A Phase 1 interventional study of IMM02-KORA in Dyskinesia, Medication-induced and Dyskinesia, Drug-Induced, sponsored by Immunis, Inc.. Not yet recruiting. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Immunis, Inc. · Phase 1, Interventional, and Treatment
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.
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.
179 studies on the registry are indexed under Dyskinesias; 24 are open to participants now.
This study's planned enrollment of 15 is below the median of 36 across 139 interventional studies indexed under Dyskinesias.
Browse Dyskinesias studies →Immunis, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: IMM02-KORA
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.
Drug: IMM02-KORA
IMM02-KORA (nalfurafine hydrochloride) is a synthetic selective kappa opioid receptor agonist (KORA).
Also known as: TRK-820, MT-9938, AC-820, KORA
Incidence and severity of treatment-emergent adverse events (TEAEs) and DLT
Safety and tolerability of single increasing IMM02-KORA doses
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
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.
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
Determined by change from baseline of Hauser motor symptom diary
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline up to 15 weeks
Obtain additional efficacy information
Determined by change from baseline of grip strength measured with hand dynamometer
Time frame: 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
Time frame: baseline up to 15 weeks
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: TRK 820
Immunis, Inc.