Safety, Tolerability and Pharmacokinetics Study of L608 in Healthy Adults
ConditionHealthy Adult Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPharmosa Biopharm Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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. Subjects who have had childhood asthma which have resolved as deemed by the PI can be considered.
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 or acquired valvular heart disease with clinically insignificant symptom, suspected lung congestion, and/or pulmonary arterial hypertension (PAH) causing by venous thromboembolism.
Trial design
Treatments tested in this trial
- L608 Liposomal inhalation suspension
- Placebo Solution
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Pharmosa Biopharm Inc.
Lead sponsor
Novotech (Australia) Pty Limited
Collaborator
Source ClinicalTrials.gov