Single and Multiple Ascending Dose, First-in- Human Study in Healthy Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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 ascending dose (MAD) study in healthy subjects.

Key facts

Study ID

NCT04044339

Run by

Theravance Biopharma

People needed

56

Starts

2019-08-08

Expected to finish

2019-11-27

Last updated by the study team

2021-01-14

Who can join

Age: 19 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Theravance Biopharma Investigational Site — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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