Hallucinations and Delusions Associated With Alzheimer's Disease PsychosisPhase 1NCT06388551
A Phase 1, SAD Study to Evaluate the Safety and Tolerability of LY03017
A Phase 1 study testing LY03017 in people with Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis and Hallucinations and Delusions Associated With Parkinson Disease Psychosis, run by Luye Pharma Group Ltd. at 1 site in China.
Trial summary
This is a phase 1，randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and pharmacokinetics of oral LPM526000133 Fumarate Capsules (LY03017) in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis, Hallucinations and Delusions Associated With Parkinson Disease Psychosis, Negative Symptoms of Schizophrenia
- What is being tested?
- LY03017
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2024to 30 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject who voluntarily participate and sign the informed consent form.
- Healthy male/female volunteers aged ≥18 and ≤ 45 years.
- Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) ≥18.5 and < 26.0 kg/m2.
- Able to comply with the lifestyle restrictions.
Who cannot join
- Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution.
- Subject has a current or past medical history that may affect the clinical trial or dysfunction, including but not limited to the past or current respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, motor system, blood system, psychiatry/ psychology, dermatology and other clinically serious diseases or chronic diseases; or any other diseases that may interfere with the test results.
- Any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects.
- Subject has a history of surgery within 3 months prior to administration, or failure to recover from surgery, or having an expected surgical plan during the trial.
- Subject has abnormal vital signs, laboratory abnormalities, and ECGs.
- Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing.
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- Subject positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis seroreactivity (Trust).
- Subject has a history of alcohol abuse within 1 year or positive alcohol breath test results.
- Subject has a history of substance abuse within 1 year or a positive urine drug screen.
- Subject who has daily smoking of ≥ 5 cigarettes within 3 months.
- Subject who has special requirements for food, cannot comply with the unified diet or have dysphagia.
- Subject who has consumption of special diet (such as grapefruit, chocolate, coffee, xanthine-rich foods/drinks) within 48 hours prior to dosing and/or subject who has excessive daily consumption of tea, coffee, grapefruit juice, caffeinated beverages for nearly 3 months.
- Subject who has participated in other clinical trials within 3 months before administration.
- Subject has used blood products or being blood donor or blood loss within 3 months.
- Pregnant, lactating women, or positive pregnancy test.
- Subject who refusal to contraception, or plan to donate sperm or ovums.
- Subject who has a history of needle or blood faintness.
- Subject directly involved in this clinical trial.
- Poor compliance or other conditions which would make participation in the study unsuitable.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, SAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral LPM526000133 Fumarate Capsules (LY03017) in Healthy Adult Subjects.
This is a phase 1，randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and pharmacokinetics of oral LPM526000133 Fumarate Capsules (LY03017) in healthy adult subjects.
- Conditions
- Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis, Hallucinations and Delusions Associated With Parkinson Disease Psychosis, Negative Symptoms of Schizophrenia
- Being tested
- LY03017, LY03017-Placebo
- Medical subject headings
- Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY03017Drug
Also called LPM526000133 Fumarate Capsules
single dose, administered orally
LY03017-PlaceboDrug
single dose, administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY03017 | Experimental | Ascending single oral doses of LY03017 in healthy adult subjects Receives: Drug: LY03017 |
| Placebo | Placebo comparator | LY03017-Placebo Receives: Drug: LY03017-Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Measured: up to 216 hours
Secondary outcomes (5)
Maximum observed concentration (Cmax) of LPM526000133 in plasma
Measured: up to 216 hours
Time to maximum observed concentration (Tmax) of LPM526000133 in plasma
Measured: up to 216 hours
The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM526000133 in plasma
Measured: up to 216 hours
Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of LPM526000133 in plasma
Measured: up to 216 hours
Apparent terminal elimination half-life (t1/2) of LPM526000133 in plasma
Measured: up to 216 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start10 May 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallucinations and Delusions Associated With Alzheimer's Disease PsychosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388551
- Sponsor's protocol ID
- LY03017/CT-CHN-101
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, SAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral LPM526000133 Fumarate Capsules (LY03017) in Healthy Adult Subjects.
- ClinicalTrials.gov ID
- NCT06388551
- Acronym / sponsor ID
- LY03017/CT-CHN-101
- Conditions
- Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis, Hallucinations and Delusions Associated With Parkinson Disease Psychosis, Negative Symptoms of Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 May 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 29 Apr 2024 (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 is a phase 1，randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and pharmacokinetics of oral LPM526000133 Fumarate Capsules (LY03017) in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY03017 | Experimental | Drug: LY03017Ascending single oral doses of LY03017 in healthy adult subjects |
| Placebo | Placebo comparator | Drug: LY03017-PlaceboLY03017-Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject who voluntarily participate and sign the informed consent form.
- Healthy male/female volunteers aged ≥18 and ≤ 45 years.
- Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) ≥18.5 and < 26.0 kg/m2.
- Able to comply with the lifestyle restrictions.
Key exclusion criteria (19 listed)
- Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution.
- Subject has a current or past medical history that may affect the clinical trial or dysfunction, including but not limited to the past or current respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, motor system, blood system, psychiatry/ psychology, dermatology and other clinically serious diseases or chronic diseases; or any other diseases that may interfere with the test results.
- Any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects.
- Subject has a history of surgery within 3 months prior to administration, or failure to recover from surgery, or having an expected surgical plan during the trial.
- Subject has abnormal vital signs, laboratory abnormalities, and ECGs.
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 |
|---|---|---|
| LY03017Also: LPM526000133 Fumarate Capsulessingle dose, administered orally | Drug | LY03017 |
| LY03017-Placebosingle dose, administered orally | Drug | Placebo |
Primary outcome
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: up to 216 hours
5 secondary outcomes
Maximum observed concentration (Cmax) of LPM526000133 in plasma
Time frame: up to 216 hours
Time to maximum observed concentration (Tmax) of LPM526000133 in plasma
Time frame: up to 216 hours
The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM526000133 in plasma
Time frame: up to 216 hours
Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of LPM526000133 in plasma
Time frame: up to 216 hours
Apparent terminal elimination half-life (t1/2) of LPM526000133 in plasma
Time frame: up to 216 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY03017 in people with Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis and Hallucinations and Delusions Associated With Parkinson Disease Psychosis, run by Luye Pharma Group Ltd. at 1 site 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 19 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: status not confirmed, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huafang Li (+8618017311256 ext. 021-34773107, lhlh_5@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (time frame: up to 216 hours). 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 29 Apr 2024.