RE104 Safety and Efficacy Study in Generalized Anxiety Disorder

Conditions

• Generalized Anxiety Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 74 Years

Healthy Volunteers

Not accepted

Interventions

• RE104 for Injection — DRUG
  Single, subcutaneous dose of RE104 for Injection
• Placebo — DRUG
  Single, subcutaneous dose of 0.9% sodium chloride for injection

Study Details

The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces anxiety symptoms in participants with Generalized Anxiety Disorder (GAD) as compared to placebo.

Key Dates

First listed

Mar 24, 2026

Start date

Apr 20, 2026

Status verified

May 2026

Primary completion

Feb 28, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

64 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  A single subcutaneous injection of 0.9% sodium chloride for injection
• Experimental: 30 mg RE104
  A single subcutaneous injection of 30 mg RE104 for Injection

Primary Outcome Measure

RE104 30 mg versus placebo change from Baseline at Week 4 in Hamilton Anxiety Rating Scale (HAM-A) total score [ Time Frame: Week 4 ]

Central Contacts

• Mark Pollack Chief Medical Officer, M.D.
  1-888-880-REUN
  [email protected]

Locations (28)

Find similar trials in Birmingham, AL

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