Clinical trial NCT04044339: Single and Multiple Ascending Dose, First-in- Human Study in Healthy Subjects
Official title: A Double-blind, Randomized, Placebo-controlled, Sponsor-open, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-5202 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: TD-5202
0177
single ascending dose
SAD
multiple ascending dose
MAD
first-in-human
Phase 1
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2019-08-05
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 ascending dose (MAD) study in healthy subjects.


Eligibility criteria: 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

Primary outcomes:
measure: To assess the safety and tolerability of SAD of TD-5202 by assessing the number, severity and type of treatment emergent adverse events
timeFrame: Day 1 through Day 8
measure: To assess the safety and tolerability of MAD of TD-5202 by assessing the number, severity and type of treatment emergent adverse events
timeFrame: Day 1 through Day 17
measure: Pharmacokinetics (PK) of TD-5202 when given as an SAD: AUC
timeFrame: Day 1 through Day 4
measure: Pharmacokinetics (PK) of TD-5202 when given as a SAD: Cmax
timeFrame: Day 1 through Day 4
measure: Pharmacokinetics (PK) of TD-5202 when given as a SAD: Tmax
timeFrame: Day 1 through Day 4
measure: PK of TD-5202 when given as an SAD: CL/F
timeFrame: Day 1 through Day 4
measure: PK of TD-5202 when given as an SAD: Vz/F
timeFrame: Day 1 through Day 4
measure: PK of TD-5202 when given as an SAD: Kel
timeFrame: Day 1 through Day 4
measure: PK of TD-5202 when given as an SAD: t 1/2
timeFrame: Day 1 through Day 4
measure: PK of TD-5202 when given as an MAD: AUC
timeFrame: Day 1 and Day 10
measure: PK of TD-5202 when given as an MAD: Cmax
timeFrame: Day 1 and Day 10
measure: PK of TD-5202 when given as an MAD: Tmax
timeFrame: Day 1 and Day 10
measure: PK of TD-5202 when given as an MAD: C trough
timeFrame: Day 2, 4, 6, 8
measure: PK of TD-5202 when given as an MAD: Css
timeFrame: Day 10
measure: PK of TD-5202 when given as an MAD: CL/Fss
timeFrame: Day 10
measure: PK of TD-5202 when given as an MAD: Cmin
timeFrame: Day 10
measure: PK of TD-5202 when given as an MAD: Vz/Fss
timeFrame: Day 10
measure: PK of TD-5202 when given as an MAD: Kel
timeFrame: Day 10
measure: PK of TD-5202 when given as an MAD: t 1/2
timeFrame: Day 10
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Theravance Biopharma Investigational Site
state: Nebraska
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References: