Dyskinesia, Medication-inducedPhase 1KORA-LID-1NCT07905976
Safety and Tolerability of Single and Repeated Dose of IMM02-KORA in PD-associated Dyskinesia
A Phase 1 study testing IMM02-KORA in people with Dyskinesia, Medication-induced and Dyskinesia, Drug-Induced, run by Immunis, Inc..
Trial summary
The goal of this clinical trial is to test Safety and tolerability of single and repeated dose of IMM02-KORA in subjects with PD-associated dyskinesia. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Dyskinesia, Medication-induced, Dyskinesia, Drug-Induced
- What is being tested?
- IMM02-KORA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 30 Dec 2027
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject presents with a diagnosis of idiopathic Parkinson's disease
- PD subjects taking stable doses of IR levodopa for at least 4 weeks before Screening Visit
- The dose of levodopa and all PD drugs used during the trial anticipated to remain unchanged throughout the duration of the trial.
- The patient must present symptomatic levodopa induced dyskinesias that is predictable (peak-dose dyskinesia) and is not troublesome, as assessed by the investigator
- The patient did not start taking anti-dyskinetic medication, however, is qualified to start anti-dyskinetic medication based on investigator's assessment
- The subject shows adequate compliance with the schedule of the trial visits, admission in the hospital for the PK study, and the completion of the self-evaluation with Hauser diary.
Show all 11Show fewer
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- In order to understand the nature of this study it is expected that most participants will be able to speak, read, and understand English. However, additional translations of the informed consent may be made available after study initiation to include additional languages for participants
- Study participant must have the capacity and willingness to comply with contraception requirements.
- Study participant is willing and able to comply with all study requirements, according to the judgment of the Investigator.
- To be eligible for enrollment in phase Ia and Ib and for each treatment administration in phase Ia, vital signs should be in the following ranges: Heart rate >50 and <100 bpm, Systolic pressure >100 and <180 mmHg, Diastolic pressure >50 and <100 mmHg, Blood oxygenation (by pulse-oximetry) >95%. If the vitals are outside of the range, they will be reassessed 3 times at 10 minutes resting intervals and the investigator will decide the course of action including reassessment of the vitals, or excluding enrollment.
Who cannot join
- Unmanaged/uncontrolled comorbidities, including current clinically significant gastro intestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease, acute gastric/duodenal ulcer, hypertension that is not well controlled, asthma, chronic obstructive pulmonary disease (COPD), and unstable Type I diabetes. Subjects with a history of gastric/duodenal ulcer who have not had a recent episode of acute gastritis and are not currently experiencing gastric pain will be eligible for inclusion.
- Neoplastic disorder, which is either currently active or has been in remission for less than one year.
- Patients with severe renal or hepatic impairment.
- Concomitant disease likely to interfere with trial medication (e.g. capable of altering absorption, metabolism, or elimination of the trial drug).
- The subject has any clinically significant illness that, in the Investigator's opinion, might interfere with the subject's ability to participate in the trial.
- The subject is suffering from any cognitive decline, dementia or other psychiatric illness that prevents him/her from giving informed consent or will not allow the determination of trial outcomes
Show all 17Show fewer
- Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
- Female subject that is pregnant or lactating.
- The subject is experiencing exclusively diphasic, off-state, myoclonic, dystonic, or akathitic dyskinesias without peak dose dyskinesia.
- The subject has received neurosurgical intervention related to PD or slow-release implants (e.g. deep brain stimulation, thalamotomy, focused ultrasound therapy, continuous levodopa-carbidopa intestinal gel infusion, continuous subcutaneous apomorphine infusion, etc) or is scheduled to do so during the trial period.
- Patients that started to take anti-dyskinetic medication
- Patients taking prohibited medication as provided in Table 7 (Prohibited medications).
- The subject has legal incapacity or limited legal capacity.
- Study participant has been exposed to an investigational drug within 90 days, prior to the first dose of IMP, or is currently participating or planning to participate in another study of an investigational drug.
- Subjects with current diagnosis of substance abuse (DSM-IV) or history of alcohol or drug abuse in the past three months.
- Smoking or vaping products containing nicotine, tobacco or any other products, currently and in the past 1 year.
- Patients that manifested DLTs at any dose level during phase Ia will be excluded from the PK and repeated dose studies (Ib).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to test Safety and tolerability of single and repeated dose of IMM02-KORA in subjects with PD-associated dyskinesia.
Read the detailed description
The proposed study will assess the safety of IMM02-KORA (nalfurafine hydrochloride) - a selective kappa opioid receptor agonist - and will comprise two phases. The first phase (Ia) will aim to establish safety and tolerability by an accelerated dose titration approach, concomitant with pharmacokinetic (PK) studies. The second phase (Ib) will aim to establish a safe dosing regimen for repeated administration based on the previously determined PK parameters.
- Being tested
- IMM02-KORA
- Keywords
- Immunis, Immunis, Inc., Dyskinesia, PARKINSON'S DISEASE-ASSOCIATED DYSKINESIA, KORA-LID, KORA-LID-1
- Medical subject headings
- Dyskinesia, Drug-Induced, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM02-KORADrug
Also called TRK-820, MT-9938, AC-820, KORA
IMM02-KORA (nalfurafine hydrochloride) is a synthetic selective kappa opioid receptor agonist (KORA).
| Study group | Role | What they receive |
|---|---|---|
| IMM02-KORA 1a and PK | Experimental | Phase Ia will be a single oral dose accelerated titration administered at assumed clearance intervals. The doses will escalate in 2.5µg increments (2.5, 5.0, 7.5, 10.0, 12.5µg) p.o., daily. Titration will continue until at least one participant responds positively, which will define the minimum inhibiting dose (MID) of dyskinesia symptoms. After a dose limiting toxicity (DLT), the accelerated titration will convert into a 3+3 design, enrolling 3 additional participants at the same dose. If additional DLTs occur, that dose will be considered the maximum tolerated dose (MTD). If MTD is reached and fewer than 2 of 6 participants respond positively, a MID will not have been defined and the trial will stop.
The PK study will start one week after the last administered dose while participants are monitored for AEs. For the PK study, 3 participants without DLTs will be admitted to the hospital for 3 days, at least 7 days after their previous IMM02-KORA dose. Receives: Drug: IMM02-KORA |
| IMM02-KORA 1b | Experimental | The phase Ib will start after completion of PK study. For this part, additional 10 patients will be enrolled to take a repeated dose of IMP medication with the appropriate size and frequency for 4 weeks total duration, followed by additional 4 weeks of observations in the absence of the IMP administration. Receives: Drug: IMM02-KORA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (TEAEs) and DLT
Safety and tolerability of single increasing IMM02-KORA doses
Measured: baseline up to 15 weeks
Secondary outcomes (14)
Obtain information on a minimum inhibitory dose (MID) on peak dose dyskinesia and evaluate initial efficacy of repeated administration on peak dose dyskinesia
Determined by change from baseline of Abnormal Involuntary Movements Scale (AIMS). AIMS is 12-item scale scored by an observer to measure dyskinesia severity. Seven items are scored from 0-4 with zero being no dyskinesia observed and 4 being severe dyskinesia. Higher scores indicate a worse outcome.
Measured: baseline up to 15 weeks
Obtain information on a minimum inhibitory dose (MID) on peak dose dyskinesia and evaluate initial efficacy of repeated administration on peak dose dyskinesia
Determined by change from baseline of Hauser motor symptom diary
Measured: baseline up to 15 weeks
Obtain PK parameters necessary to calculate a repeated dose regimen
Determined by obtaining information on Cmax of IMM02-KORA in serum.
Measured: baseline up to 15 weeks
Obtain PK parameters necessary to calculate a repeated dose regimen
Determined by obtaining information on Tmax of IMM02-KORA in serum.
Measured: baseline up to 15 weeks
Obtain PK parameters necessary to calculate a repeated dose regimen
Determined by obtaining information on T1/2 of IMM02-KORA in serum.
Measured: baseline up to 15 weeks
Obtain PK parameters necessary to calculate a repeated dose regimen
Determined by obtaining information on area under the plasma concentration versus time curve (AUC) of IMM02-KORA in serum.
Measured: baseline up to 15 weeks
Obtain PK parameters necessary to calculate a repeated dose regimen
Determined by calculating a dose size and interval of administration that maintain a MID serum concentration
Measured: baseline up to 15 weeks
Obtain information on treatment interference with neurotransmitters
Determined by change from pre-administration of serum dopamine, norepinephrine, epinephrine, and serotonin
Measured: baseline up to 15 weeks
Obtain information on treatment interference with neurotransmitters
Determined by change from baseline of pre-administration of testosterone, FSH and LH levels
Measured: baseline up to 15 weeks
Evaluate initial efficacy of repeated administration on peak dose dyskinesia
Determined by post-treatment change from baseline of Abnormal Involuntary Movements Scale (AIMS) during the 1b portion. AIMS is 12-item scale scored by an observer to measure dyskinesia severity. Seven items are scored from 0-4 with zero being no dyskinesia observed and 4 being severe dyskinesia. Higher scores indicate a worse outcome.
Measured: baseline up to 15 weeks
Evaluate initial efficacy of repeated administration on peak dose dyskinesia
Determined by post-treatment change from baseline of Hauser motor symptom diary during the 1b portion.
Measured: baseline up to 15 weeks
Obtain additional efficacy information
Determined by change from baseline of Dyskinesia as measured by MDS-UPDRS (Unified Parkinson's Disease Rating Scale) Part IV. This scale has a minimum of 0 and a maximum of 24. Higher scores mean a worse outcome.
Measured: baseline up to 15 weeks
Obtain additional efficacy information
Determined by change from baseline of grip strength measured with hand dynamometer
Measured: baseline up to 15 weeks
Assess PK parameters during repeated dose administration
Determined by assessing bi-weekly the steady state serum concentration of IMM02-KORA during repeated administration during the 1b portion
Measured: baseline up to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyskinesia, Medication-inducedStudies 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
- Sequential
- Model description
- The first phase (Ia) will aim to establish safety and tolerability by an accelerated dose titration approach, and pharmacokinetic (PK) studies. The second phase (Ib) will aim to establish a safe dosing regimen by repeated administration based on prior determined PK parameters.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mani Nistor, Study director, Immunis, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905976
- Sponsor's protocol ID
- KORA-LID-1
- Acronym
- KORA-LID-1
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Single and Repeated Dose of IMM02-KORA in PD-associated Dyskinesia
- ClinicalTrials.gov ID
- NCT07905976
- Acronym / sponsor ID
- KORA-LID-1 / KORA-LID-1
- Keywords
- Immunis, Immunis, Inc., Dyskinesia, PARKINSON'S DISEASE-ASSOCIATED DYSKINESIA, KORA-LID, KORA-LID-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Immunis, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 30 Oct 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.
The goal of this clinical trial is to test Safety and tolerability of single and repeated dose of IMM02-KORA in subjects with PD-associated dyskinesia.
Detailed description
The proposed study will assess the safety of IMM02-KORA (nalfurafine hydrochloride) - a selective kappa opioid receptor agonist - and will comprise two phases. The first phase (Ia) will aim to establish safety and tolerability by an accelerated dose titration approach, concomitant with pharmacokinetic (PK) studies. The second phase (Ib) will aim to establish a safe dosing regimen for repeated administration based on the previously determined PK parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The first phase (Ia) will aim to establish safety and tolerability by an accelerated dose titration approach, and pharmacokinetic (PK) studies. The second phase (Ib) will aim to establish a safe dosing regimen by repeated administration based on prior determined PK parameters.
| Arm | Type | Receives |
|---|---|---|
| IMM02-KORA 1a and PK | Experimental | Drug: IMM02-KORAPhase Ia will be a single oral dose accelerated titration administered at assumed clearance intervals. The doses will escalate in 2.5µg increments (2.5, 5.0, 7.5, 10.0, 12.5µg) p.o., daily. Titration will continue until at least one participant responds positively, which will define the minimum inhibiting dose (MID) of dyskinesia symptoms. After a dose limiting toxicity (DLT), the accelerated titration will convert into a 3+3 design, enrolling 3 additional participants at the same dose. If additional DLTs occur, that dose will be considered the maximum tolerated dose (MTD). If MTD is reached and fewer than 2 of 6 participants respond positively, a MID will not have been defined and the trial will stop. The PK study will start one week after the last administered dose while participants are monitored for AEs. For the PK study, 3 participants without DLTs will be admitted to the hospital for 3 days, at least 7 days after their previous IMM02-KORA dose. |
| IMM02-KORA 1b | Experimental | Drug: IMM02-KORAThe phase Ib will start after completion of PK study. For this part, additional 10 patients will be enrolled to take a repeated dose of IMP medication with the appropriate size and frequency for 4 weeks total duration, followed by additional 4 weeks of observations in the absence of the IMP administration. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The subject presents with a diagnosis of idiopathic Parkinson's disease
- PD subjects taking stable doses of IR levodopa for at least 4 weeks before Screening Visit
- The dose of levodopa and all PD drugs used during the trial anticipated to remain unchanged throughout the duration of the trial.
- The patient must present symptomatic levodopa induced dyskinesias that is predictable (peak-dose dyskinesia) and is not troublesome, as assessed by the investigator
- The patient did not start taking anti-dyskinetic medication, however, is qualified to start anti-dyskinetic medication based on investigator's assessment
Key exclusion criteria (17 listed)
- Unmanaged/uncontrolled comorbidities, including current clinically significant gastro intestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease, acute gastric/duodenal ulcer, hypertension that is not well controlled, asthma, chronic obstructive pulmonary disease (COPD), and unstable Type I diabetes. Subjects with a history of gastric/duodenal ulcer who have not had a recent episode of acute gastritis and are not currently experiencing gastric pain will be eligible for inclusion.
- Neoplastic disorder, which is either currently active or has been in remission for less than one year.
- Patients with severe renal or hepatic impairment.
- Concomitant disease likely to interfere with trial medication (e.g. capable of altering absorption, metabolism, or elimination of the trial drug).
- The subject has any clinically significant illness that, in the Investigator's opinion, might interfere with the subject's ability to participate in the trial.
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 |
|---|---|---|
| IMM02-KORAAlso: TRK-820, MT-9938, AC-820, KORAIMM02-KORA (nalfurafine hydrochloride) is a synthetic selective kappa opioid receptor agonist (KORA). | Drug | IMM02-KORA 1a and PK, IMM02-KORA 1b |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs) and DLT
Time frame: baseline up to 15 weeks
Safety and tolerability of single increasing IMM02-KORA doses
14 secondary outcomes
Obtain information on a minimum inhibitory dose (MID) on peak dose dyskinesia and evaluate initial efficacy of repeated administration on peak dose dyskinesia
Time frame: baseline up to 15 weeks
Obtain information on a minimum inhibitory dose (MID) on peak dose dyskinesia and evaluate initial efficacy of repeated administration on peak dose dyskinesia
Time frame: baseline up to 15 weeks
Obtain PK parameters necessary to calculate a repeated dose regimen
Time frame: baseline up to 15 weeks
Obtain PK parameters necessary to calculate a repeated dose regimen
Time frame: baseline up to 15 weeks
Obtain PK parameters necessary to calculate a repeated dose regimen
Time frame: baseline up to 15 weeks
Obtain PK parameters necessary to calculate a repeated dose regimen
Time frame: baseline up to 15 weeks
Obtain PK parameters necessary to calculate a repeated dose regimen
Time frame: baseline up to 15 weeks
Obtain information on treatment interference with neurotransmitters
Time frame: baseline up to 15 weeks
Obtain information on treatment interference with neurotransmitters
Time frame: baseline up to 15 weeks
Evaluate initial efficacy of repeated administration on peak dose dyskinesia
Time frame: baseline up to 15 weeks
Evaluate initial efficacy of repeated administration on peak dose dyskinesia
Time frame: baseline up to 15 weeks
Obtain additional efficacy information
Time frame: baseline up to 15 weeks
Obtain additional efficacy information
Time frame: baseline up to 15 weeks
Assess PK parameters during repeated dose administration
Time frame: baseline up to 15 weeks
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 30 Oct 2026.
Related trials for Dyskinesia, Medication-induced
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 4
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
Schizophrenia, Schizoaffective Disorder
Recruiting
rTMS as an Intervention for Levodopa-induced Dyskinesia
Dyskinesia, Drug-Induced, Parkinson Disease
Enrolling by invitation
Neural Mechanisms of Clinically Designed Improvisatory Music for Alzheimer's Disease
Alzheimer Disease
Not yet recruitingObservational study
A Computer-Assisted Tool for Objective Assessment of Extrapyramidal Symptoms
Extrapyramidal Symptoms, Drug-induced Parkinsonism
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.
Mani Nistor study director
Immunis, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMM02-KORA in people with Dyskinesia, Medication-induced and Dyskinesia, Drug-Induced, run by Immunis, Inc..
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 11 inclusion and 17 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 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Mani Nistor (9492662501, Mani@immunisbiomedical.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 treatment-emergent adverse events (TEAEs) and DLT (time frame: baseline up to 15 weeks). 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 30 Oct 2026.