A Dose-Response Safety Study of ENX-102 in Patients With GAD

Engrail Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: General Anxiety Disorder

Treatments: Drug: Placebo; Drug: ENX-102

Study type: Interventional

Funder types: Industry

Identifiers

NCT06653296

ENX-102-004

Details and patient eligibility

About

This is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of ENX-102 and determine a dose-response for the effects of ENX-102 in patients with GAD

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male or female, inclusive of any gender identity, aged 18 to 65 years, inclusive
• Diagnosed with GAD according to the DSM-V, confirmed by MINI
• Experiencing clinically significant generalized anxiety as measured by HAM-A score ≥18 and at least moderately severe core symptoms of anxious mood and tension as measured by HAM-A Items 1 and 2, respectively, with scores each ≥2

Key Exclusion Criteria:

• Clinically predominant psychiatric diagnosis other than GAD per the MINI
• Any past/lifetime or current diagnosis of a neurocognitive disorder or psychotic disorder, or current posttraumatic stress disorder, obsessive compulsive disorder, or bipolar disorder
• Ingested prohibited medication within 5 half-lives prior to Day 1
• Current or recent moderate or severe substance use disorder as assessed by the MINI
• Unwilling or unable to abstain from alcohol or other recreational psychoactive substances such as marijuana during participation in the trial
• Has significant progressive disorders or unstable medical conditions
• Is unable to comply with the requirements of the study or, in the opinion of the Investigator, is unsuitable for the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

ENX-102 low-dose

Experimental group

Description:

ENX-102

Treatment:

Drug: ENX-102

ENX-102 mid-dose

Experimental group

Description:

ENX-102

Treatment:

Drug: ENX-102

ENX-102 high-dose

Experimental group

Description:

ENX-102

Treatment:

Drug: ENX-102