Safety, Tolerability, & Pharmacokinetics Study of Single & Multiple Inhaled Doses of Imatinib Inhalation Solution

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    78
  • sponsor
    Aerami Therapeutics
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Updated on 23 March 2022
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Accepts healthy volunteers

Summary

This is a randomised, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and PK of single and multiple inhaled doses of imatinib inhalation solution (AER-901) in healthy adult volunteers. This study consists of 2 parts and an optional third part:

  • Part A: double-blind, placebo-controlled, single ascending dose (SAD).
  • Part B: double-blind, placebo-controlled, multiple-ascending dose (MAD).
  • Part C (optional): an open-label, single-dose, 2-way crossover. Each part of the study will include a 28-day screening period, a treatment period, and follow-up period.

Description

This is a randomised, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and PK of single and multiple inhaled doses of imatinib inhalation solution (AER-901) in healthy adult volunteers. This study consists of 2 parts and an optional third part:

  • Part A: double-blind, placebo-controlled, single ascending dose (SAD).
  • Part B: double-blind, placebo-controlled, multiple-ascending dose (MAD).
  • Part C (optional): an open-label, single-dose, 2-way crossover.

The decision to proceed with Part C will be made by the Sponsor after reviewing unblinded safety and PK data from Part A and Part B of the study.

Oversight for the study will be provided by a safety review committee (SRC). The decision to progress from Cohort A1 to Cohort A2 will be based on safety and tolerability data from Cohort A1. The decision to progress from Cohort A2 to Cohort A3 will be based on review of safety and tolerability data from Cohort A2 and PK data from Cohort A1 by the SRC. A similar sequence will follow for subsequent progression decisions by the SRC for all the cohorts in Part A and Part B of the study.

Each part of the study will include a 28-day screening period, a treatment period, and follow-up period.

Details
Condition Pulmonary Arterial Hypertension
Treatment Placebo, AER-901 Solution for Nebulization
Clinical Study IdentifierNCT04903730
SponsorAerami Therapeutics
Last Modified on23 March 2022

Eligibility

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Inclusion Criteria

Provide written consent
Body weight ≥ 50 kg, and a body mass index 18.0 to 32.0, inclusive
Female participants of non child bearing potential or if of child bearing potential, agrees to take effective contraceptive measures throughout the study period
Male participant: has undergone bilateral vasectomy or agrees to use effective contraceptive effective contraceptive measures or abstinence, and not donate sperm throughout the study until at least 3 months after the last dose of IP
Forced expiratory volume in 1 sec (FEV1)/forced vital capacity (FVC) ratio of at least 0.7
Values for FEV1 and FVC of at least 80% of the predicted value
Able to understand the nature of the study and any hazards of participation, and ability to communicate satisfactorily with the Investigator and to participate in, and comply with the requirements of, the entire study
Able to successfully perform spirometry and use the inhalation device at Screening
Negative result for cotinine in the urine drug screen, at Screening and on Day -1

Exclusion Criteria

Clinically significant physical findings, vital signs, ECG, or laboratory values that could interfere with the objectives of the study or the safety of the subject
Pregnant or lactating or planning to become pregnant (self or partner) at any time during the study, including the follow-up period
Presence of acute or chronic illness or history of chronic illness
Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary artery disease, or history of any psychotic mental illness
Upper or lower respiratory tract infection within 4 weeks before the first dose of treatment
Any medically identified respiratory disease(s) and/or condition(s), including but not limited to current asthma, chronic obstructive pulmonary disease, and diagnosed obstructive sleep apnoea syndrome
Any clinically significant arrhythmia(s) at Screening ECG
History of surgery or medical intervention, or planned surgery or medical intervention, that could interfere with the objectives of the study or the safety of the volunteer
Currently taking any drug including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days before the first dose and throughout the study, with the exception of acetylsalicylic acid (aspirin)
Positive test result(s) for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HbsAg), human immunodeficiency virus (HIV) antibody, or coronavirus disease of 2019 (COVID-19)
Suffering from post-COVID-19 syndrome or have tested positive for COVID-19 infection within 3 months prior to the first dose of treatment
Participation in another clinical study of a new chemical entity, new device, or a prescription medicine within 3 months before dosing
Regular alcohol consumption at levels which may increase risk of harm from alcohol-related disease or injury. Participant is unwilling to abstain from alcohol beginning 48 hours prior to admission to the CRU and for the duration of the study
A history of substance abuse or dependency in the last 12 months, or a history of recreational intravenous drug use over the last 5 years, or a positive toxicology screening panel (urine test including qualitative identification of barbiturates, THC, amphetamines, methamphetamines, MDMA, phencyclidine, benzodiazepines, opiates and cocaine), or alcohol breath test
Current or previous use of tobacco, nicotine products, vaping device or e-cigarettes within the past 6 months
Loss of more than 400 mL blood (e.g., as a blood donor, or donor of blood products), during the 3 months before screening
Received any vaccination (e.g. for COVID-19 or influenza) within 6 weeks of treatment or plans to receive a vaccination during the study
History of Mycobacterium tuberculosis infection, or latent M. tuberculosis infection
Active or latent parasitic infection, have travelled to or have an intention to travel to a country with a high prevalence of parasitic infections within 3 months before or after receiving the treatment
Evidence of any other clinically significant infection, including bacterial or viral infections, at Screening and Day -1
Presence of any underlying physical and/or psychological medical condition that would make it unlikely that the participant will comply with the protocol or complete the study per protocol
An employee of the study site or Sponsor who is directly involved in the study, or a family member of such a person
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