First in Human SAD and MAD Study of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19
- Conditions
- Inflammatory Lung Conditions Associated With COVID-19Acute Lung Injury (ALI) Associated With COVID-19
- Interventions
- Drug: Placebo
- Registration Number
- NCT04350736
- Lead Sponsor
- Theravance Biopharma
- Brief Summary
This is a phase 1 study in healthy subjects to evaluate the safety, tolerability and pharmacokinetics of single (Part A and B) and multiple (Part B) doses of inhaled TD-0903.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening and weighs at least 50 kg.
- Medically healthy with no clinically significant medical history, physical examination, spirometry, vital signs or ECGs.
- Forced expiratory volume in 1 second (FEV1) ≥80%.
- No clinically significant abnormalities in the results of laboratory evaluations.
- 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, in addition to the use of highly effective pregnancy prevention measures with female partners of childbearing potential.
- Understands the correct technique for the use the nebulizer device(s).
- Other inclusion criteria apply
- 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.
- Subject who has a current bacterial, parasitic, fungal, or viral infection; any infection requiring hospitalization or intravenous antibiotics within 6 months prior to Screening.
- Positive test for SARS-CoV-2
- Subject has any condition of the oro-laryngeal or respiratory tract.
- Uses or has used tobacco or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, patches etc.) within 6 months prior to screening
- Additional exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo for SAD (Part A) Placebo 2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo Placebo for MAD (Part B) Placebo 2 out of 10 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo TD-0903 for SAD (Part A) TD-0903 6 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-0903 TD-0903 for MAD (Part B) TD-0903 8 out of 10 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-0903
- Primary Outcome Measures
Name Time Method Safety and Tolerability of SAD of TD-0903: Adverse Events Day 1 to Day 8 Number and severity of treatment emergent adverse events
Safety and Tolerability of MAD of TD-0903: Adverse Events Day 1 to Day 14 Number and severity of treatment emergent adverse events
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): AUC Day 1 through Day 4 Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Area under the plasma concentration-time curve (AUC)
Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): AUC Day 1 through Day 9 Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Area under the plasma concentration-time curve (AUC)
Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Tmax Day 1 through Day 4 Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Time to reach maximum observed concentration (Tmax)
Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Cmax Day 1 through Day 4 Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Maximum observed concentration (Cmax)
Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Cmax Day 1 through Day 9 Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Maximum observed concentration (Cmax)
Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Tmax Day 1 through Day 9 Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Time to reach maximum observed concentration (Tmax)
Trial Locations
- Locations (1)
Theravance Biopharma Investigational Site
🇬🇧Manchester, United Kingdom