A Study of NTX-1472 in Social Anxiety Disorder

Part of paid clinical trials in Pheonix, Arizona.

Sponsor
Newleos Therapeutics, Inc.
Study ID
NCT07323784
Phase
PHASE2
Status
Recruiting

Conditions

  • Social Anxiety Disorder (SAD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • NTX-1472 — DRUG
    Daily (QD) x 8 weeks.
  • Placebo — DRUG
    Daily (QD) x 8 weeks.

Study Details

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

Key Dates

Start date
Dec 9, 2025
Status verified
Jan 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NTX-1472
  • Placebo Comparator: Placebo

Primary Outcome Measure

Incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline to Week 8 ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
SOAR Clinical Study SitePheonixArizona85012
SOAR Clinical Study Site
978-780-5937
SOAR Clinical Study SiteEncinoCalifornia91316
SOAR Clinical Study Site
978-780-5937
SOAR Clinical Study SiteLos AngelesCalifornia90025
SOAR Clinical Study Site
978-780-5937
SOAR Clinical Study SiteOceansideCalifornia92056
SOAR Clinical Study Site
978-780-5937
SOAR Clinical Study SiteSan JoseCalifornia95124
SOAR Clinical Study Site
978-780-5937
SOAR Clinical Study SiteJacksonvilleFlorida32256
SOAR Clinical Study Site
978-780-5937
SOAR Clinical Study SiteTampaFlorida33615
SOAR Clinical Study Site
978-780-5937
SOAR Clinical Study SiteBostonMassachusetts02131
SOAR Clinical Study Site
978-780-5937
SOAR Clinical Study SiteBrooklynNew York11229
SOAR Clinical Study Site
978-780-5937
SOAR Clinical Study SiteMemphisTennessee38119
SOAR Clinical Study Site
978-780-5937
SOAR Clinical Study SiteAustinTexas78737
SOAR Clinical Study Site
978-780-5937

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