TD-0903 Pharmacokinetics Study in Healthy Participants With Supplemental Oxygenation

NCT ID: NCT05091723

Last Updated: 2021-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-13
• Study Completion Date: 2021-11-24

Brief 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.

Detailed Description

A Phase 1, open-label, fixed-sequence, 4-period study to evaluate the plasma PK, safety and tolerability of single inhaled doses of nezulcitinib (TD-0903) administered under different supplemental oxygenation scenarios in healthy participants.

Approximately 14 healthy adult male and female participants will receive a single inhaled dose of nezulcitinib using a nebulizer device on Day 1 of each administration period, under different supplementary oxygenations conditions.

Administration A: Dose A nezulcitinib delivered by nasal inhalation via the Aerogen Solo with a high-flow nasal cannula circuit delivering supplemental oxygen, Administration B: Dose A nezulcitinib delivered by oral inhalation via the Aerogen Solo together with the Aerogen Ultra handheld device with a low-flow nasal cannula delivering supplemental oxygen, Administration C: Dose A nezulcitinib delivered by oral inhalation via the Aerogen Solo together with the Aerogen Ultra handheld device with a high-flow nasal cannula delivering supplemental oxygen, Administration D: Nezulcitinib delivered by inhalation. Route to be determined based on data from administration A-C.

Conditions

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

Keywords

Acute lung injury; ALI; Coronavirus Disease-2019; COVID-19; Supplemental oxygen

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Administration Scenario A

Single dose of TD-0903 at Dose A on Day 1, Period 1 delivered by nasal inhalation via nebulizer device with a high-flow nasal cannula delivering supplemental oxygen

Group Type: EXPERIMENTAL

Nezulcitinib (TD-0903) Dose A

Intervention Type: DRUG

TD-0903 Dose A

Administration Scenario B

Single dose of TD-0903 at Dose A on Day 1, Period 2 delivered by oral inhalation via nebulizer device with supplemental oxygen delivery via low-flow nasal cannula

Group Type: EXPERIMENTAL

Nezulcitinib (TD-0903) Dose A

Intervention Type: DRUG

TD-0903 Dose A

Administration Scenario C

Single dose of TD-0903 at Dose A on Day 1, Period 3 delivered by oral inhalation via nebulizer device with supplemental oxygen delivery via high-flow nasal cannula

Group Type: EXPERIMENTAL

Nezulcitinib (TD-0903) Dose A

Intervention Type: DRUG

TD-0903 Dose A

Administration Scenario D

Single dose of TD-0903 at Dose B on Day 1, Period 4 delivered by a route to-be-determined based on data from Scenarios A, B and C.

Group Type: EXPERIMENTAL

Nezulcitinib (TD-0903) Dose B

Intervention Type: DRUG

TD-0903 Dose B

Interventions

Nezulcitinib (TD-0903) Dose A

TD-0903 Dose A

Intervention Type: DRUG

Nezulcitinib (TD-0903) Dose B

TD-0903 Dose B

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body mass index (BMI) ≥ 18.0 and ≤ 35.0 kg/m2 and weighs at least 50 kg at screening
• Medically healthy with no clinically significant medical history, physical examination, spirometry, laboratory profiles, vital signs or ECGs
• Forced expiratory volume of 1 second (FEV1) ≥80% predicted at screening and prior to dosing
• No clinically significant abnormalities in the results of laboratory
• Female subjects must be either of non-childbearing potential or if of childbearing potential, subject must not be pregnant or breastfeeding, and must agree to use a highly effective birth control method
• Male subjects must agree to use condoms to prevent potential fetal or partner exposure through seminal fluid, in addition to the use of highly effective pregnancy prevention measures with female partners of childbearing potential
• Able to understand the correct technique for the use of the nebulizer device

Exclusion Criteria

• History or presence of clinically significant medical or psychiatric condition
• Abnormal ECG measurements at screening
• Any signs of respiratory tract infection within 6 weeks of screening
• Has a current bacterial, parasitic, fungal, or viral infection; any infection requiring hospitalization or intravenous antibiotics within 6 months prior to screening
• Has any condition of the oro-laryngeal or respiratory tract
• History or presence of alcoholism or drug abuse
• Positive urine drugs of abuse test
• Positive urine or breath alcohol results
• Uses or has used tobacco or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, patches etc.) within 6 months prior to screening
• Tests positive for active COVID-19

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Theravance Biopharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Theravance Biopharma

Locations

Theravance Biopharma Investigational Site

Cypress, California, United States

Countries

United States

Other Identifiers

0196

Identifier Type: -

Identifier Source: org_study_id