NCT07185815

Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine

A Prospective, Dose Escalating, Open Label, Multi-center, Phase I/IIa Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Mapi Pharma Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the PK, Safety, Tolerability (all cohorts) and Efficacy (cohort 3), of once-a-month long-acting SC injection of dose escalating Cariprazine Depot in subjects eligible for treatment with oral Cariprazine.

Conditions

• Major Depressive Disorder (MDD)
• Bipolar 1 Disorder
• Schizophrenia

Interventions

Type	Name	Description
DRUG	Cariprazine Depot	One single dose of 22 mg
DRUG	Cariprazine Depot	One single dose of 44 mg
DRUG	Cariprazine Depot MTD	Three monthly doses of MTD (maximum tolerated dose)
DRUG	Oral Cariprazine 3 mg/day	Oral Cariprazine 3 mg/day for three months

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-12-31
• Completion: 2027-06-03
• First posted: 2025-09-22
• Last updated: 2026-04-16

Locations

5 sites across 2 countries: India, Israel