A shot every few weeks? new drug tested for schizophrenia
NCT ID NCT07815210
First seen Sep 11, 2026 · Last updated Sep 11, 2026
Summary
Researchers are testing HHK101, an experimental injectable drug, in adults with stable schizophrenia. The trial measures how the body absorbs the drug, tracks side effects, and looks for changes in symptom scores. Participants receive one or more intramuscular injections at different doses and schedules.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HHK101, an experimental injectable antipsychotic drug
- What this could lead to
- If it works, HHK101 could offer a long-acting injectable option for people with schizophrenia, given every few weeks instead of daily pills.
- What could go wrong
- This is a first-in-human Phase I trial, so researchers mainly test safety and dosing. The drug may cause side effects, may not ease symptoms, and any benefit seen in a small group may not hold in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 125 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2026
An estimate. Start dates often move.
- Expected to finish
-
Oct 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Schizophrenia are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Scientists probe brain's reward system in mental illness
- New schizophrenia drug targets brain glutamate, not dopamine
- New drug candidate takes aim at schizophrenia symptoms
- New schizophrenia drug goes Head-to-Head with standard antipsychotics in Long-Term trial
- Five-Year safety check for experimental schizophrenia drug
- Could a Once-a-Week antipsychotic pill change schizophrenia care?