100 Participants Needed

NTX-1472 for Social Anxiety Disorder

(SOAR Trial)

NT
Overseen ByNewleos Therapeutics Clinical Trial Team
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Newleos Therapeutics, Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

Adults aged 18-65 with a confirmed diagnosis of generalized Social Anxiety Disorder (SAD) as per DSM-5, who can speak English and have a moderate to severe level of social anxiety. They must not be significantly depressed and agree to use effective birth control if capable of childbearing.

Inclusion Criteria

I meet the main requirements to join the study.
I speak English.
I have signed the consent form and agree to follow the study rules.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take NTX-1472 or matching placebo every day for 8 weeks

8 weeks
6 visits (in-person) over 14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NTX-1472

Trial Overview

The trial is testing NTX-1472, a new drug for treating SAD by blocking V1a receptors. Over 8 weeks, participants will take either NTX-1472 or placebo daily and visit the clinic six times for checkups. The study aims to assess safety, tolerability, and effectiveness in reducing social anxiety symptoms.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: NTX-1472Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Newleos Therapeutics, Inc.

Lead Sponsor