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Investigating potential treatments for human lung injury in healthy volunteers

Phase 1
Conditions
Acute Respiratory Distress Syndrome (ARDS)
Respiratory
Registration Number
ISRCTN16086655
Lead Sponsor
Belfast Health and Social Care Trust
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Ongoing
Sex
All
Target Recruitment
30
Inclusion Criteria

Healthy non-smoking adults aged 18-45 years old

Exclusion Criteria

1. Age <18 years
2. Age >45 years
3. BMI >30 kg/m2
4. On concomitant medications including over-the-counter medications excluding hormonal contraception and paracetamol
5. Previous adverse reactions to LPS, lignocaine or sedative agents
6. Pregnant or breast-feeding
7. Participation in a clinical trial of an investigational medicinal product within 30 days
8. Consent declined
9. History of asthma or other respiratory conditions
10. Smoking or e-cigarette use
11. Marijuana use or other inhaled products (with or without nicotine) in the last 3 months
12. Alcohol abuse, as defined by the Alcohol Use Disorders Identification Test (AUDIT)
13. Subjects with history of prior conventional cigarette (> 100 cigarettes lifetime and smoking within 6 months) or electronic cigarette use.
14. Live vaccine with in preceeding 4 weeks
15. Abnormal blood count, renal function or liver function tests identified at screening
16. History of shingles
17. History of Hepatitis B/C
18. Allergy to Baricitinib

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Broncho-alveolar lavage neutrophil count during bronchoscopy at day 4
Secondary Outcome Measures
NameTimeMethod
Broncho-alveolar lavage fluid/Plasma/Urine: cytokines including but not limited to Il-6, IL-10, IL-18, CXCL8, IL-1b, markers of epithelial and endothelial injury including but not limited to RAGE, SP-D, Ang2, single-cell RNA sequencing, plasma differential white cell count, BAL differential white cell count, plasma C-reactive protein
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