NCT06933043

A Study on the Safety, Tolerability, Bioavailability and Mechanism of Action of Intravenous NAV-240 in Adults.

A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous NAV-240 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Navigator Medicines, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to assess initial safety/tolerability of multiple doses of drug NAV-240. It will also learn about the profile and immunogenicity of drug NAV-240. The main question it aims to answer is: • What medical problems do participants have when taking multiple doses of drug NAV-240? Researchers will compare drug NAV-240 to a placebo (a look-alike substance that contains no drug) to see if any medical problems participants have differ between those taking drug NAV-240 and those taking placebo.

Detailed description

This randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) study will evaluate the safety, tolerability, pharmacokinetics (PK)/pharmacodynamics (PD), and immunogenicity of NAV-240.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	NAV-240	Three doses of intravenous (IV) low dose, medium dose or high dose NAV-240 will be administered to participants.
DRUG	Placebo	Three doses of matching placebo will be administered to participants.

Timeline

• Start date: 2025-05-20
• Primary completion: 2025-11-20
• Completion: 2025-11-20
• First posted: 2025-04-17
• Last updated: 2026-03-06

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study