Ph 1 FiH - To Assess Safety, Tolerability & PK of AZD7798
Research type
Research Study
Full title
A Phase 1 Randomised, Double-Blind, Placebo-Controlled Study to assess the Safety, Tolerability and Pharmacokinetics of AZD7798 following Single Ascending Dose Administration to Healthy Subjects
IRAS ID
1005523
Contact name
Marnie Duncan
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2022-001438-12
Clinicaltrials.gov Identifier
Research summary
Research Summary:
This clinical trial will recruit healthy males and females (of childbearing and non-childbearing potential) between the ages of 18 and 50 years inclusive. A total of approximately 64 participants will take part in the clinical trial.
The new medicine tested in this clinical trial is a compound called AZD7798 this will be administered (received) either in the form of an infusion through a vein (IV) or subcutaneously (SC) (under the skin) . The Sponsor is developing the clinical trial medicine for treating Crohn’s disease.
The clinical trial medicine works by reducing the immune reaction that causes inflammation in the digestive tract (bowels). This inflammation triggers the signs and symptoms of Crohn’s disease.
The clinical trial consists of a Screening Visit, a Treatment Period (in-house stay), 5 ambulatory (outpatient) visits and a Follow-up Visit. Please note that the Screening procedures can be completed during more than one visit, if necessary.For the Treatment Period, Participants will be admitted to the Unit in the morning on the day before dosing (Day 1) and be required to stay in the Unit for 9 days and 8 nights. Participants will be dosed on Day 1 and have assessments performed until 7 days after dosing. Participants will be discharged from the Unit on Day 8 if the Clinical Trial Doctor is satisfied that you are in good health.
Participants will return to the Unit for the ambulatory visits on Days 15, 22, 29, 43 and 57 for further assessments.
Participants will return for a Follow up Visit on Day 85.Lay summary of results:
https://www.astrazenecaclinicaltrials.com/study/D7860C00001REC name
London - West London & GTAC Research Ethics Committee
REC reference
22/LO/0302
Date of REC Opinion
24 Jun 2022
REC opinion
Further Information Favourable Opinion