A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Efficacy of NTX-1472, a V1a Receptor Antagonist, in Adults With Social Anxiety Disorder
Newleos Therapeutics, Inc.
Summary
The primary goal of this Phase 2 clinical trial is to determine the effects of a novel V1a receptor antagonist (NTX-1472) in adults with Social Anxiety Disorder (SAD). The main questions this trial aims to answer are: * Is NTX-1472 safe and well tolerated in adults with SAD? * How effectively does NTX-1472 treat adults with SAD? Researchers will compare the effects of NTX-1472 with matching placebo (a look-alike capsule that contains no drug). Participants will: * Take NTX-1472 or matching placebo every day for 8 weeks * Visit the clinic 6 times over the course of 14 weeks for checkups and tests
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria * Has provided written informed consent for the study and is willing to comply with all requirements of the protocol * English speaker * Male or female, ≥18 and ≤65 years of age * Current diagnosis of generalized Social Anxiety Disorder (SAD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) and confirmed by the Structured Clinical Interview for DSM-5 (SCID-5-CT). * Clinician-administered Liebowitz Social Anxiety Score (LSAS) total score ≥70 at Screening * Clinician-rated Hamilton Depression Rating Scale (HDRS 17) (17 items) to…
Interventions
- DrugNTX-1472
Daily (QD) x 8 weeks.
- DrugPlacebo
Daily (QD) x 8 weeks.
Locations (11)
- SOAR Clinical Study SitePheonix, Arizona
- SOAR Clinical Study SiteEncino, California
- SOAR Clinical Study SiteLos Angeles, California
- SOAR Clinical Study SiteOceanside, California
- SOAR Clinical Study SiteSan Jose, California
- SOAR Clinical Study SiteJacksonville, Florida