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This is a Phase 1, single ascending dose study designed to investigate TAVO101, administered as an IV infusion in healthy subjects. This study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAVO101.
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD), single site study. Six subjects will be enrolled into each of the 7 dosing cohorts. Subjects will be randomized at a ratio of 2:1 to receive TAVO101 or placebo. Two sentinel subjects will be utilized (1 active:1 placebo) in each cohort in a manner designed to maintain the blind. Subjects will be evaluated for safety throughout the study up through day 196.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAVO101: Low dose | Experimental | TAVO101: TAVO101 single ascending dose IV infusion. |
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| TAVO101: Medium dose | Experimental | TAVO101: TAVO101 single ascending dose IV infusion. |
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| TAVO101: High dose | Experimental | TAVO101: TAVO101 single ascending dose IV infusion. |
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| Placebo | Placebo Comparator | Placebo single ascending dose IV infusion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: TAVO101 | Drug | TAVO101 single ascending dose IV infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| The severity of adverse effects according to the National Cancer Institute's Common Terminology Criteria for AEs, Version 5.0 [Time Frame: Day 1 through Day 196] | To investigate the safety and tolerability of TAVO101 in healthy volunteers. | 196 days |
| Changes in vital signs including oral temperature or tympanic temperature (C°) [Time Frame: Day 1 through Day 196] | To investigate the safety and tolerability of TAVO101 in healthy volunteers. | 196 days |
| Changes in vital signs including respiratory rate (breaths per minute) [Time Frame: Day 1 through Day 196] | To investigate the safety and tolerability of TAVO101 in healthy volunteers. | 196 days |
| Changes in vital signs including systolic and diastolic blood pressure (mmHg) [Time Frame: Day 1 through Day 196] | To investigate the safety and tolerability of TAVO101 in healthy volunteers. | 196 days |
| Changes in vital signs including pulse rate (beats per minute) [Time Frame: Day 1 through Day 196] | To investigate the safety and tolerability of TAVO101 in healthy volunteers. | 196 days |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of TAVO101 [ Time Frame: Day 1 through Day 196 ] | Incidence of anti-drug antibodies (ADA) following dosing of TAVO101 | 196 days |
| Cmax (Maximum observed serum concentration ) [ Time Frame: Day 1 through Day 196 ] |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX Clinical Research Pty Ltd | Adelaide | South Australia | 5000 | Australia |
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| Other: Placebo | Other | Placebo single ascending dose IV infusion. |
|
To investigate the pharmacokinetics of TAVO101 in healthy volunteers.
| 196 days |
| tmax (time that Cmax was observed) [ Time Frame: Day 1 through Day 196 ] | To investigate the pharmacokinetics of TAVO101 in healthy volunteers. | 196 days |
| AUC-last (Area under the serum concentration-time curve from time 0 to the time of the last quantifiable concentration; calculated using the linear/log trapezoid rule) [ Time Frame: Day 1 through Day 196 ] | To investigate the pharmacokinetics of TAVO101 in healthy volunteers. | 196 days |
| AUC-inf (Area under the serum concentration-time curve from time 0 extrapolated to infinity) [ Time Frame: Day 1 through Day 196 ] | To investigate the pharmacokinetics of TAVO101 in healthy volunteers. | 196 days |
| AUC0-t (Area under the serum concentration-time curve from time 0 to time t) [ Time Frame: Day 1 through Day 196 ] | To investigate the pharmacokinetics of TAVO101 in healthy volunteers. | 196 days |
| t½ (Terminal elimination half-life) [ Time Frame: Day 1 through Day 196 ] | To investigate the pharmacokinetics of TAVO101 in healthy volunteers. | 196 days |
| λz (Terminal elimination rate constant) [ Time Frame: Day 1 through Day 196 ] | To investigate the pharmacokinetics of TAVO101 in healthy volunteers. | 196 days |
| CL (Systemic clearance) [ Time Frame: Day 1 through Day 196 ] | To investigate the pharmacokinetics of TAVO101 in healthy volunteers. | 196 days |
| Vd (Volume of distribution) [ Time Frame: Day 1 through Day 196 ] | To investigate the pharmacokinetics of TAVO101 in healthy volunteers. | 196 days |