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NCT05938946Not yet recruiting

Safety, Tolerability and Pharmacokinetics of L608 in Healthy Adults

A Phase I, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of L608 for Inhalation in Healthy Subjects
Pharmosa Biopharm Inc.Phase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Pulmonary Arterial Hypertension
Drug/Device/Intervention
L608 Inhalation Solution
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Pharmosa Biopharm Inc.
Location
Adelaide, Australia
Timeline & enrollment
Phase
Phase 1
Start date
Jul 31, 2023
End date
Jun 30, 2024
Enrollment
64 participants
Primary outcome

The incidence of dose limiting toxicity (DLT),The incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs),Frequency and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

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.

ICD-10 classifications
Primary pulmonary hypertensionOther secondary pulmonary hypertensionPulmonary heart disease and diseases of pulmonary circulationStenosis of pulmonary arteryPulmonary heart disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05938946
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05938946 through Pure Global AI's free database. This Phase 1 trial is sponsored by Pharmosa Biopharm Inc. and is currently Not yet recruiting. The study focuses on Pulmonary Arterial Hypertension. Target enrollment is 64 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.