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

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: TD-5202; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Theravance Biopharma Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TD-5202 for SAD (Part A); 6 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive TD-5202	Drug: TD-5202; Study Drug to be administered orally
Placebo Comparator: Placebo for SAD (Part A); 2 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive placebo	Drug: Placebo; Placebo to be administered orally
Experimental: TD-5202 for MAD (Part B); 6 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-5202	Drug: TD-5202; Study Drug to be administered orally
Placebo Comparator: Placebo for MAD (Part B); 2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo.	Drug: Placebo; Placebo to be administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the safety and tolerability of SAD of TD-5202 by assessing the number, severity and type of treatment emergent adverse events		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		Day 1 through Day 17
Pharmacokinetics (PK) of TD-5202 when given as an SAD: AUC	Area under the plasma concentration-time curve (AUC)	Day 1 through Day 4
Pharmacokinetics (PK) of TD-5202 when given as a SAD: Cmax	Maximum observed concentration (Cmax)	Day 1 through Day 4
Pharmacokinetics (PK) of TD-5202 when given as a SAD: Tmax	Time to reach maximum observed concentration (Tmax)	Day 1 through Day 4
PK of TD-5202 when given as an SAD: CL/F	Oral Clearance (CL/F)	Day 1 through Day 4
PK of TD-5202 when given as an SAD: Vz/F	Terminal Phase Volume of Distribution(Vz/F)	Day 1 through Day 4
PK of TD-5202 when given as an SAD: Kel	Elimination Rate (Kel)	Day 1 through Day 4
PK of TD-5202 when given as an SAD: t 1/2	Halflife (t 1/2)	Day 1 through Day 4
PK of TD-5202 when given as an MAD: AUC	Area under the plasma concentration-time curve (AUC)	Day 1 and Day 10
PK of TD-5202 when given as an MAD: Cmax	Maximum observed concentration (Cmax)	Day 1 and Day 10
PK of TD-5202 when given as an MAD: Tmax	Time to reach maximum observed concentration (Tmax)	Day 1 and Day 10
PK of TD-5202 when given as an MAD: C trough	concentration at trough (after multiple dosing usually after reaching steady state) (C trough)	Day 2, 4, 6, 8
PK of TD-5202 when given as an MAD: Css	concentration at steady state (Css)	Day 10
PK of TD-5202 when given as an MAD: CL/Fss	Oral clearance at steady state (CL/Fss)	Day 10
PK of TD-5202 when given as an MAD: Cmin	Concentration minimum (after single dosing) (Cmin)	Day 10
PK of TD-5202 when given as an MAD: Vz/Fss	Terminal phase volume of distribution at steady state (Vz/Fss)	Day 10
PK of TD-5202 when given as an MAD: Kel	Elimination Rate (Kel)	Day 10
PK of TD-5202 when given as an MAD: t 1/2	Halflife (t 1/2)	Day 10

Collaborators and Investigators

• Sponsor: Theravance Biopharma

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2019
• Primary Completion (Actual): November 27, 2019
• Study Completion (Actual): November 27, 2019

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Actual): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Phase 1; TD-5202; 0177; single ascending dose; SAD; multiple ascending dose; MAD; first-in-human
• Other Study ID Numbers: 0177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No