Health Condition 1: F20- Schizophrenia
Conditions
Interventions
Intervention1: Aripiprazole Extended-Release Injectable
Suspension: Aripiprazole Extended-Release Injectable
Suspension, (HBT009
Test) 400 mg, for 4 months, injectables
Control Intervention1: ABILIFY MAINTENA®: ABILIFY MAINTENA®
400 mg, for 4 months, injectables
Sponsors
HBT Labs Inc
Eligibility
Inclusion criteria
Inclusion criteria: Male or female ages 18 through 65 years, both inclusive. 2) Subject diagnosed with schizophrenia and/or schizoaffective disorder as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for at least 1 year and clinically stable for the past 4 months (non-acute) in the investigator’s judgement and in the judgement of the treating psychiatrist if the subject is not an on-going subject of the investigator and based on the following objective criteria at the time of screening visit (Visit 1): Outpatient status during the entire 4-month period preceding the screening visit (Visit 1) ??Score of = 4 on the following Positive and Negative Syndrome Scale (PANSS) items •?Conceptual disorganization •?Hallucinatory behavior •Suspiciousness / persecution •Hostility •Unusual thought content A total score on the 5 PANSS items = 18 3) Subjects who have received documented treatment with at least three consecutive monthly intramuscular injection doses of ABILIFY MAINTENA® 400 mg into the deltoid or gluteal muscle in the 3 months immediately prior to the screening visit (up to Day - 21). Subject who received prior gluteal injections will receive one additional injection into the deltoid muscle. 4) Subject is on stable regimen of oral Aripiprazole 10-20 mg prior to screening, if not already on a stable monthly regimen of 400 mg of Aripiprazole Extended-Release Injectable Suspension. Such subject will receive at least three consecutive doses of 400 mg ABILIFY MAINTENA® every 28 days into the deltoid muscle before randomization. 5) Body mass index (BMI) = 18 kg/m2 at screening visit (Visit 1). PROTOCOL # HBT009 Protocol Version No.: 02 Date: 17 Mar 2021 Confidential Page 15 of 124 6) Eligible female subject will be: Non-pregnant, evidenced by serum HCG tests at screening. Non-lactating. Surgically sterile or postmenopausal, defined as at least 1 year of spontaneous amenorrhea prior to screening visit (Visit 1), or agree to continue to use an accepted method of birth control during the entire study and for at least 4 months after the last injection received in the study. Acceptable methods of birth control are: hormonal contraceptives; double barrier method; intrauterine device; surgical sterility for at least 6 months prior to screening visit (Visit 1) by tubal ligation; surgical sterility for at least 6 months prior to screening by hysterectomy and/or bilateral oophorectomy; and/or postmenopausal status (defined as at least 1 year without menses. Intended abstinence is not considered an acceptable method of birth control for this study; subject must agree to use an acceptable method of birth control while they become sexually active during the study or within 4 months after the last dose of study medication. 7) The subject and LAR must demonstrate adequate decision-making ability to make an informed choice about participating in this study by providing written informed consent. Subject must have an ability to communicate effectively with the investigator and other study center personnel and agree to comply with the st
Exclusion criteria
Exclusion criteria: Subject will not be eligible for inclusion in this study if any of the following criteria apply: 1) Treatment with a second antipsychotic that is any formulation of aripiprazole or a metabolite or pro-drug of aripiprazole (treatment with a second antipsychotic other than aripiprazole, an aripiprazole metabolite, or an aripiprazole pro-drug is not exclusionary). 2) Subject who has a concurrent primary psychiatric (by the DSM 5 criteria) diagnosis of intellectual development disorder and having dementia related psychosis. 3) Subject who has attempted suicide within 1 year prior to screening or that are at significant risk of a suicide attempt based on history or the investigators judgement as per C-SSRS scale. 4) Subject who has physically assaulted or acted substantially aggressive toward another person or animal or caused significant property damage due to aggressive behavior within 1 year prior to the screening visit (Visit 1) or that are at significant risk of such behaviors based on clinical interview. 5) History of a moderate or severe substance use disorder (including alcohol and excluding only tobacco-related use disorders [caffeine is not a substance that is subject to a diagnosis of substance use disorder in DSM-5]; mild substance use disorder is not exclusionary if in the opinion of the investigator the mild substance use disorder will not interfere with the potential subject’s ability to comply with protocol requirements) by DSM-5 criteria during the 6-month period immediately prior to screening or positive drug test at screening (Visit 1) and at randomization visit. 6) Subject is unwilling to abstain from grapefruit juice, pomelo juice, seville orange juice, and grape juice for at least 7 days prior to randomization visit and throughout the study prior to all clinical research unit (CRU) visits. Subject will be instructed to keep consumption of caffeine and caffeine-containing products consistent (e.g., do not decrease or increase their daily intake of caffeine). 7) Subject with a history of neuroleptic malignant syndrome or tardive dyskinesia. 8) Subject who has a concurrent primary neurological diagnosis of idiopathic Parkinson’s disease. 9) Subject who has any uncontrolled, unstable clinically relevant medical condition (e.g., cardiovascular, respiratory, hematologic, cerebrovascular, hepatic, renal, endocrine, immunologic or other medical condition), which in the judgment of the investigator and sponsor would interfere with the subjects ability to participate in the study. 10) Clinically significant new illness in the 1 month prior to screening visit (Visit 1) or any hospitalization for a medical or psychiatric condition within 4 months of the screening visit (Visit 1). 11) Subject who presents with any of the signs and symptoms of COVID- 19 such as fever or chills, cough, shortness of breath, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or sunny nose, nausea or vomiting, and diarrhea. 12) Subject with history of organ transplantation. 13) Malignancy within 5 years of the screening visit (Visit 1) (except for basal cell and squamous cell skin carcinoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the PK parameters that pertain to rate and extent of absorption of Aripiprazole extended-release injectable suspension (HBT009) 400 mg to ABILIFY MAINTENA® 400 mg in order to determine if these two formulations are bioequivalent (BE) after steady-state dosing Timepoint: 4 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the safety of multiple doses (four doses) of HBT009 400 mg to multiple doses (four doses) of ABILIFY MAINTENA® 400 mg. Safety assessment will be based on adverse events, vital signs, laboratory measurements (hematology, clinical chemistry, urinalysis), and electrocardiogram (ECG) results. •?Due to the potential clinical consequences of relapse of schizophrenia, any relapse or change in clinical status will be considered a safety objective. Timepoint: 4 Months | — |
Countries
India
Contacts
Public ContactSanjeev Sengar
Cliantha Research Limited
Outcome results
None listed