NCT06938204

Single Ascending Dose, Multiple Ascending Dose, Food Effect Study

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Ascending Dose, and Food-Effect Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of INV-101 Administered Orally to Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Innovo Therapeutics, Inc. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a 2-part study. Parts 1 and 2 will be a randomized, double-blind, placebo-controlled investigations of SAD (Part 1) and MAD (Part 2) of orally administered INV-101 in healthy adult subjects. Food effect will also be assessed in one cohort in Part 1.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	INV-101	SAD MAD
DRUG	INV-101 Placebo	SAD MAD

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-08-09
• Completion: 2024-09-13
• First posted: 2025-04-22
• Last updated: 2025-04-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study