Bacterial Infections, Infections
Conditions
Keywords
Gram-positive
Brief summary
TD-1607, administered intravenously as multiple ascending doses, will be investigated in healthy subjects to assess its tolerability, safety, and pharmacokinetics.
Interventions
DRUGTD-1607
DRUGPlacebo
Sponsors
Theravance Biopharma
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | 17 days | Adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax | 17 Days | Pharmacokinetics |
| AUC0-t | 17 Days | Pharmacokinetics |
| AUC0-24 | 17 Days | Pharmacokinetics |
| AUCinf | 17 Days | Pharmacokinetics |
| CL | 17 Days | Pharmacokinetics |
| Cmax | 17 Days | Pharmacokinetics |
| t1/2 | 17 Days | Pharmacokinetics |
| Amount excreted in urine (Ae | 17 Days | Pharmacokinetics |
| Fraction eliminated in urine (fe) | 17 Days | Pharmacokinetics |
| CLr | 17 Days | Pharmacokinetics |
| Ctrough | 17 Days | Pharmacokinetics |
| Vdss | 17 Days | Pharmacokinetics |
Countries
United States
Outcome results
None listed