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| Name | Class |
|---|---|
| Tes Pharma AU Pty Ltd | UNKNOWN |
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The goal of this intervention study is to evaluate the safety and tolerability of TESP-0401, and to understand how the body processes TESP-0401, in healthy participants after single and multiple doses. The study aims to answer the following questions: 1. What are the safety, tolerability, and pharmacokinetic characteristics of a single dose of TESP-0401 in healthy participants? 2. What are the safety, tolerability, and pharmacokinetic characteristics of multiple doses of TESP-0401 in healthy participants? This study will be a randomized, placebo controlled study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A SAD - Cohort 1 | Experimental | IV, once, over 60 minutes, in a fasted state |
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| Part A SAD - Placebo Cohort 1 | Placebo Comparator | IV infusion of placebo, once, over 60 minutes, in a fasted state |
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| Part A SAD - Cohort 2 | Experimental | IV, once, over 60 minutes, in a fasted state |
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| Part A SAD - Placebo Cohort 2 | Placebo Comparator | IV infusion of placebo, once, over 60 minutes, in a fasted state |
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| Part A SAD - Cohort 3 | Experimental | IV, once, over 60 minutes, in a fasted state |
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| Part A SAD - Placebo Cohort 3 | Placebo Comparator | IV infusion of placebo, once, over 60 minutes, in a fasted state |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TESP-0401 | Drug | IV infusion, single administration, over 60 minutes, in a fasted state |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with SAEs, TEAEs, with abnormal clinical laboratory tests results, abnormal vital signs, abnormal ECG readings and abnormal physical examination findings | up to 8 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration of the drug (Cmax) following single and multiple doses of TESP-0401 in healthy participants | Will be conducted using a non-compartmental approach. | up to 9 days |
| Time to peak concentration (Tmax) following single and multiple doses of TESP-0401 in healthy participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Martin | Contact | +6140961159 | jennifer@novatrials.com.au |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novatrials | Charlestown | Suite 301, 99 Pacific Highway,NSW | 2290 | Australia |
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| Part A SAD - Cohort 4 | Experimental | IV, once, over 60 minutes, in a fasted state |
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| Part A SAD - Placebo Cohort 4 | Placebo Comparator | IV infusion of placebo, once, over 60 minutes, in afasted state |
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| Part A SAD - Cohort 5 | Experimental | IV, once, over 60 minutes, in a fasted state |
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| Part A SAD - Placebo Cohort 5 | Placebo Comparator | IV infusion of placebo, once, over 60 minutes, in a fasted state |
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| Part A SAD - Cohort 6 | Experimental | IV, once, over 60 minutes in a fasted state |
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| Part A SAD - Placebo Cohort 6 | Placebo Comparator | IV infusion of placebo, once, over 60 minutes, in a fasted state |
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| Part B MAD - Cohort 1 | Experimental | IV infusion,QD for 7 days, over 60 minutes, ina fasted state |
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| Part B MAD - Placebo Cohort 1 | Placebo Comparator | IV infusion of placebo, QD for 7 days, over 60 minutes, in a fasted state |
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| Part B MAD - Cohort 2 | Experimental | IV infusion, QD for 7 days, over 60 minutes,in a fasted state |
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| Part B MAD - Placebo Cohort 2 | Placebo Comparator | IV infusion of placebo, QD for 7 days, over 60 minutes, in a fasted state |
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| Part B MAD - Cohort 3 | Experimental | IV infusion, QD for 7 days, over 60 minutes,in a fasted state |
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| Part B MAD - Placebo Cohort 3 | Placebo Comparator | IV infusion of placebo, QD for 7 days, over 60 minutes, in a fasted state |
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| Part B MAD - Cohort 4 | Experimental | IV infusion, QD for 7 days, over 60 minutes,in a fasted state |
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| Part B MAD - Placebo Cohort 4 | Placebo Comparator | IV infusion of placebo, QD for 7 days, over 60 minutes, in a fasted state |
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| Placebo | Drug | IV infusion of placebo, once, over 60 minutes, in a fasted state |
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| TESP-0401 | Drug | IV infusion, QD for 7 days, over 60 minutes, in a fasted state |
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| Placebo | Drug | IV infusion of placebo, QD for 7 days, over 60 minutes, in a fasted state |
|
Will be conducted using a non-compartmental approach. |
| up to 9 days |
| Clearance (CL) following single and multiple doses of TESP-0401 in healthy participants | Will be conducted using a non-compartmental approach. | up to 9 days |
| Elimination half-life (t1/2) following single and multiple doses of TESP-0401 in healthy participants | Will be conducted using a non-compartmental approach. | up to 9 days |
| Volume of distribution (Vd) following single and multiple doses of TESP-0401 in healthy participants. | Will be conducted using a non-compartmental approach. | up to 9 days |
| Area under the curve (AUC) - AUC0-24h, AUC0-last, AUC0-inf following single and multiple doses of TESP-0401 in healthy participants. | Will be conducted using a non-compartmental approach. | up to 9 days |
| Accumulation ratio (AR) following single and multiple doses of TESP-0401 in healthy participants. | Will be conducted using a non-compartmental approach. | up to 9 days |