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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: TD-5202; Drug: Placebo

• Registration Number: NCT04044339
• Lead Sponsor: Theravance Biopharma

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2019-08-01
• Study First Posted: 2019-08-05
• Study Start: 2019-08-08
• Primary Completion: 2019-11-27
• Study Completion: 2019-11-27
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TD-5202 for SAD (Part A)	TD-5202	6 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive TD-5202
Placebo for SAD (Part A)	Placebo	2 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive placebo
TD-5202 for MAD (Part B)	TD-5202	6 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-5202
Placebo for MAD (Part B)	Placebo	2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo.

Primary Outcome Measures

Name	Time	Method
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	Day 1 through Day 4	Area under the plasma concentration-time curve (AUC)
Pharmacokinetics (PK) of TD-5202 when given as a SAD: Cmax	Day 1 through Day 4	Maximum observed concentration (Cmax)
Pharmacokinetics (PK) of TD-5202 when given as a SAD: Tmax	Day 1 through Day 4	Time to reach maximum observed concentration (Tmax)
PK of TD-5202 when given as an SAD: CL/F	Day 1 through Day 4	Oral Clearance (CL/F)
PK of TD-5202 when given as an SAD: Vz/F	Day 1 through Day 4	Terminal Phase Volume of Distribution(Vz/F)
PK of TD-5202 when given as an SAD: Kel	Day 1 through Day 4	Elimination Rate (Kel)
PK of TD-5202 when given as an SAD: t 1/2	Day 1 through Day 4	Halflife (t 1/2)
PK of TD-5202 when given as an MAD: AUC	Day 1 and Day 10	Area under the plasma concentration-time curve (AUC)
PK of TD-5202 when given as an MAD: Cmax	Day 1 and Day 10	Maximum observed concentration (Cmax)
PK of TD-5202 when given as an MAD: Tmax	Day 1 and Day 10	Time to reach maximum observed concentration (Tmax)
PK of TD-5202 when given as an MAD: C trough	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	Day 10	concentration at steady state (Css)
PK of TD-5202 when given as an MAD: CL/Fss	Day 10	Oral clearance at steady state (CL/Fss)
PK of TD-5202 when given as an MAD: Cmin	Day 10	Concentration minimum (after single dosing) (Cmin)
PK of TD-5202 when given as an MAD: t 1/2	Day 10	Halflife (t 1/2)
PK of TD-5202 when given as an MAD: Vz/Fss	Day 10	Terminal phase volume of distribution at steady state (Vz/Fss)
PK of TD-5202 when given as an MAD: Kel	Day 10	Elimination Rate (Kel)

Trial Locations

Locations (1)

Theravance Biopharma Investigational Site; 🇺🇸 Lincoln, Nebraska, United States