Status:
COMPLETED
Single and Multiple Ascending Dose, First-in- Human Study in Healthy Subjects
Lead Sponsor:
Theravance Biopharma
Conditions:
Healthy
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief Summary
This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 2 parts: Part A is a single ascending dose (SAD) study in healthy subjects and Part B is a multiple ascen...
Eligibility Criteria
Inclusion
- Male or female, 19 - 55 years old
- Willing and able to give informed consent and comply with the study
- Medically healthy with no clinically significant medical history
- Body mass index (BMI) 18 to 32 kg/m2 and weighs at least 50 kg
- Women of child bearing potential must have a negative pregnancy test and use a highly efficient birth control method
- Males must use acceptable contraception
- Additional inclusion criteria apply
Exclusion
- Positive for hepatitis A, B or C, HIV or tuberculosis
- Clinically significant abnormalities of laboratory evaluations
- Have abnormal ECG or vital sign measurements
- Any acute illness at time of screening
- Have a current bacterial, parasitic, fungal or viral infection
- Uses or have used tobacco or nicotine-containing products within 6 months prior to screening
- Additional inclusion criteria apply
Key Trial Info
Start Date :
August 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2019
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04044339
Start Date
August 8 2019
End Date
November 27 2019
Last Update
January 14 2021
Active Locations (1)
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1
Theravance Biopharma Investigational Site
Lincoln, Nebraska, United States, 68502