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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Theravance Biopharma
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- PK of TD-5202 when given as an SAD: Vz/F
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
TD-5202 for SAD (Part A)
6 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive TD-5202
Intervention: TD-5202 (Drug)
Placebo for SAD (Part A)
2 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive placebo
Intervention: Placebo (Drug)
TD-5202 for MAD (Part B)
6 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-5202
Intervention: TD-5202 (Drug)
Placebo for MAD (Part B)
2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
PK of TD-5202 when given as an SAD: Vz/F
Time Frame: Day 1 through Day 4
Terminal Phase Volume of Distribution(Vz/F)
PK of TD-5202 when given as an SAD: Kel
Time Frame: Day 1 through Day 4
Elimination Rate (Kel)
PK of TD-5202 when given as an SAD: t 1/2
Time Frame: Day 1 through Day 4
Halflife (t 1/2)
PK of TD-5202 when given as an MAD: AUC
Time Frame: Day 1 and Day 10
Area under the plasma concentration-time curve (AUC)
PK of TD-5202 when given as an MAD: Cmax
Time Frame: Day 1 and Day 10
Maximum observed concentration (Cmax)
PK of TD-5202 when given as an MAD: Tmax
Time Frame: Day 1 and Day 10
Time to reach maximum observed concentration (Tmax)
PK of TD-5202 when given as an MAD: C trough
Time Frame: Day 2, 4, 6, 8
concentration at trough (after multiple dosing usually after reaching steady state) (C trough)
PK of TD-5202 when given as an MAD: Css
Time Frame: Day 10
concentration at steady state (Css)
PK of TD-5202 when given as an MAD: CL/Fss
Time Frame: Day 10
Oral clearance at steady state (CL/Fss)
PK of TD-5202 when given as an MAD: Cmin
Time Frame: Day 10
Concentration minimum (after single dosing) (Cmin)
To assess the safety and tolerability of SAD of TD-5202 by assessing the number, severity and type of treatment emergent adverse events
Time Frame: Day 1 through Day 8
To assess the safety and tolerability of MAD of TD-5202 by assessing the number, severity and type of treatment emergent adverse events
Time Frame: Day 1 through Day 17
Pharmacokinetics (PK) of TD-5202 when given as an SAD: AUC
Time Frame: Day 1 through Day 4
Area under the plasma concentration-time curve (AUC)
Pharmacokinetics (PK) of TD-5202 when given as a SAD: Cmax
Time Frame: Day 1 through Day 4
Maximum observed concentration (Cmax)
Pharmacokinetics (PK) of TD-5202 when given as a SAD: Tmax
Time Frame: Day 1 through Day 4
Time to reach maximum observed concentration (Tmax)
PK of TD-5202 when given as an SAD: CL/F
Time Frame: Day 1 through Day 4
Oral Clearance (CL/F)
PK of TD-5202 when given as an MAD: t 1/2
Time Frame: Day 10
Halflife (t 1/2)
PK of TD-5202 when given as an MAD: Vz/Fss
Time Frame: Day 10
Terminal phase volume of distribution at steady state (Vz/Fss)
PK of TD-5202 when given as an MAD: Kel
Time Frame: Day 10
Elimination Rate (Kel)
Secondary Outcomes
No secondary outcomes reported