure to embryo/fetus.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.

Exclusion Criteria:

  • History of PH other than idiopathic, hereditary, drug/toxin-induced, repaired simple congenital heart disease, or CTD-associated PAH (eg, complex, congenital heart disease-associated PAH, portal hypertension-associated PAH, PH belonging to Groups 2 through 5).
  • Allergy, or documented hypersensitivity or contraindication, to TPIP or Treprostinil or mannitol (an excipient of the TPIP formulation).
  • Any known ventricular or supraventricular tachyarrhythmia except for paroxysmal atrial fibrillation and any symptomatic bradycardia.
  • History of heart disease including left ventricular ejection fraction (LVEF) ≤ 40% or clinically significant valvular, constrictive, or symptomatic atherosclerotic heart disease (eg, stable angina, myocardial infarction, etc).
  • Participation in a cardio-pulmonary rehabilitation program within 1 month of Screening Visit.
  • Evidence of thromboembolic disease as assessed by ventilation-perfusion (VQ) scan, pulmonary angiography, or pulmonary computed tomography (CT) scan.
  • Active liver disease or hepatic dysfunction.
  • History of HIV infection.
  • Established diagnosis of hepatitis B viral infection, or positive for hepatitis B surface antigen (HBsAg) at the time of Screening.
  • Established diagnosis of hepatitis C viral infection at the time of screening.
  • Active and current symptomatic coronavirus disease 2019 (COVID-19) or previous severe disease and/or hospitalization due to COVID-19.
  • Use of live attenuated vaccines within 30 days of the Screening Visit.
  • Participants with Down's Syndrome.
  • History of abnormal bleeding or bruising.
  • History of solid organ transplantation.
  • Known or suspected immunodeficiency disorder, including history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency, or prolonged infections suggesting an immune compromised status, as judged by the Investigator.
  • History of alcohol or drug abuse within 6 months prior to Screening.
  • Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements, in particular with 6-minute walk test (eg, angina pectoris, claudication, musculoskeletal disorder, need for walking aids).
  • Participants with current or recent (past 30 days) lower respiratory tract infection.
  • History of malignancy in the past 5 years, with exception of completely treated in situ carcinoma of the cervix and completely treated non-metastatic squamous or basal cell carcinoma of the skin.
  • Change in PH medication (endothelin receptor agonists, phosphoesterase type 5 inhibitors, and guanylate cyclase stimulators or diuretics) between Screening and Baseline.
  • Have participated in any other interventional clinical studies within 30 days prior to Screening.
  • Current use of cigarettes (as defined by Centers for Disease Control and Prevention) or e-cigarettes.
  • Participants who currently inhale marijuana (recreational or medical).
  • Pregnant or breastfeeding.

Note: Other inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treprostinil Palmitil Inhalation Powder
Participants will be administered TPIP once per day at a starting dose of 80 micrograms (μg). Participants will be up-titrated to the highest tolerated dose for each individual participant of between 80 μg and 640 μg during the initial 3 weeks of treatment. The overall treatment period will be 16 weeks.
Drug: Treprostinil Palmitil
Administered by oral inhalation using a Plastiape capsule-based dry powder inhaler.
Other Names:
  • INS1009
Placebo Comparator: Placebo
Participants will be administered a placebo matching TPIP once per day for 16 weeks.
Drug: Placebo
Administered by oral inhalation using a Plastiape capsule-based dry powder inhaler.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Baseline in Pulmonary Vascular Resistance at Week 16
Time Frame: Baseline to Week 16
Baseline to Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from Baseline in 6-Minute Walk Test Distance at Week 5, Week 10 and Week 16
Time Frame: Baseline and Week 5, Week 10 and Week 16
Baseline and Week 5, Week 10 and Week 16
Percent Change from Baseline in 6-Minute Walk Test Distance at Week 5, Week 10 and Week 16
Time Frame: Baseline and Week 5, Week 10 and Week 16
Baseline and Week 5, Week 10 and Week 16
Number of Participants Who Experience a Treatment-emergent Adverse Event (AE)
Time Frame: Day 1 up to Week 20
Day 1 up to Week 20
Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Evaluations
Time Frame: Baseline to Week 16
Baseline to Week 16
Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurements
Time Frame: Baseline to Week 16
Baseline to Week 16
Number of Participants Who Experience a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Measurements
Time Frame: Baseline to Week 16
Baseline to Week 16
Number of Participants Who Experience a Clinically Significant Change from Baseline in Physical Examinations
Time Frame: Baseline to Week 16
Baseline to Week 16
Change from Baseline in the Concentration of N-Terminal-Pro Hormone Brain Natriuretic Peptide (NT-proBNP) Levels at Week 5, Week 10 and Week 16
Time Frame: Baseline and Week 5, Week 10 and Week 16 or end of study
Baseline and Week 5, Week 10 and Week 16 or end of study
Maximum Plasma Concentration (Cmax) of Treprostinil Palmitil
Time Frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Maximum Plasma Concentration (Cmax) of Treprostinil
Time Frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of Treprostinil Palmitil
Time Frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of Treprostinil
Time Frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to 24 Hours Post-Dose (AUC24) of Treprostinil Palmitil
Time Frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to 24 Hours Post-Dose (AUC24) of Treprostinil
Time Frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to Infinity (AUC∞) of Treprostinil Palmitil
Time Frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to Infinity (AUC∞) of Treprostinil
Time Frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to Last Measurable Concentration (AUClast) of Treprostinil Palmitil
Time Frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to Last Measurable Concentration (AUClast) of Treprostinil
Time Frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Apparent Total Clearance (CL/F) of Treprostinil Palmitil
Time Frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Apparent Total Clearance (CL/F) of Treprostinil
Time Frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Apparent Volume of Distribution After Non-Intravenous Administration (Vd/F) of Treprostinil Palmitil
Time Frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Apparent Volume of Distribution After Non-Intravenous Administration (Vd/F) of Treprostinil
Time Frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Elimination Half-Life (t1/2) of Treprostinil Palmitil
Time Frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Elimination Half-Life (t1/2) of Treprostinil
Time Frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Insmed Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 24, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 27, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 27, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INS1009-202
  • 2021-001528-16 (EudraCT Number)
  • 2023-505541-99-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings