TD-1607 MAD Study in Healthy Subjects

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

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1607, a Glycopeptide-Cephalosporin Heterodimer Antibiotic, in Healthy Subjects

Conditions
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Infections, Bacterial Infections

Intervention / Treatment
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* Drug: TD-1607
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TD-1607 or placebo (Dose1)<br>TD-1607 or placebo administered intravenously | Drug: TD-1607<br> <br> Drug: Placebo<br> <br> |
| Experimental: TD-1607 or placebo (Dose 2)<br>TD-1607 or placebo administered intravenously | Drug: TD-1607<br> <br> Drug: Placebo<br> <br> |
| Experimental: TD-1607 or placebo (Dose 3)<br>TD-1607 or placebo administered intravenously | Drug: TD-1607<br> <br> Drug: Placebo<br> <br> |
| Experimental: TD-1607 or placebo (Dose 4)<br>TD-1607 or placebo administered intravenously | Drug: TD-1607<br> <br> Drug: Placebo<br> <br> |
| Experimental: TD-1607 or placebo (Dose 5) [Optional]<br>TD-1607 or placebo administered intravenously | Drug: TD-1607<br> <br> Drug: Placebo<br> <br> |
| Experimental: TD-1607 or placebo (Dose 6) [Optional]<br>TD-1607 or placebo administered intravenously | Drug: TD-1607<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events | Adverse events | 17 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gram-positive