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

NCT06933043 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-03-06

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

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.

Sponsors & Collaborators

  • Southern Star Research

    collaborator INDUSTRY

  • Navigator Medicines, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-20
Primary Completion
2025-11-20
Completion
2025-11-20
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06933043 on ClinicalTrials.gov