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

Theravance Biopharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: TD-5202

Study type: Interventional

Funder types: Industry

Identifiers

NCT04044339

0177

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

56 participants in 4 patient groups, including a placebo group

TD-5202 for SAD (Part A)

Experimental group

Description:

6 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive TD-5202

Treatment:

Drug: TD-5202

Placebo for SAD (Part A)

Placebo Comparator group

Description:

2 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive placebo

Treatment:

Drug: Placebo

TD-5202 for MAD (Part B)

Experimental group

Description:

6 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-5202

Treatment:

Drug: TD-5202

Placebo for MAD (Part B)

Placebo Comparator group

Description:

2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo.

Treatment:

Drug: Placebo