iMagemHTT-009- FIH Evaluation of Novel Mutant Huntingtin PET Radioligand [11C]CHDI-00491009 (NCT06634628) | Clinical Trial Compass
RecruitingEarly Phase 1
iMagemHTT-009- FIH Evaluation of Novel Mutant Huntingtin PET Radioligand [11C]CHDI-00491009
Belgium27 participantsStarted 2026-02-24
Plain-language summary
This is a FIH (first-in-human) study to evaluate the clinical utility of the radioligand \[11C\]CHDI-00491009 as a PET tracer that binds specifically to mutant huntingtin (mHTT) aggregates in Huntington's disease (HD).
The study is divided into three cohorts defined by the Huntington's Disease Integrated Staging System (HD-ISS): Cohort 1 - initial tracer validation (3 healthy controls (HCs)); Cohort 2 - target validation and test-retest variability (6 HD-ISS Stage 3 participants and 6 age and biological sex-matched HCs); Cohort 3 - target sensitivity (6 HD-ISS Stage 2 participants and 6 age and biological sex-matched HCs). An interim analysis (IA) will be conducted after the completion of each cohort, followed by a final analysis for the study.
In addition to imaging, exploratory biomarkers, including somatic instability index, soluble mHTT and total huntingtin (HTT), will be assessed. All participants with HD (PwHD) will have an additional blood sample drawn at the screening visit to assess the somatic instability index and will also be invited to provide an optional cerebrospinal fluid (CSF) sample for measurement of soluble mHTT and total HTT.
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion criteria
✓. Are female or male adults, age 18-64 years old, inclusive.
✓. Have body mass index (BMI) between 19 and 35, inclusive.
✓. Have capacity to give full informed consent in writing and have read and signed the informed consent form (ICF).
✓. Are able to comply with study procedures, including fasting and blood sampling.
✓. Are able and willing to travel to the imaging center in Leuven, Belgium.
✓. Are willing to comply with the use of adequate contraceptive measures.
✓. Have a huntingtin gene CAG expansion between 40 and 50, inclusive; and
✓. Are classified within HD-ISS Stage 2 per the HD-ISS criteria using HD-ISS Modified Stage calculator.
Exclusion criteria
✕. Are currently participating in, or are less than 30 days after completing participation in, other therapeutic or imaging studies.
What they're measuring
1
The VT (volume of distribution total) of the PET radioligand will be measured with PET imaging.
Timeframe: Time Frame: Single point measure - 90 minutes scan
. Have previously participated in a PET imaging study in the past 12 months that, cumulatively with the current study, will exceed annual regulatory limits for radiation exposure.
✕. Have any disease, condition, or concomitant medication that significantly compromises the function of the body systems and that, in the opinion of the Investigator, might interfere with the conduct of the study or its interpretation.
✕. Are pregnant and breastfeeding females.
✕. Have concomitant use of antiplatelet or anticoagulant therapy (inclusive of acetylsalicylic acid).
✕. Have a bleeding disorder.
✕. Have a needle phobia.
✕. Have any metal objects present in the body that are incompatible with MRI.