A shot every few weeks? new drug tested for schizophrenia

NCT ID NCT07815210

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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