Generalized anxiety disorder (GAD) Mental and Behavioural Disorders
Conditions
Interventions
Participants will be randomised using an Interactive Response Technology (IRT) system to one of the three following treatment arms:
1. 25 mg NTX-1955
2. 15 mg NTX-1955
3. Placebo
Participants in each
Sponsors
Newleos Therapeutics
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18–55 years (inclusive). 2. Diagnosis: Generalised Anxiety Disorder (DSM-5-TR) confirmed by MINI, with symptoms for =6 months before screening. 3. Severity: HAM-A =20 at screening. 4. Contraception/pregnancy: Participants of childbearing potential agree to protocol-specified contraception/abstinence for the required period; negative pregnancy test at screening (and baseline/day 1 if applicable); not pregnant or breastfeeding. 5. Body size: BMI 18–35 kg/m² and weight =50 kg at screening. 6. Psychotherapy: Counselling/psychotherapy allowed if stable =4 weeks pre-Day 1 and expected to remain stable through Day 14; if not in therapy, agrees not to start until after Day 14 visit window. 7. Consent: Able and willing to provide written informed consent and comply with study requirements.
Exclusion criteria
Exclusion criteria: 1. Primary psychiatric disorder other than GAD that could interfere with study participation/outcomes (per MINI/investigator). 2. Psychotic disorder (lifetime/current), or current PTSD, OCD, or bipolar disorder. 3. Suicidality/safety risk: Recent significant suicidal ideation/behaviour per C-SSRS and/or investigator judges participant a safety risk. 4. Substance/alcohol: Moderate/severe alcohol or substance use disorder within 12 months (DSM-5/MINI), inability to comply with alcohol restrictions, or positive breath alcohol/urine drug screen at screening/baseline. 5. Prohibited concomitant meds: Use of prohibited medications within required washout; specifically moderate/strong CYP3A4 inhibitors/inducers (incl. St John’s Wort) within 28 days or 5 half-lives (whichever longer) before Day 1. 6. Recent investigational product exposure / excessive trial participation: Investigational drug within 60 days or 5 half-lives (whichever is longer) before Day 1; frequent participation as per protocol limits. 7. Clinically significant medical conditions or abnormal screening findings that increase risk or confound outcomes (including clinically significant abnormalities in labs, ECG, vitals, physical exam), per investigator. 8. Seizure risk/neurologic conditions: Epilepsy/seizure disorder (except uncomplicated febrile convulsions) or neurologic history likely to increase seizure risk or interfere with EEG readouts (e.g., significant TBI, stroke, encephalopathy). 9. Hepatic impairment: Liver enzymes or bilirubin >1.5× ULN. 10. Infections: Positive HBV, HCV, or HIV screening tests. 11. Hypersensitivity/allergy: Known hypersensitivity to benzodiazepines (and other clinically significant allergy/anaphylaxis history as relevant).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and tolerability of NTX-1955 measured by the incidence and severity of treatment-emergent adverse events from the first dose until the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| The pharmacokinetics of NTX-1955 measured by the plasma concentrations of NTX-1955 (optionally, a potential metabolite M5) on Day 1, Day 7 and Day 14 | — |
Countries
United Kingdom
Outcome results
None listed