Phase I Trial of HHK101 in Patients With Schizophrenia

NCT07815210 | Not Yet Recruiting Phase 1

• 1 other identifier: HHK101-1
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Schizophrenia

Keywords

schizophrenia; pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Number of participants with Adverse events

  Adverse events

  Baseline through 18 weeks post-dose

• Drug Concentrations

  Concentrations assessed by pre-specified methods

  Baseline through 18 weeks post-dose

• 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.

  Baseline through 18 weeks post-dose

Study Arms (8)

HHK101 Single Dose 1

EXPERIMENTAL

Drug: HHK101

HHK101 Single Dose 2

EXPERIMENTAL

Drug: HHK101

HHK101 Single Dose 3

EXPERIMENTAL

Drug: HHK101

HHK101 Single Dose 4

EXPERIMENTAL

Drug: HHK101

HHK101 Single Dose 5

EXPERIMENTAL

Drug: HHK101

HHK101 Multiple Dose 1

EXPERIMENTAL

Drug: HHK101

HHK101 Multiple Dose 2

EXPERIMENTAL

Drug: HHK101

HHK101 Multiple Dose 3

EXPERIMENTAL

Drug: HHK101

Interventions

HHK101 DRUG

A single intramuscular injection of HHK101-Dose 1

HHK101 Single Dose 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Pregnant or lactating, or with a positive pregnancy test;
• With plan for pregnancy, sperm/ovum cryopreservation or donation, and refuse to use effective contraception from screening through 6 months after last dosing;
• With white blood cell ≤ 3 × 10⁹/L; neutrophil ≤ 1 × 10⁹/L; platelet ≤ 80 × 10⁹/L; hemoglobin ≤ 80 g/L; ALT ≥ 2 × ULN; AST ≥ 2 × ULN; total bilirubin ≥ 1.5 × ULN; CK ≥ 3 × ULN; serum creatinine ≥ 1.5 × ULN; triglycerides ≥ 3.0 mmol/L; glycated hemoglobin (HbA1c) ≥ 7.5 %; systolic blood pressure ≥ 160 mmHg or ≤ 90 mmHg; diastolic blood pressure ≥ 100 mmHg or ≤ 60 mmHg; heart rate ≤ 50 bpm or ≥ 110 bpm; QTcF \> 470 ms (female) / \> 450 ms (male); FT4 outside reference range; positive hepatitis B surface antigen; positive hepatitis C antibody; positive HIV antibody; positive syphilis serology test;
• Other conditions unsuitable for the trial judged by the investigator.

Sponsors & Collaborators

• Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.: lead

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Feng

  Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Liang Li

CONTACT

+8615800440760; liliang@hhkmed.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share