Safety, Tolerability and Pharmacokinetics of L608 in Healthy Adults (NCT05938946) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability and Pharmacokinetics of L608 in Healthy Adults
Australia64 participantsStarted 2023-08-30
Plain-language summary
This is a Phase I, randomized, double-blinded, placebo-controlled single ascending dose, sequential-group study to evaluate the safety, tolerability, and PK of single ascending doses of L608 inhalation in healthy volunteers.
Who can participate
Age range18 Years ā 65 Years
SexALL
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Inclusion criteria
ā. Men and women aged between 18 and 65 (inclusive) at the time of Screening visit. Females must not be pregnant or lactating.
ā. Body Mass Index (BMI) of ā„18.5 and ā¤30.0 kg/m2
ā. Non-smokers or former smokers who have smoked ā¤ 100 cigarettes in their lifetime and have not consumed any tobacco or tobacco-containing products for at least 3 months prior to Screening.
ā. 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.
Exclusion criteria
ā. Subjects with contraindications or sensitivity to any components of the study treatment.
ā. Subjects with medical histories (within 3 months prior to Screening) or ongoing conditions of any clinically significant and/or any other medical conditions which may jeopardize the safety of the subjects and/or effect the results of the study at the Investigator's discretion.
ā. Subjects with histories or active conditions of unexplained bleeding events, hemoptysis, abnormal bleeding tendencies, and/or coagulation disorders.
ā. Subjects who voluntarily participate in this study and sign the informed consent form prior to any study procedures.
ā. Subjects with histories or active conditions of asthma, sleep apnea, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, bronchiectasis, bronchospasm, and/or reactive airway. Subjects who have had childhood asthma which have resolved as deemed by the PI can be considered.
What they're measuring
1
The incidence of dose limiting toxicity (DLT)
Timeframe: Baseline to Day 14
2
The incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Timeframe: Baseline to Day 21
3
Frequency and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)