Trial · NCT07905976
Safety and Tolerability of Single and Repeated Dose of IMM02-KORA in PD-associated Dyskinesia
NCT07905976, Phase 1, Not yet recruiting, Immunis, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Tolerability of Single and Repeated Dose of IMM02-KORA in PD-associated Dyskinesia. Trials, record NCT07905976. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07905976
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability of Single and Repeated Dose of IMM02-KORA in PD-associated Dyskinesia
- NCT number
- NCT07905976
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 15 participants, estimated
- Lead sponsor
- Immunis, Inc.
- Conditions
- Dyskinesia, Medication-induced, Dyskinesia, Drug-Induced
- Interventions
- IMM02-KORA
- First posted
- 2026-10-30
- Last updated
- 2026-10-30
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and severity of treatment-emergent adverse events (TEAEs) and DLT | baseline up to 15 weeks | Safety and tolerability of single increasing IMM02-KORA doses |
| Secondary | Obtain information on a minimum inhibitory dose (MID) on peak dose dyskinesia and evaluate initial efficacy of repeated administration on peak dose dyskinesia | baseline up to 15 weeks | 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. |
| Secondary | Obtain information on a minimum inhibitory dose (MID) on peak dose dyskinesia and evaluate initial efficacy of repeated administration on peak dose dyskinesia | baseline up to 15 weeks | Determined by change from baseline of Hauser motor symptom diary |
| Secondary | Obtain PK parameters necessary to calculate a repeated dose regimen | baseline up to 15 weeks | Determined by obtaining information on Cmax of IMM02-KORA in serum. |
| Secondary | Obtain PK parameters necessary to calculate a repeated dose regimen | baseline up to 15 weeks | Determined by obtaining information on Tmax of IMM02-KORA in serum. |
| Secondary | Obtain PK parameters necessary to calculate a repeated dose regimen | baseline up to 15 weeks | Determined by obtaining information on T1/2 of IMM02-KORA in serum. |
| Secondary | Obtain PK parameters necessary to calculate a repeated dose regimen | baseline up to 15 weeks | Determined by obtaining information on area under the plasma concentration versus time curve (AUC) of IMM02-KORA in serum. |
| Secondary | Obtain PK parameters necessary to calculate a repeated dose regimen | baseline up to 15 weeks | Determined by calculating a dose size and interval of administration that maintain a MID serum concentration |
| Secondary | Obtain information on treatment interference with neurotransmitters | baseline up to 15 weeks | Determined by change from pre-administration of serum dopamine, norepinephrine, epinephrine, and serotonin |
| Secondary | Obtain information on treatment interference with neurotransmitters | baseline up to 15 weeks | Determined by change from baseline of pre-administration of testosterone, FSH and LH levels |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07905976
GET https://conductscience.org/api/trials/v1/NCT07905976/registered