TD-1607 SAD Study in Healthy Subjects

Phase 1

Completed

• Conditions: Serious Infections Due to Known or Suspected Gram-positive Pathogens
• Interventions: Drug: TD-1607; Drug: Placebo

• Registration Number: NCT01791049
• Lead Sponsor: Theravance Biopharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-11
• Study First Submitted QC: 2013-02-11
• Study First Posted: 2013-02-13
• Study Start: 2013-04
• Primary Completion: 2013-08
• Study Completion: 2013-10
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Subject is a healthy nonsmoking male or a female of non-child bearing potential and 18 to 50 years old, inclusive, at Screening. Females are considered to be of non-childbearing potential if they have had a hysterectomy or tubal ligation or are postmenopausal (amenorrheic for at least 2 years) with a follicle-stimulating hormone (FSH) level >20 IU/L.
• Subject has a body mass index (BMI) of 19 to 30 kg/m2, inclusive, and weighs at least 50 kg

Exclusion Criteria

• Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
• Subject has a history of allergies or hypersensitivities to glycopeptide (e.g., vancomycin), 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active	TD-1607	Single escalating doses of TD-1607, administered intravenously
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	11 days	Adverse events, laboratory abnormalities, ECGs, and vital sign measurements.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics	96 hours	Cmax, Tmax, AUC0-t, AUC0-24, AUCinf, CL, Vdss, t1/2, amount excreted in urine (Ae), fraction eliminated in urine (fe), and CLr.

Trial Locations

Locations (1)

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