A first in man study to treat acute cough on coronavirus [COVID-19]
Research type
Research Study
Full title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First-in-Human Study to Assess the Safety, Tolerability, and Pharmacokinetic Profiles of Single- and Multiple Ascending Inhaled Doses of NOC-100 in Healthy Adult Subjects
IRAS ID
284264
Contact name
David Bell
Contact email
Sponsor organisation
Nocion Therapeutics, Inc.
Eudract number
2020-002057-26
Duration of Study in the UK
0 years, 5 months, 24 days
Research summary
Cough is one of the main symptoms of coronavirus (COVID-19). Many patients with COVID-19 develop a cough early on in the course of the disease. Cough also plays a substantial role in the transmission, or spread, of SARS-CoV-2. Currently, there are no therapies targeting cough in patients with COVID-19. \n\nNOC-100 is being studied as a treatment for cough, in order to provide relief from the symptom of cough in patients with COVID-19. It is thought that by reducing cough n patients with COVID-19, NOC-100 may also be valuable in reducing transmission of SARS-CoV-2 (and thereby, COVID-19) amongst the general population, including healthcare workers at the frontline of the current pandemic.\n\n\nThe purposes of this clinical trial are to:\n•\tLearn about the safety of NOC-100\n•\tLearn how participants tolerate NOC-100\n•\tFind out how much NOC-100 is in the blood of healthy participants after taking the clinical trial investigational medicine.\n\nThis study consisting of 2 parts Part 1 will be a SAD (single ascending dose) investigation and Part 2 will be a MAD (multiple ascending dose) investigation, with both parts conducted in healthy adult subjects at a single clinical research unit (CRU) assessing the safety, tolerability, and PK (drug concentration in the body after administration) of inhaled doses of NOC 100.\nIn part 1 Up to 5 cohorts of 8 healthy adult subjects (6 active and 2 placebo(dummy drug)) are planned for evaluation. In each cohort, subjects will receive a single inhaled dose of NOC-100 or dose-level matched placebo by nebulizer on Day 1. And in part 2, Up to 5 cohorts of 8 healthy adult subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive multiple doses of NOC-100 or placebo by nebulizer beginning on Day 1 and dosing once daily for 7 days\n\n
REC name
HSC REC B
REC reference
20/NI/0066
Date of REC Opinion
9 Jun 2020
REC opinion
Favourable Opinion