NCT07285122

Inhaled RB042 in Healthy Adult Volunteers and Healthy Adult Smokers

A Phase I, Randomised, Double Blind, Placebo-controlled, Dose-escalating Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of RB042 Administered Via Inhalation to Healthy Adult Volunteers and Healthy Adult Smokers

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: RAGE Bio · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a 3-part, randomised, double-blind, placebo-controlled, first in human study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of inhaled RB042.

Detailed description

The purpose of this study is to measure the safety, tolerability, PK, and PD of inhaled RB042 compared with inhaled placebo in healthy adult volunteers and healthy adult smokers. Study details include: * Overall study duration of up to 14 months. * Participants in Part A (healthy adult volunteers) will be required to visit the study site for assessments on 11 occasions, including a 4-day in-house stay, over 4 months. * Participants in Parts B (healthy adult volunteers) and C (healthy adult smokers) will be required to visit the study site for assessments on 13 occasions, including a 17-day (Day -1 to 16) and 3-day (Day 21 to 24) in-house stay, over 5 months. * Participants will be administered a single dose (Part A) or multiple doses (Parts B and C) of study intervention.

Conditions

• Healthy
• Healthy Smoker

Interventions

Type	Name	Description
DRUG	RB042	A single or multiple doses of RB042 will be administered via a nebuliser.
DRUG	Placebo inhalation solution	A single or multiple doses of placebo will be administered via a nebuliser.

Timeline

• Start date: 2026-02-16
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2025-12-16
• Last updated: 2026-02-23

Locations

1 site across 1 country: Australia