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TD-0903 Pharmacokinetics Study in Healthy Participants With Supplemental Oxygenation

NCT05091723 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-12-10

No results posted yet for this study

Summary

This is a Phase 1 pharmacokinetic (PK) study in healthy participants to assess the plasma pharmacokinetics, safety, and tolerability of a single inhaled dose of nezulcitinib (TD-0903) with supplemental oxygenation.

Conditions

  • Acute Lung Injury (ALI) Due to Coronavirus Disease-2019 (COVID-19)

Interventions

DRUG

Nezulcitinib (TD-0903) Dose A

TD-0903 Dose A

DRUG

Nezulcitinib (TD-0903) Dose B

TD-0903 Dose B

Sponsors & Collaborators

  • Theravance Biopharma

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Theravance Biopharma

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-10-13
Primary Completion
2021-11-24
Completion
2021-11-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05091723 on ClinicalTrials.gov