Evaluate Pharmacokinetics, Safety, and Tolerability of AX251 LAI in Patients With Schizophrenia

Sponsor
Anxo Pharmaceutical Co., Ltd.
Study ID
NCT07484204
Phase
PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • AX251 LAI 45 mg — DRUG
    Cariprazine 45 mg
  • AX251 LAI 90 mg — DRUG
    Cariprazine 90 mg
  • AX251 LAI 135 mg — DRUG
    Cariprazine 135 mg
  • AX251 LAI 180 mg — DRUG
    Cariprazine 180 mg

Study Details

The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of AX251 long-acting injectable (LAI) administered as a single dose in patients with schizophrenia. The study will include sequential dose-escalation cohorts to evaluate different dose levels of AX251 LAI.

Key Dates

First listed
Mar 20, 2026
Start date
Jul 31, 2026
Status verified
Mar 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AX251 LAI 45 mg
    AX251 LAI 45mg
  • Experimental: AX251 LAI 90mg
    AX251 LAI 90mg
  • Experimental: AX251 LAI 135mg
    AX251 LAI 135mg
  • Experimental: AX251 LAI 180mg
    AX251 LAI 180mg

Primary Outcome Measure

Pharmacokinetic Parameter [ Time Frame: Day 1 pre-dose and 1, 2, 3, 4, 8, 12, and 24 hours post-dose. Days 3, 5, 7, 14, 21, 28, 42, 56, and 70 ]

Central Contacts

Find similar trials

Nationwide
Schizophrenia trialsPsychiatry trialsMental health trialsBehavioral health trials

Related Studies