NCT05298046

Study of TAVO101 in Healthy Volunteers

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAVO101 in Adult Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Tavotek Biotherapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Experimental: TAVO101	TAVO101 single ascending dose IV infusion.
OTHER	Other: Placebo	Placebo single ascending dose IV infusion.

Timeline

• Start date: 2022-05-11
• Primary completion: 2024-06-01
• Completion: 2024-09-30
• First posted: 2022-03-28
• Last updated: 2024-11-19

Locations

1 site across 1 country: Australia