Can a new inhaled powder pass its first safety test?
NCT ID NCT07804628
First seen Sep 04, 2026 · Last updated Sep 04, 2026
Summary
Researchers are testing an inhaled dry powder called ICF001 in healthy adults aged 18 to 55. The study gives single and repeated doses to see if the drug is safe, how well people tolerate it, and how it moves through the body. Participants receive either ICF001 or a placebo, and the team monitors side effects, lung function, and other health measures. This early phase 1 trial focuses on safety, not on treating any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ICF001, an inhaled dry powder delivered via capsules
- What this could lead to
- If ICF001 proves safe and well-tolerated, it could move into later trials as a potential treatment for lung or respiratory conditions.
- What could go wrong
- This is an early, small phase 1 study in healthy people, so it cannot show whether ICF001 works for any disease. The drug may cause side effects or fail in later trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Understand the study procedures and methods, voluntarily participate in this study, and provide written informed consent. * Healthy adult participants aged 18 to 55 years (inclusive), both genders. * Body Mass Index (BMI) equal to (=) weight/height squared kilogram per meter square (kg/m\^2)): 18 less than or equal to (\<=) BMI \<=32; male weight greater than or equal to (\>=) 50.0 kilogram (kg) and less than (\<) 100.0 kg, female weight \>=45.0 kg and \<100.0 kg. * Confirmed to have no clinically significant abnormalities through physical examination, laboratory tests, vital signs assessment, and electrocardiogram (ECG), and determined by the investigator to be medically healthy. * Participants whose peak inspiratory flow rate measured by In-Check\^TM DIAL G16 is between 30 to 60 liters per minute (L/min) and whose total inspiratory duration exceeds 2 seconds. * Participants must be able to correctly and effectively use the inhaler device during the screening period and throughout the study. * Sexually active female participants of childbearing potential must agree to use effective contraception from screening until 35 days after the last dose and must not become pregnant or donate eggs during this period; Sexually active male participants with partners of childbearing potential must agree to use effective contraception from the first dose until 95 days after the last dose and must not donate sperm during this time; their fertile male or female partners must also agree to use effective contraception during this period. * Ability to successfully complete test dosing procedure following inhalation training on Day-1. * Able to understand the study procedures and provide signed informed consent to participate in the study. Exclusion Criteria: * Participants with a history of any clinically significant disease (including both past and current medical conditions), including but not limited to respiratory, cardiovascular, neurological, gastrointestinal, hematologic, endocrine, immune, dermatologic, malignancy, neuropsychiatric, ophthalmologic, or metabolic disorders, or any other condition that, in the opinion of the investigator (or designee), would make the participant unsuitable for participation in the study. A history of bariatric surgery or prior cholecystectomy; a history of eczema (provided no use of topical or systemic steroid treatments within 3 months prior to screening); a history of gestational diabetes that has fully resolved; current or past attention deficit hyperactivity disorder (ADHD), anxiety, or depression (provided no use of antidepressant medication within 6 months prior to screening); and Gilbert's syndrome are not considered exclusionary, provided they are not currently clinically significant and are acceptable at the investigator's discretion. * Participants who have undergone any major surgery within 3 months, or any minor surgery within 1 months prior to dosing, or who plan to undergo surgery during the study, or who have undergone surgery that may significantly affect the pharmacokinetic (PK) or safety evaluation of the study drug. * Participants with clinically significant oral diseases that, in the investigator's judgment, may affect the study (e.g., oral candidiasis, oral ulcers, lesions of the oral mucosa, etc.). * Participants with clinically significant nasal diseases such as severe rhinitis, sinusitis, nose cavity and nose septum infections and lesions. * Risk of bleeding: History of bleeding disorders, active peptic ulcer, or history of gastrointestinal bleeding; abnormal platelet count, international normalized ratio (INR), or activated partial thromboplastin Time (APTT) during the screening period. * History of asthma, chronic obstructive pulmonary disease (COPD), or reactive airway disease, or pulmonary function test findings consistent with asthma or COPD. * History of orthostatic hypotension, unexplained syncope, or hypertension. * During screening or re-screening, participants with a systolic blood pressure of \<90 millimeters of mercury (mmHg) or a diastolic blood pressure of \<50 mmHg after sitting for 5 minutes. * During screening or re-screening, participants with a systolic blood pressure of greater than (\>) 140 mmHg or a diastolic blood pressure of \>90 mmHg after sitting for 5 minutes. * During screening or re-screening, participants with a heart rate of \>100 beats/minute after sitting for 5 minutes. * Participants with a fever (temperature \>37.5 degrees Celsius \[°C\]) or symptomatic respiratory infection within 1 month prior to dosing, or those with any infection requiring systemic antibiotics/antiviral medications within 3 months prior to screening, or those with a history of recurrent infections. * Positive for Human Immunodeficiency Virus (HIV), hepatitis B surface antigen, and hepatitis C. * During screening/baseline visit, participants with alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transferase (GGT), or total bilirubin \>=1.5 the upper limit of normal (ULN). * Screening/Baseline Visit: Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) \<80 percentage (%) of predicted value, or FEV1/FVC \< 0.7, or an oxygen saturation (SpO₂) \<95%. Spirometry may be repeated at the same visit for a total of 3 tests if initial results are considered unacceptable due to poor effort or technical issues, with the best value recorded. * Participants who smoked (including vaping) within 3 months prior to dosing, or with positive cotinine test results. * Participants with potential risk of airway hyperreactivity, such as those with prolonged exposure to dust or harmful gases. * Participants with a history of heavy alcohol consumption within 3 months prior to screening, defined as \>14 alcohol units per week for males and \>10 alcohol units per week for females (where 1 standard unit =375 milliliter (mL) of mid-strength beer (3.5% alcohol/volume), 100 mL of wine (13.5% alcohol/volume), or 30 mL of spirits (40% alcohol/volume)), or with a positive breath alcohol test, or who are unable to abstain from alcohol during the study period. * Participants who have received any known moderate or strong inhibitors/inducers of cytochrome P450 (CYP) enzymes (for example; barbiturates, phenothiazines, cimetidine, carbamazepine) within the 30 days prior to the study, and for whom the investigator believes that these medications may affect the participant's safety or the validity of the study results. * Participants with a history of drug abuse within 3 months prior to screening, or those with a positive urine drug screen. * Participants who have participated in any clinical trials of drugs or medical devices within 5 half-lives or 3 months after the last dose/administration, whichever is longer, prior to screening. * Participants who have donated or lost \>=400 mL of blood within 30 days prior to dosing. * Participants with difficulty in intravenous blood collection or intolerance to venipuncture, or those with a history of vasovagal syncope. * Participants who have used any medication (including prescription drugs, over-the-counter drugs, vitamin supplements, or traditional medicines, especially anticoagulants, antiplatelet agents, non-steroidal anti-inflammatory drugs, vasodilators, or potent CYP2C8 inhibitors such as gemfibrozil and rifampin) or received any health supplements or vaccines within 7 days prior to dosing (or 5 half-lives of the drug, whichever is longer). * Participants who have consumed foods that may affect drug metabolism within 7 days prior to dosing (including grapefruit or grapefruit products, pitaya, mango, pomelo, etc.), or those with other dietary habits that the investigator believes may affect the absorption, distribution, metabolism, or excretion of the drug, or those who are unwilling to discontinue consuming the aforementioned foods during the study period. * Participants who have consumed any coffee or tea, as well as beverages and foods containing coffee or tea ingredients, within 48 hours prior to dosing, or those who are unwilling to discontinue consuming these foods during confinement, and within 24 hours before each follow-up visit. * Participants with special dietary requirements who cannot comply with a standard diet. * Participants with a known allergy to the study drug or any of its components. * Female participants who are pregnant or breastfeeding, or who have plans to become pregnant during the study period or within 2 months after the last dose. * Participants are deemed by the investigator to be unsuitable for participation in the study.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Q-Pharm Pty Ltd
Brisbane, Queensland, 4006, Australia
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