Health TrialsbyHealthPanel

Phase I Trial of HHK101 in Patients With Schizophrenia

ConditionSchizophrenia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorZhuhai Huahaikang Pharmaceutical Technology Co., Ltd.

About this trial

This study aims to learn how the study drug is absorbed by the body, check for possible side effects, and see if the drug may help improve symptoms in patients with schizophrenia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily provide written informed consent by the participant and his/her legal representative;

Aged 18-65 years, weight ≥ 45 kg, body mass index 19-35 kg/m², male or female;

Diagnosed with stable schizophrenia, with 1 antipsychotic agent at a stable dose for ≥ 4 weeks before screening;

Positive and Negative Syndrome Scale (PANSS) total score ≤ 80, with each positive sub-scale item score < 5.

Disqualifiers

history of allergies to ≥3 different substances, or active allergic disease;

Past history of neuroleptic malignant syndrome or with current medical conditions including heart failure, acute coronary syndrome, stroke, orthostatic hypotension, dementia, Parkinson's disease, epilepsy, tardive dyskinesia, etc;

Received any investigational product within 12 weeks before screening;

Received strong/moderate inhibitors or inducers of CYP3A4 or CYP2D6 enzymes, or traditional Chinese medicines within 1 week before dosing;

Trial design

Design model

Parallel

Treatments tested in this trial

  • HHK101

    Drug

    A single intramuscular injection of HHK101-Dose 1

  • HHK101

    Drug

    A single intramuscular injection of HHK101-Dose 2

  • HHK101

    Drug

    A single intramuscular injection of HHK101-Dose 3

  • HHK101

    Drug

    A single intramuscular injection of HHK101-Dose 4

  • HHK101

    Drug

    A single intramuscular injection of HHK101-Dose 5

  • HHK101

    Drug

    Three intramuscular injections of HHK101-Dose 1, every 4 weeks

  • HHK101

    Drug

    Three intramuscular injections of HHK101-Dose 2, every 4 weeks

  • HHK101

    Drug

    Two intramuscular injections of HHK101-Dose 3, every 8 weeks

Treatment groups

125 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: HHK101 Single Dose 1Experimental treatment 1 intervention
Group B: HHK101 Single Dose 2Experimental treatment 1 intervention
Group C: HHK101 Single Dose 3Experimental treatment 1 intervention
Group D: HHK101 Single Dose 4Experimental treatment 1 intervention
Group E: HHK101 Single Dose 5Experimental treatment 1 intervention
Group F: HHK101 Multiple Dose 1Experimental treatment 1 intervention
Group G: HHK101 Multiple Dose 2Experimental treatment 1 intervention
Group H: HHK101 Multiple Dose 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with Adverse events

Adverse events

Time frame
Baseline through 18 weeks post-dose
2

Drug Concentrations

Concentrations assessed by pre-specified methods

Time frame
Baseline through 18 weeks post-dose
3

Changes from baseline in Positive and Negative Syndrome Scale (PANSS) total score

PANSS includes 30 items (7 items for positive symptoms, 7 items for negative symptoms, and 16 items for general psychopathology symptoms), and each item ranges from 1 to 7. The PANSS total score is a sum of scores from all items, ranging from 30 to 210, where a higher score represents severer psychotic symptoms in patients with schizophrenia.

Time frame
Baseline through 18 weeks post-dose

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: