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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04350736
Other study ID # 0183
Secondary ID 2020-000577-24
Status Completed
Phase Phase 1
First received
Last updated
Start date April 23, 2020
Est. completion date July 1, 2020

Study information

Verified date June 2021
Source Theravance Biopharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date July 1, 2020
Est. primary completion date June 24, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - 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 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. - 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


Intervention

Drug:
TD-0903
Study drug to be administered by inhalation
Placebo
Placebo to be administered by inhalation

Locations

Country Name City State
United Kingdom Theravance Biopharma Investigational Site Manchester

Sponsors (1)

Lead Sponsor Collaborator
Theravance Biopharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and Tolerability of SAD of TD-0903: Adverse Events Number and severity of treatment emergent adverse events Day 1 to Day 8
Primary Safety and Tolerability of MAD of TD-0903: Adverse Events Number and severity of treatment emergent adverse events Day 1 to Day 14
Secondary Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): AUC 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) Day 1 through Day 4
Secondary Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Cmax Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Maximum observed concentration (Cmax) Day 1 through Day 4
Secondary Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Tmax 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) Day 1 through Day 4
Secondary Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): AUC 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) Day 1 through Day 9
Secondary Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Cmax Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Maximum observed concentration (Cmax) Day 1 through Day 9
Secondary Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Tmax 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) Day 1 through Day 9
See also
  Status Clinical Trial Phase
Completed NCT04402866 - TD-0903 for ALI Associated With COVID-19 Phase 2