A Phase 1b Multicentre Trial of NTX-1955 in Adults with Generalised Anxiety Disorder
Research type
Research Study
Full title
A multicentre, double-blind, randomised, placebo-controlled trial to evaluate safety and tolerability of NTX-1955 in adult patients with Generalised Anxiety Disorder (GAD)
IRAS ID
1013090
Contact name
Federico Bolognani
Contact email
Sponsor organisation
Newleos Therapeutics
ISRCTN Number
18346744
Research summary
The aim of this study is to test the safety of an investigational drug called NTX-1955 in adult patients (ages 18-55) with Generalised Anxiety Disorder (GAD). NTX-1955 has not been approved for use outside of a research study. NTX-1955 has been tested in healthy volunteers and has been shown to be well tolerated. This study is now being conducted to test the safety and tolerability of NTX-1955 in a small group of patients with GAD.
Researchers will compare the effects of treatment with NTX-1955 to a placebo (a look-alike substance that contains no drug).
Participants enrolled in this study will need to take a capsule with either a low dose of NTX-1955 or a high dose of NTX-1955 or a placebo once every day for two weeks. Before patients can be enrolled they will need to attend a screening visit to ensure they are suitable to take part in the study. Following the screening visit, participants will also need to visit the clinic a further 5 times for check-ups and tests. It is planned to enrol 30 patients with GAD at up to 4 sites (3 sites with one back-up) in the United Kingdom. This study is being funded by the Sponsor, Newleos Therapeutics.REC name
Wales REC 1
REC reference
25/WA/0291
Date of REC Opinion
9 Dec 2025
REC opinion
Further Information Favourable Opinion