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RIG 101 Trial in Healthy Adults and Adults With Asthma

ConditionsHealthy Adult ParticipantsAsthma ExacerbationSafety and Efficacy
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • RIG-101

    Drug

    Single, and repeat escalating intranasal administrations of RIG-101

  • Placebo

    Other intervention

    Single and repeat Intranasal administrations

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: RIG-101Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Events (AEs) and Serious Adverse Events (SAEs)

All adverse events (AEs) and serious adverse events (SAEs) will be collected using standard regulatory AE/SAE monitoring procedures. Events will be assessed for severity and relationship to intranasal RIG-101 according to protocol-defined criteria. Data will be recorded from the signing of informed consent through the follow-up visit.

Time frame
Day 1-35
2

Systolic/Diastolic blood pressure

Systolic/Diastolic blood pressure will be measured after participants rest in a supine position for ≥5 minutes. Unit of Measure: Change from baseline mmHg

Time frame
Day 0 - 35
3

Physical examinations

Physical examinations-general and system-specific (cardiovascular, respiratory, ENT, lymphatic, neurological, abdominal, musculoskeletal, dermatologic)-will be performed per protocol. Findings will be categorized as normal or abnormal, with clinical significance determined by the investigator. Unit of Measure: Incidence of clinically significant physical exam abnormalities

Time frame
Day 0 -35
4

Nasal examinations

Nasal examinations are performed to identify structural anomalies, inflammation, or other abnormalities in the anterior nares. Unit of Measure: Incidence of nasal exam abnormalities

Time frame
Day 0 - 35

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RIGImmune Inc.

Lead sponsor

Virtus Respiratory Research

Collaborator

Medicines Evaluation Unit Ltd

Collaborator

Source ClinicalTrials.gov
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