Safety, Tolerability, PK and PD of DDA945 in Healthy Volunteers
Research type
Research Study
Full title
A randomized, placebo-controlled, first-in-human blinded study, to assess the safety, tolerability and pharmacokinetics of single and multiple ascending doses of inhaled DDA945 in healthy volunteer subjects.
IRAS ID
214091
Contact name
Muna Albayaty
Contact email
Sponsor organisation
Rhizen Pharmaceuticals SA
Eudract number
2016-003560-39
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
This is a randomised, placebo-controlled, first-in-human, blinded clinical trial to assess the safety, tolerability and pharmacokinetics of single and multiple doses of the Sponsor’s study medication, DDA945, in healthy volunteer subjects.
The study will consist of up to three parts. In each part, subjects will be allocated to one of several cohorts to allow the researchers to progressively increase the dose strength of the study drug (dose escalation) during the trial. In each cohort the majority of subjects will be randomised to receive the active study drug and a few will receive dummy study drug (placebo). The study drug will be inhaled from a dry powder inhaler. Subjects will receive training on how to use the inhaler. All study parts will include a screening visit, in-house treatment period at the Clinical Unit, outpatient visits and an end-of-study visit.
This will be the first time DDA945 is administered in humans. It is being developed by Rhizen Pharmaceuticals SA for treatment of severe asthma and other chronic respiratory diseases. The standard treatment available for asthma is not effective in all patients and symptoms are not adequately controlled in many sufferers. Therefore, new treatments are needed to improve outcomes for patients with severe/refractory asthma.
The main purpose of the study is to see how safe the drug is and how well the body tolerates the drug after single and multiple doses. The study will investigate how the drug is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body). The study will look at individual genetic variation and specific biomarkers to try to explain why patients react differently to the study medication; how the different dose strengths affect the QT interval of the heart; and whether there are substances (metabolites) in blood/urine formed during drug metabolism.
REC name
London - Riverside Research Ethics Committee
REC reference
17/LO/1284
Date of REC Opinion
11 Sep 2017
REC opinion
Further Information Favourable Opinion