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

NCT04044339 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 0177
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

TD-5202; 0177; single ascending dose; SAD; multiple ascending dose; MAD; first-in-human; Phase 1

Outcome Measures

Primary Outcomes (19)

• 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

Study Arms (4)

TD-5202 for SAD (Part A)

EXPERIMENTAL

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

Drug: TD-5202

Placebo for SAD (Part A)

PLACEBO COMPARATOR

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

Drug: Placebo

TD-5202 for MAD (Part B)

EXPERIMENTAL

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

Drug: TD-5202

Placebo for MAD (Part B)

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

TD-5202 DRUG

Study Drug to be administered orally

TD-5202 for MAD (Part B); TD-5202 for SAD (Part A)

Placebo DRUG

Placebo to be administered orally

Placebo for MAD (Part B); Placebo for SAD (Part A)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

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

Sponsors & Collaborators

• Theravance Biopharma: lead

Study Sites (1)

Theravance Biopharma Investigational Site

Lincoln, Nebraska, 68502, United States

Location

Study Officials

• Medical Monitor

  Theravance Biopharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 5, 2019
• Study Start: August 8, 2019
• Primary Completion: November 27, 2019
• Study Completion: November 27, 2019
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)