Inhaled RB042 in Healthy Adult Volunteers, Healthy Adult Smokers and Patients With Chronic Obstructive Pulmonary Disease

Sponsor
Atisama Therapeutics
Study ID
NCT07285122
Phase
PHASE1
Status
Recruiting
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Conditions

  • COPD
  • COPD (Chronic Obstructive Pulmonary Disease)
  • Healthy
  • Healthy Smoker

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • RB042 — DRUG
    A single or multiple doses of RB042 will be administered via a nebuliser.
  • Placebo inhalation solution — DRUG
    A single or multiple doses of placebo will be administered via a nebuliser.

Study Details

This is a 4-part, randomised, double-blind, placebo-controlled, first in human study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of inhaled RB042.

Key Dates

First listed
Dec 16, 2025
Start date
Feb 16, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A1
    Participants will receive RB042 (Dose Level A1) or matching placebo on Day 1.
  • Experimental: Cohort A2
    Participants will receive RB042 (Dose Level A2) or matching placebo on Day 1.
  • Experimental: Cohort A3
    Participants will receive RB042 (Dose Level A3) or matching placebo on Day 1.
  • Experimental: Cohort A4
    Participants will receive RB042 (Dose Level A4) or matching placebo on Day 1.
  • Experimental: Cohort B1
    Participants will receive RB042 (Dose Level B1) or matching placebo on Days 1, 8, 15, and 22.
  • Experimental: Cohort B2
    Participants will receive RB042 (Dose Level B2) or matching placebo on Days 1, 8, 15, and 22.
  • Experimental: Cohort B3
    Participants will receive RB042 (Dose Level B3) or matching placebo on Days 1, 8, 15, and 22.
  • Experimental: Cohort B4
    Participants will receive RB042 (Dose Level B4) or matching placebo on Days 1, 8, 15, and 22.
  • Experimental: Cohort C1
    Participants will receive RB042 (Dose Level C1) or matching placebo on Days 1, 8, 15, and 22.
  • Experimental: Cohort D1
    Participants will receive RB042 (Dose Level D1) or matching placebo on Days 1, 8, 15, and 22.

Primary Outcome Measure

Number and frequency of treatment-emergent adverse events (TEAEs) [ Time Frame: From Day 1 until the end of the study (Day 85 for Part A; Day 106 for Parts B and D) ]

Central Contacts

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