First in human study to assess the safety, tolerability and pharmacokinetics of EDI048
Research type
Research Study
Full title
A first-in-human, randomized, participant and investigator blinded, placebo controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of EDI048 in healthy volunteers
IRAS ID
1004992
Contact name
Sofia Perez Weigel
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2021-006567-19
ISRCTN Number
ISRCTN38693215
Research summary
The Sponsor is developing the test medicine, EDI048 for the potential treatment of cryptosporidiosis. Cryptosporidiosis is an infection caused by parasites that causes watery diarrhoea. These infections can be potentially life threatening in vulnerable populations.
This two-part healthy volunteer study will enrol approximately 64 males and females, aged between 18 and 55 (inclusive), in a non-NHS UK site, to assess the safety and tolerability of the test medicine.
Part A will consist of 4 groups (8 volunteers per group), who will be randomised (chosen at random) to receive a single dose of EDI048 or placebo (dummy test medicine).
Part B will consist of 4 groups (8 volunteers per group) who will be randomised to receive a single dose of EDI048 or placebo (dummy test medicine) every 12 hours for 5.5 days.
EDI048 or placebo (dummy test medicine) will be given as an oral liquid by mouth and each group will receive a higher dose than the previous group, providing the data shows it is safe to do so.
Volunteers will be discharged on Day 8 (Part A) and Day 13 (Part B). They will then receive a follow up phone call on 30 days post final dose.Volunteer’s blood and urine will be taken throughout the study for analysis of the test medicine and for their safety.
Volunteers are expected to be involved in this study for approximately 8.5 weeks (Part A) or 9 weeks (Part B) from screening to the follow up call.
REC name
London - London Bridge Research Ethics Committee
REC reference
22/LO/0107
Date of REC Opinion
22 Apr 2022
REC opinion
Further Information Favourable Opinion