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Tests treatment safety and results for Healthy Adult Participants
Official title Safety, Tolerability and Pharmacokinetics Study of L608 in Healthy Adults
ClinicalTrials.gov ID: NCT06429930
What this study is testing
What is L608 Liposomal inhalation suspension?
L608 Liposomal inhalation suspension is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for healthy adult participants.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single ascending dose study of L608 in healthy participants and is being conducted to evaluate the safety of L608 with dose level ranging from 10 μg to 20 μg.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Men and women aged between 18 and 65 (inclusive) at the time of Screening visit.
- Participants with Body Mass Index (BMI) of ≥18.5 and ≤32.0 kg/m2 and weight of at least 50 kg at Screening.
- Non-smokers or former smokers who have smoked ≤ 100 cigarettes in their lifetime and have not consumed any tobacco or tobacco-containing products for...
- Females must not be pregnant or lactating and must use acceptable, highly effective double contraception from Screening until 3 months after the last...
You likely can't join if
- Participants with contraindications or sensitivity to any components of the study treatment.
- Participants with histories or active conditions of unexplained bleeding events, hemoptysis, abnormal bleeding tendencies, and/or coagulation...
- Participants with histories or active conditions of asthma, sleep apnea, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis...
- Participants with histories or active conditions of myocardial infarction (MI), cerebrovascular accident (CVA), coronary artery disease (CAD)...
- Cohorts A1 and B1: Participants with systolic blood pressure \ 140 mmHg and/or diastolic blood pressure \ 95 mmHg at Screening or check-in visit...
- Participants with FEV1 less than 80% predicted, FVC ˂ 80% predicted, or resting oxygen saturation less than 95% at Screening or check-in visit.
See the full eligibility criteria
- Men and women aged between 18 and 65 (inclusive) at the time of Screening visit.
- Participants with Body Mass Index (BMI) of ≥18.5 and ≤32.0 kg/m2 and weight of at least 50 kg at Screening.
- Non-smokers or former smokers who have smoked ≤ 100 cigarettes in their lifetime and have not consumed any tobacco or tobacco-containing products for at least 3 months prior to Screening.
- Females must not be pregnant or lactating and must use acceptable, highly effective double contraception from Screening until 3 months after the last dose of the Investigational product. Key
- Participants with contraindications or sensitivity to any components of the study treatment.
- Participants with histories or active conditions of unexplained bleeding events, hemoptysis, abnormal bleeding tendencies, and/or coagulation disorders.
- Participants with histories or active conditions of asthma, sleep apnea, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, bronchiectasis, bronchospasm, and/or reactive airway. people who have had...
- Participants with histories or active conditions of myocardial infarction (MI), cerebrovascular accident (CVA), coronary artery disease (CAD), unstable angina, heart failure, significant cardiac arrhythmias, congenital...
- Cohorts A1 and B1: Participants with systolic blood pressure \ 140 mmHg and/or diastolic blood pressure \ 95 mmHg at Screening or check-in visit. Cohorts B2, B3, C1 and C2: Participants with systolic blood pressure \...
- Participants with FEV1 less than 80% predicted, FVC ˂ 80% predicted, or resting oxygen saturation less than 95% at Screening or check-in visit.
- Participants with histories of drug or alcohol abuse within 1 year prior to subject check-in (Day -1). Regular alcohol consumption defined as \> 14 standard drinks per week for female and \> 21 standard drinks per week...
- Consumption of products containing caffeine/methylxanthines, poppy seeds and/or alcohol within 48 hours before dosing and products containing grapefruit and/or pomelo (shown to inhibit cytochrome P450 [CYP] 3A4...
- Receipt of blood products within 2 months prior to dosing.
- Positive results of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and pregnancy test.
- Blood donation or significant blood loss (\>480 ml) within 3 months prior to Screening.
- Participants unwilling to refrain from strenuous exercises from 7 days prior to dosing until the EOS visit.
- Participants planning to receive a tattoo, body piercing, or undergo any invasive procedure during the study period.
The study team makes the final eligibility decision.
Where it's taking place
- Christchurch, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Christchurch, New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.