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This Study Collects Information on the Safety of Inhaled Pegylated Adrenomedullin (PEG-ADM), How the Drug is Tolerated and How it Affects Patients Suffering From a Type of Lung Failure That Cause Fluid to Build up in the Lungs Making Breathing Difficult (ARDS) (SEAL Trial)

Phase 2
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 28 and day 60

Summary

This trial tests an inhaled medicine called pegylated adrenomedullin to help patients with severe lung problems (ARDS) breathe easier by reducing lung inflammation and fluid buildup.

Eligible Conditions
  • Acute Respiratory Distress Syndrome (ARDS)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 28 and day 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 28 and day 60 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
VFS in Part B participants
Secondary study objectives
CUI in Part A participants
Integrated analysis on VFS invoving all participants from Part A and Part B
VFS in Part A and Part B participants
+1 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B - Active Drug DoseExperimental Treatment2 Interventions
Participants will receive Active Drug 1 or 2 for a maximum of 14 days in study phase Part B
Group II: Part A - Active Drug Dose 2Experimental Treatment1 Intervention
Participants will receive Active Drug Dose 2 for a maximum of 14 days in study phase Part A
Group III: Part A - Active Drug Dose 1Experimental Treatment1 Intervention
Participants will receive Active Drug Dose 1 for a maximum of 14 days in study phase Part A
Group IV: Part A - PlaceboPlacebo Group1 Intervention
Participants will receive Placebo for a maximum of 14 days in study phase Part A
Group V: Part B - PlaceboPlacebo Group1 Intervention
Participants will receive Placebo for a maximum of 14 days in study phase Part B

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,275 Previous Clinical Trials
25,539,309 Total Patients Enrolled
~17 spots leftby Dec 2025
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