Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID06488118

Lung Immune Challenge Study Controlled Exposure to Inhaled Resiquimod (R848) to Study Mechanisms of Inflammation

Led by Akhilesh Jha · Updated on 2024-07-10

36

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

A

Akhilesh Jha

Lead Sponsor

U

University of Cambridge

Collaborating Sponsor

AI-Summary

What this Trial Is About

Respiratory viral infections can cause serious illness, especially in people with lung conditions like asthma. This research aims to better understand how the immune system responds to these infections by studying inflammation in the lungs. Researchers are evaluating a new approach using a substance called Resiquimod (R848) to mimic viral infection without causing actual illness, which may help develop better treatments for lung inflammation. The study involves inhaling a fine mist of Resiquimod at different doses through a mouthpiece to trigger a controlled immune response in the lungs. Participants are randomly assigned to receive various doses of Resiquimod or a saline (saltwater) placebo. After determining the highest tolerated dose in healthy adults, this dose will also be tested in people with mild to moderate asthma. The dosing starts very low and is gradually increased to find the best balance between immune activation and tolerability. Participants will be closely monitored for symptoms, lung function, and vital signs for 24 hours after inhalation in a research facility. Blood and sputum samples will be collected to measure inflammation markers, especially CXCL10, which indicates immune activation. The study measures changes in lung function, temperature, pulse, blood pressure, and immune cell counts at multiple time points up to 48 hours after dosing. Total participation will last about three weeks from screening to follow-up.

CONDITIONS

Brief Title

Lung Immune Challenge Study: Controlled Exposure to Inhaled Resiquimod (R848)

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged between 18 and 60 years.
  • Willing and able to give informed consent for participation in the study.
  • Female participants of child-bearing potential and male participants whose partner is of child-bearing potential must use effective contraception during the study.
  • Clinically acceptable laboratory measurements and ECG at enrolment.
  • Ability to expectorate sputum.
  • No clinical history of asthma for healthy volunteers.
  • Normal baseline spirometry for healthy volunteers (FEV1/FVC ratio z-score above the lower limit of normal).
  • For asthma volunteers: physician-diagnosed mild to moderate asthma that is not poorly controlled (ACQ-5 score ≤1.5).
  • Asthma volunteers may be on inhaled corticosteroids, long-acting beta agonists, and long-acting muscarinic antagonists.
  • Pre-bronchodilator FEV1 ≥70% predicted for asthma volunteers.
  • Evidence of bronchial hyperreactivity for asthma volunteers, demonstrated by bronchodilator reversibility, positive methacholine challenge, or positive challenge test per policy.
Not Eligible

You will not qualify if you...

  • Upper respiratory tract infection in the past 14 days.
  • Lower respiratory tract infection in the past 28 days.
  • Female participants who are pregnant, breastfeeding, or planning pregnancy.
  • Respiratory diseases other than asthma where specified.
  • Significant medical conditions outside the lungs.
  • Extreme obesity (BMI over 40).
  • Any other significant disease or disorder that may pose risk or affect study participation or results.
  • Participation in another investigational study within the past 12 weeks.
  • Newly prescribed medications including corticosteroids in the 4 weeks before the first study dose, except mild analgesics, vitamins, and supplements.
  • Smoking tobacco or vaping in the past 6 months.
  • Smoking history of more than 5 pack years.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to several days including monitoring for 48 hours after inhalation

Participants inhale ascending doses of Resiquimod (R848) or saline to study the immune response in the lungs. Their symptoms, airway function, and physiological observations are closely monitored during and after the inhalation challenge.

1 inhalation visit with monitoring during the first 24 hours and follow-up visits at 1, 4, 8, 24, and 48 hours post-dose

Trial Site Locations

Total: 1 location

1

NIHR Cambridge Clinical Research Facility

Cambridge, Cambridgeshire, United Kingdom, CB2 0SL

Actively Recruiting

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Research Team

A

Akhilesh Jha, MBBS; MRCP; PhD

J

Jade Joseph, BSc; MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

8

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Published Research Related To This Trial

Induction of innate cytokine responses by respiratory mucosal challenge with R848 in zebrafish, mice, and humans.

Fränze Progatzky, Akhilesh Jha, Madina Wane...

https://pubmed.ncbi.nlm.nih.gov/31002833