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Safety, Tolerability and Pharmacokinetics of L608 in Healthy Adults - Trial NCT05938946

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.

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NCT05938946
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05938946
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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

Study Focus

L608 Inhalation Solution

Interventional

drug

Sponsor & Location

Pharmosa Biopharm Inc.

Adelaide, Australia

Timeline & Enrollment

Phase 1

Jul 31, 2023

Jun 30, 2024

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 hypertension
Other secondary pulmonary hypertension
Pulmonary heart disease and diseases of pulmonary circulation
Stenosis of pulmonary artery
Pulmonary heart disease, unspecified

Data Source

ClinicalTrials.gov

NCT05938946

Non-Device Trial