SchizophreniaPhase 1NCT07815210
Phase I Trial of HHK101 in Patients With Schizophrenia
A Phase 1 study testing HHK101-Single Dose 1, HHK101-Single Dose 2 and HHK101-Single Dose 3 in people with Schizophrenia, run by Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd. at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- HHK101-Single Dose 1, HHK101-Single Dose 2 and HHK101-Single Dose 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 4 sitesChina
- Study dates
- 15 Nov 2026to 31 Oct 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Hunan Brain Hospital (The Second People's Hospital of Hunan Province)
Changsha, Hunan, 410007
Ning Yuan, +8673185232203, 214723726@qq.com
Ning Yuan
Huzhou No.3 People's Hospital
Huzhou, Zhejiang, 313000
Xin Pan, +865722132466, huzhoupanxin@163.com
Xin Pan
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Huafang Li, +862134773107, hlh_5@163.com
Huafang Li
Xi'an Mental Health Center
Xi'an, Shaanxi, 710061
Yani Yang, +862963609241, Yanny9250@163.com
Yani Yang
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of HHK101 in Patients With Schizophrenia
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
- Being tested
- HHK101-Single Dose 1, HHK101-Single Dose 2, HHK101-Single Dose 3, HHK101-Single Dose 4, HHK101-Single Dose 5
- Keywords
- schizophrenia, pharmacokinetics
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HHK101-Single Dose 1Drug
A single intramuscular injection of HHK101-Dose 1
HHK101-Single Dose 2Drug
A single intramuscular injection of HHK101-Dose 2
HHK101-Single Dose 3Drug
A single intramuscular injection of HHK101-Dose 3
HHK101-Single Dose 4Drug
A single intramuscular injection of HHK101-Dose 4
HHK101-Single Dose 5Drug
A single intramuscular injection of HHK101-Dose 5
HHK101-Multiple Dose 1Drug
Three intramuscular injections of HHK101-Dose 1, every 4 weeks
HHK101-Multiple Dose 2Drug
Three intramuscular injections of HHK101-Dose 2, every 4 weeks
HHK101-Multiple Dose 3Drug
Two intramuscular injections of HHK101-Dose 3, every 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| HHK101 Single Dose 1 | Experimental | Not described Receives: Drug: HHK101-Single Dose 1 |
| HHK101 Single Dose 2 | Experimental | Not described Receives: Drug: HHK101-Single Dose 2 |
| HHK101 Single Dose 3 | Experimental | Not described Receives: Drug: HHK101-Single Dose 3 |
| HHK101 Single Dose 4 | Experimental | Not described Receives: Drug: HHK101-Single Dose 4 |
| HHK101 Single Dose 5 | Experimental | Not described Receives: Drug: HHK101-Single Dose 5 |
| HHK101 Multiple Dose 1 | Experimental | Not described Receives: Drug: HHK101-Multiple Dose 1 |
| HHK101 Multiple Dose 2 | Experimental | Not described Receives: Drug: HHK101-Multiple Dose 2 |
| HHK101 Multiple Dose 3 | Experimental | Not described Receives: Drug: HHK101-Multiple Dose 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse events
Adverse events
Measured: Baseline through 18 weeks post-dose
Drug Concentrations
Concentrations assessed by pre-specified methods
Measured: 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.
Measured: Baseline through 18 weeks post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start15 Nov 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Feng, Study director, Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815210
- Sponsor's protocol ID
- HHK101-1
- Status last verified
- Oct 2026
- First submitted
- 7 Sep 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The sponsor has not established an IPD sharing framework for early-phase pharmacokinetic trials.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of HHK101 in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT07815210
- Acronym / sponsor ID
- HHK101-1
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| HHK101 Single Dose 1 | Experimental | Drug: HHK101-Single Dose 1 |
| HHK101 Single Dose 2 | Experimental | Drug: HHK101-Single Dose 2 |
| HHK101 Single Dose 3 | Experimental | Drug: HHK101-Single Dose 3 |
| HHK101 Single Dose 4 | Experimental | Drug: HHK101-Single Dose 4 |
| HHK101 Single Dose 5 | Experimental | Drug: HHK101-Single Dose 5 |
| HHK101 Multiple Dose 1 | Experimental | Drug: HHK101-Multiple Dose 1 |
| HHK101 Multiple Dose 2 | Experimental | Drug: HHK101-Multiple Dose 2 |
| HHK101 Multiple Dose 3 | Experimental | Drug: HHK101-Multiple Dose 3 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HHK101-Single Dose 1A single intramuscular injection of HHK101-Dose 1 | Drug | HHK101 Single Dose 1 |
| HHK101-Single Dose 2A single intramuscular injection of HHK101-Dose 2 | Drug | HHK101 Single Dose 2 |
| HHK101-Single Dose 3A single intramuscular injection of HHK101-Dose 3 | Drug | HHK101 Single Dose 3 |
| HHK101-Single Dose 4A single intramuscular injection of HHK101-Dose 4 | Drug | HHK101 Single Dose 4 |
| HHK101-Single Dose 5A single intramuscular injection of HHK101-Dose 5 | Drug | HHK101 Single Dose 5 |
| HHK101-Multiple Dose 1Three intramuscular injections of HHK101-Dose 1, every 4 weeks | Drug | HHK101 Multiple Dose 1 |
| HHK101-Multiple Dose 2Three intramuscular injections of HHK101-Dose 2, every 4 weeks | Drug | HHK101 Multiple Dose 2 |
| HHK101-Multiple Dose 3Two intramuscular injections of HHK101-Dose 3, every 8 weeks | Drug | HHK101 Multiple Dose 3 |
Primary outcome
Number of participants with Adverse events
Time frame: Baseline through 18 weeks post-dose
Adverse events
Drug Concentrations
Time frame: Baseline through 18 weeks post-dose
Concentrations assessed by pre-specified methods
Changes from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Time frame: Baseline through 18 weeks post-dose
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No. The sponsor has not established an IPD sharing framework for early-phase pharmacokinetic trials.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Feng study director
Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HHK101-Single Dose 1, HHK101-Single Dose 2 and HHK101-Single Dose 3 in people with Schizophrenia, run by Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd. at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liang Li (+8615800440760, liliang@hhkmed.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse events (time frame: Baseline through 18 weeks post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.