TD-1607 MAD Study in Healthy Subjects

Phase 1

Completed

• Conditions: Bacterial Infections; Infections
• Interventions: Drug: TD-1607; Drug: Placebo

• Registration Number: NCT01949103
• Lead Sponsor: Theravance Biopharma

Brief Summary

TD-1607, administered intravenously as multiple ascending doses, will be investigated in healthy subjects to assess its tolerability, safety, and pharmacokinetics.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-17
• Study First Submitted QC: 2013-09-23
• Study First Posted: 2013-09-24
• Study Start: 2013-10
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Subject is a healthy nonsmoking male or a female (of non-childbearing potential) and 18 to 55 years old, inclusive, at Screening.
• Subject has a body mass index (BMI) of 19 to 30 kg/m2, inclusive, and weighs at least 50 kg.

Subject has no clinically significant abnormalities in the results of laboratory evaluations at Screening and Day -1.

Exclusion Criteria

• Subject has evidence or history of clinically significant, relevant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (except for untreated, asymptomatic seasonal allergies at time of dosing).
• Subject has a history of allergies or hypersensitivities to glycopeptide (e.g., vancomycin) or beta-lactam (e.g., penicillin or cephalosporin) antibiotics.
• Subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives, whichever is longer) prior to Screening or is currently participating in another trial of an investigational drug (or medical device).
• Subject has previously participated in a trial for TD-1607.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TD-1607 or placebo (Dose1)	TD-1607	TD-1607 or placebo administered intravenously
TD-1607 or placebo (Dose 4)	Placebo	TD-1607 or placebo administered intravenously
TD-1607 or placebo (Dose 5) [Optional]	TD-1607	TD-1607 or placebo administered intravenously
TD-1607 or placebo (Dose1)	Placebo	TD-1607 or placebo administered intravenously
TD-1607 or placebo (Dose 4)	TD-1607	TD-1607 or placebo administered intravenously
TD-1607 or placebo (Dose 2)	TD-1607	TD-1607 or placebo administered intravenously
TD-1607 or placebo (Dose 2)	Placebo	TD-1607 or placebo administered intravenously
TD-1607 or placebo (Dose 3)	Placebo	TD-1607 or placebo administered intravenously
TD-1607 or placebo (Dose 6) [Optional]	TD-1607	TD-1607 or placebo administered intravenously
TD-1607 or placebo (Dose 6) [Optional]	Placebo	TD-1607 or placebo administered intravenously
TD-1607 or placebo (Dose 5) [Optional]	Placebo	TD-1607 or placebo administered intravenously
TD-1607 or placebo (Dose 3)	TD-1607	TD-1607 or placebo administered intravenously

Primary Outcome Measures

Name	Time	Method
Number of adverse events	17 days	Adverse events

Secondary Outcome Measures

Name	Time	Method
CL	17 Days	Pharmacokinetics
t1/2	17 Days	Pharmacokinetics
AUC0-t	17 Days	Pharmacokinetics
AUC0-24	17 Days	Pharmacokinetics
Cmax	17 Days	Pharmacokinetics
Tmax	17 Days	Pharmacokinetics
Vdss	17 Days	Pharmacokinetics
Fraction eliminated in urine (fe)	17 Days	Pharmacokinetics
Ctrough	17 Days	Pharmacokinetics
CLr	17 Days	Pharmacokinetics
Amount excreted in urine (Ae	17 Days	Pharmacokinetics
AUCinf	17 Days	Pharmacokinetics

Trial Locations

Locations (1)

PPD, Phase 1 Clinic; 🇺🇸 Austin, Texas, United States