2-part trial of RIG-101 safety, tolerability, and efficacy in healthy & asthma with viral challenge
Research type
Research Study
Full title
A two-part, randomized, double-blind, placebo-controlled trial to assess the safety and tolerability of single and repeat ascending intranasal doses of RIG-101 in healthy participants, followed by repeat daily administration in adult participants with asthma [Part A] followed by a randomized, double-blind, placebo-controlled part to assess the efficacy and safety of RIG-101 in adult participants with asthma before and after viral challenge with Human Rhinovirus RV-A16 [Part B].
IRAS ID
1012376
Contact name
Brett Haumman
Contact email
Sponsor organisation
RIGImmune
Research summary
The Sponsor, RIGImmune Inc, is developing a new experimental study medication called RIG-101.
RIG-101 is initially being developed for regular use in people with asthma to help control their disease when they are exposed to common respiratory viruses, such as the flu, rhinovirus and coronavirus. RIG-101 works by turning on virus-fighting genes the body needs to fight off infections.
Asthma is a lung disease associated with inflammation of the airways, where airflow is restricted to the lungs and can result in wheezing and shortness of breath. The main healthcare risk to people with asthma is during an asthma attack which occurs after exposure to a trigger including pollution, allergens and respiratory viruses. Hence RIG-101 may reduce the severity of asthma attacks by defending the body against viruses.
Part A Cohort 1-3 will assess the safety and tolerability of increasing single and repeat doses of RIG-101 in healthy participants when given intranasally (inhaled through the nose). Nasal samples will be taken to assess if study medication is reaching targeted cells, target engagement (TE). Blood and nasal samples will be taken to measure the levels of study medication in the body and the time it takes for the body to break it down (known as ‘Pharmacokinetic’ (PK) analysis), and/or measure how the drug affects the body (known as ‘Pharmacodynamic‘ (PD) analysis).
Part A Cohort 4, 5 (optional cohort) will assess the safety and tolerability of repeat doses of inhaled RIG-101 in participants with asthma. Blood and nasal samples will be taken to assess for TE, PK and/or PD analysis.
Part B will assess the safety and effects of RIG-101 when given to participants with asthma who have been purposely infected with the human cold virus Rhinovirus A16 (RV-A16).The protective effect of RIG-101 will be assessed by checking symptoms within the 7 days following the rhinovirus challenge. Blood and nasal samples will be taken to assess for TE, PK and PD analysis.REC name
North East - York Research Ethics Committee
REC reference
25/NE/0196
Date of REC Opinion
19 Jan 2026
REC opinion
Further Information Favourable Opinion