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A Dose Escalation Phase 1 Study Evaluating the Safety and Pharmacokinetics of an Inhaled COVID-19 Inhibitor Delcetravir in Healthy Subjects

NCT05453279 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-07-12

No results posted yet for this study

Summary

This study will be a single center, Phase I, randomized, double-blind, placebo controlled, single and multiple ascending dose (SAD/MAD) study evaluating the safety, tolerability, and PK of Delcetravir after administration via oral inhalation in healthy subjects.

Conditions

Interventions

COMBINATION_PRODUCT

Delcetravir dry powder inhaler

Placebo dry powder inhaler

Sponsors & Collaborators

  • Esfam Biotech Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Albert G Frauman, MD · Esfam Biotech Pty Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2022-11-01
Completion
2023-01-01

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05453279 on ClinicalTrials.gov