Trials / Active Not Recruiting
Active Not RecruitingNCT06245213
A Study of ANAVEX3-71 in Adults With Schizophrenia
A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Electrophysiology of ANAVEX3-71 in Adult Patients With Schizophrenia in a Multiple Ascending Dose Study (Part A), Followed by a Double-Blind, Randomized, Placebo-Controlled Study (Part B)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 71 (actual)
- Sponsor
- Anavex Life Sciences Corp. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
A study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and electrophysiology of ANAVEX3-71 in patients with Schizophrenia.
Detailed description
ANAVEX3-71-SZ-001 is a two-part study. The first part is Part A: Multiple Ascending Dose, PK, safety, and dose selection. The second part is Part B: Double Blind, Placebo Controlled for exploratory efficacy and continued repeat-dose safety. This study will investigate the effects of ANAVEX3-71 in patients with Schizophrenia for the first time. This is an in-patient study. In both parts, participants will undergo either 10 or 28 days of dosing (Part A and Part B, respectively). Standard clinical outcome measures used in the clinic and novel fluid and electrophysiological biomarkers will also be assessed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ANAVEX3-71 oral capsules | ANAVEX®3-71 (formerly AF710B) is a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator with agonistic effects. This novel mechanism of action offers the potential to treat all symptom domains (positive, negative, and cognitive) of schizophrenia without the side effects of standard of care antipsychotics. |
| DRUG | Placebo oral capsules | The placebo comparator for the study. |
Timeline
- Start date
- 2024-03-15
- Primary completion
- 2025-06-30
- Completion
- 2025-06-30
- First posted
- 2024-02-07
- Last updated
- 2025-05-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06245213. Inclusion in this directory is not an endorsement.