RIG 101 Trial in Healthy Adults and Adults With Asthma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRIGImmune Inc.
About this trial
Nested Phase 1-2 Trial of RIG-101 in Healthy and Asthmatic Participants Assessing Safety, Tolerability and Viral Challenge Efficacy
Eligibility criteria
Qualifiers
Participants must have a written informed consent obtained prior to any trial related procedure
Male and female participants aged between 18 to 65 years inclusive, at the time of informed consent.
Participants must be in good health as determined by medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory assessments at the time of screening, as judged by the Investigator.
Participants must have a clinical diagnosis of asthma.
Disqualifiers
History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the participant's safety during the clinical trial, expose the participant to undue risk or interfere with the participants ability to successfully conduct the trial, as judged by the Investigator.
Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the trial at time of screening.
Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months of the first administration of IMP and/or history of being hospitalized due to epistaxis on any previous occasion.
Any nasal or sinus surgery within 3 months of the first administration of IMP
Trial design
Treatments tested in this trial
- RIG-101
- Placebo
Treatment groups
82 Participants
are divided into 2 treatment groupsSponsors and collaborators
RIGImmune Inc.
Lead sponsor
Virtus Respiratory Research
Collaborator
Medicines Evaluation Unit Ltd
Collaborator
Source ClinicalTrials.gov