NCT05313152

Study of TAVO103A in Healthy Volunteers

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAVO103A in Adult Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (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 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.

Detailed description

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	TAVO103A	TAVO103A single ascending dose IV infusion.
OTHER	Placebo	Placebo single ascending dose IV infusion.

Timeline

• Start date: 2022-04-05
• Primary completion: 2023-04-26
• Completion: 2023-06-08
• First posted: 2022-04-06
• Last updated: 2023-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study