Safety, Tolerability and PK of anle138b in Healthy Subjects(QSC203238)
Research type
Research Study
Full title
A First-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetics of anle138b in Healthy Male and Female Subjects
IRAS ID
273362
Contact name
Dr. Johannes Levin
Contact email
Sponsor organisation
MODAG GmbH
Eudract number
2019-004218-33
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
The Sponsor, MODAG GmbH, is developing the test medicine, anle138b, for the potential treatment of neurodegenerative diseases such as Parkinson’s disease and multiple system atrophy. Symptoms of these include involuntary shaking of particular parts of the body (tremor), slow movement and stiff and inflexible muscles. These often cause a wide range of other physical and physiological symptoms such as depression, anxiety and problems sleeping.
The study will try to identify the safety and tolerability of single (part 1) and multiple ascending doses (part 2) of the test medicine in healthy volunteers. It will also try to identify how the test medicine is taken up by the body (pharmacokinetics). Optional part 3 will assess the effect of food on the pharmacokinetics of the test medicine.
The study will consist of up to 3 parts involving up to 92 healthy male and female volunteers [of non-childbearing potential]. In Part 1, up to 48 volunteers in up to 6 separate cohorts will receive a single oral dose of test medicine or matching placebo (dummy drug). In Part 2, up to 32 volunteers in up to 4 separate cohorts will receive multiple ascending oral doses of test medicine or matching placebo, given once daily for 7 days. In the optional Part 3, up to 12 volunteers will be enrolled into a single cohort, receiving the test medicine in the fasted and fed state to evaluate the effect of food on the pharmacokinetics of the test medicine.
In Parts 1 and 3 volunteers will remain in clinic for up to 48 hours post-dose. In Part 2, volunteers will remain in clinic until Day 9 (48 hours post-final dose). Volunteers will return to the clinical for a follow-up visit 5 to 7 days post-dose.
REC name
Wales REC 2
REC reference
19/WA/0327
Date of REC Opinion
30 Nov 2019
REC opinion
Further Information Favourable Opinion