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This is a Phase 1, single ascending dose study designed to investigate TAVO103A, administered as an IV infusion up to 60 minutes in length to healthy adult subjects. This study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAVO103A.
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD), single site study. There will be up to 5 SAD cohorts with 6 subjects enrolled into each. Subjects will be randomized at a ratio of 2:1 to receive TAVO103A or placebo. Subjects will be evaluated for safety throughout the study up through day 196.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAVO103A Low Dose | Experimental | TAVO103A: TAVO103A single ascending dose IV infusion. |
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| TAVO10A Medium Dose | Experimental | TAVO103A: TAVO103A single ascending dose IV infusion. |
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| TAVO103A High Dose | Experimental | TAVO103A: TAVO103A 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 |
|---|---|---|---|---|
| TAVO103A | Drug | TAVO103A single ascending dose IV infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| The severity of adverse effects according to the CTCAE Guidance for Industry, Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials [Time Frame: Day 1 through Day 196] | To investigate the safety and tolerability of TAVO103A in healthy volunteers. The Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials will be graded according to the National Cancer Institute's Common Terminology Criteria for AEs, Version 5.0. Which will have a minimum value of Grade 1, or mild, and a maximum value of Grade 4, or Potentially Life Threatening. | 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 TAVO103A 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 TAVO103A 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 TAVO103A 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 TAVO103A in healthy volunteers. | 196 days |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of TAVO103A [Time Frame: Day 1 through Day 196] | Incidence of anti-drug antibodies (ADA) following dosing of TAVO103A | 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 |
|---|---|---|---|---|---|---|
| ICON | Salt Lake City | Utah | 84124 | United States |
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| Placebo | Other | Placebo single ascending dose IV infusion. |
|
To investigate the pharmacokinetics of TAVO103A in healthy volunteers.
| 196 days |
| tmax (time that Cmax was observed) [Time Frame: Day 1 through Day 196] | To investigate the pharmacokinetics of TAVO103A 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 TAVO103A 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 TAVO103A 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 TAVO103A in healthy volunteers. | 196 days |
| t½ (Terminal elimination half-life) [Time Frame: Day 1 through Day 196] | To investigate the pharmacokinetics of TAVO103A in healthy volunteers. | 196 days |
| λz (Terminal elimination rate constant) [Time Frame: Day 1 through Day 196] | To investigate the pharmacokinetics of TAVO103A in healthy volunteers. | 196 days |
| CL (Systemic clearance) [Time Frame: Day 1 through Day 196] | To investigate the pharmacokinetics of TAVO103A in healthy volunteers. | 196 days |
| Vd (Volume of distribution) [Time Frame: Day 1 through Day 196] | To investigate the pharmacokinetics of TAVO103A in healthy volunteers. | 196 days |