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Virus Therapy

TAVO103A for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Tavotek Biotherapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 196 days
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and how it affects the body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~196 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 196 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in vital signs including oral temperature or tympanic temperature (C°) [Time Frame: Day 1 through Day 196]
Changes in vital signs including pulse rate (beats per minute) [Time Frame: Day 1 through Day 196]
Changes in vital signs including respiratory rate (breaths per minute) [Time Frame: Day 1 through Day 196]
+2 more
Secondary outcome measures
AUC-inf (Area under the serum concentration-time curve from time 0 extrapolated to infinity) [Time Frame: Day 1 through Day 196]
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]
AUC0-t (Area under the serum concentration-time curve from time 0 to time t) [Time Frame: Day 1 through Day 196]
+7 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: TAVO10A Medium DoseExperimental Treatment1 Intervention
TAVO103A: TAVO103A single ascending dose IV infusion.
Group II: TAVO103A Low DoseExperimental Treatment1 Intervention
TAVO103A: TAVO103A single ascending dose IV infusion.
Group III: TAVO103A High DoseExperimental Treatment1 Intervention
TAVO103A: TAVO103A single ascending dose IV infusion.
Group IV: PlaceboPlacebo Group1 Intervention
Placebo single ascending dose IV infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAVO103A
2022
Completed Phase 1
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Tavotek BiotherapeuticsLead Sponsor
3 Previous Clinical Trials
112 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation actively seeking participants at present?

"This medical study, initially posted to clinicaltrials.gov on April 5th 2022, is not recruiting patients at this moment in time. Last updated on September 20th 2022, there are 841 other trials searching for candidates around the world."

Answered by AI

What objectives is this experiment seeking to fulfill?

"This 196 day study will measure changes in vital signs such as pulse rate over time, and also track AUC0-t (Area under the serum concentration-time curve from time 0 to time t) , t½ (Terminal elimination half-life), and Immunogenicity of TAVO103A. The purpose here is to evaluate pharmacokinetics and ADA incidence in healthy volunteers after dosing with TAVO103A."

Answered by AI

Is the age cut off for eligibility in this research set at 35 and below?

"The enrollment requirements for this clinical trial necessitate that all participants are between the ages of 18 and 65."

Answered by AI

To whom is this experimental research open?

"The requirements for this clinical trial necessitate that potential participants display healthy subjects (HS) and are between the ages of 18-65. Further, approximately 30 people must be enrolled in order to meet the study's criteria."

Answered by AI

Has the Food and Drug Administration approved TAVO103A for clinical usage?

"Due to the limited clinical information available, TAVO103A has been rated 1 on our safety scale. This is a Phase 1 trial, meaning there are no large-scale studies demonstrating its efficacy or safety yet."

Answered by AI

Who else is applying?

What state do they live in?
Utah
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of TAVO103A in Healthy Volunteers
2022. "Study of TAVO103A in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05313152.
~10 spots leftby Apr 2025
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