Actively Recruiting
First in Human Adaptive Study to Investigate the Kinetic Properties of the Novel PET Radioligand [11C]CHDI-00491009 and Its Suitability for Quantification of Aggregated Mutant Huntingtin in People With Huntington's Disease
Led by CHDI Foundation, Inc. · Updated on 2026-03-13
27
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
CHDI Foundation, Inc.
Lead Sponsor
U
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new PET radioligand called [11C]CHDI-00491009 to see if it can specifically bind to mutant huntingtin (mHTT) aggregates in the brains of people with Huntington's disease (HD). This first-in-human study uses an adaptive design with three groups based on Huntington's Disease Integrated Staging System (HD-ISS) stages, including healthy controls and participants with different HD stages. The study also explores biomarkers like somatic instability index and soluble mHTT to better understand the disease. The study involves three cohorts: Cohort 1 includes 3 healthy controls receiving one PET imaging session to validate tracer kinetics without mHTT target. Cohort 2 includes 6 HD-ISS Stage 3 participants and 6 matched healthy controls with PET imaging and MRI; some participants have repeat scans to assess variability. Cohort 3 includes 6 HD-ISS Stage 2 participants and 6 matched controls with similar imaging and optional cerebrospinal fluid sampling. Each cohort's results guide progression to the next, allowing detailed evaluation of the radioligand's suitability. Participants undergo PET imaging with a microdose injection of the radioligand lasting about 90 minutes per scan, along with MRI scans. Blood samples are collected at screening to assess biomarkers, and participants with HD may provide optional cerebrospinal fluid samples. The main measure is the radioligand's volume of distribution in the brain. Safety lab tests and clinical evaluations are done to monitor participant health throughout the study, which is designed to determine if the radioligand can be used as a biomarker for disease progression.
CONDITIONS
Brief Title
iMagemHTT-009- FIH Evaluation of Novel Mutant Huntingtin PET Radioligand [11C]CHDI-00491009
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 64 years, inclusive
- Body mass index (BMI) between 19 and 35, inclusive
- Ability to provide informed consent in writing
- Ability to comply with study procedures, including fasting and blood sampling
- Willingness to travel to the imaging center in Leuven, Belgium
- Willingness to use adequate contraceptive measures
- HD-ISS Stage 2 participants with huntingtin gene CAG expansion between 40 and 50
- Classified as HD-ISS Stage 2 using the HD-ISS Modified Stage calculator
- PIN score between 0.47 and 1.84 for HD-ISS Stage 2 participants
- Healthy controls with no known family history of Huntington's disease or tested negative for huntingtin gene CAG expansion
- Age and biological sex matched to HD participants in Cohorts 2 and 3 (except Cohort 1)
You will not qualify if you...
- Participation in other therapeutic or imaging studies within 30 days before this study
- Prior PET imaging study within 12 months exceeding radiation limits
- Any disease, condition, or medication interfering with study conduct or interpretation
- Pregnant or breastfeeding females
- Use of antiplatelet or anticoagulant therapy
- Bleeding disorders
- Needle phobia
- Presence of metal objects incompatible with MRI
- Metal objects in head or neck compatible with MRI
- Clinically significant abnormal safety lab results including positive HBsAg, HepC, HIV-1 or HIV-2
- For HD participants, unstable or inappropriate medication use for Huntington's disease within 30 days
- For healthy controls, family history of Huntington's disease without genetic testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to several weeks depending on cohort assignment
Participants undergo MRI and PET imaging with an intravenous injection of the radioligand [11C]CHDI-00491009 to assess tracer kinetics and binding properties.
1 to 2 imaging visits depending on cohort and test-retest requirements
Trial Site Locations
Total: 1 location
1
Universitaire Ziekenhuizen Leuven/ UZ Leuven/ UZL
Leuven, Belgium, 3000
Actively Recruiting
Research Team
W
Wim Vandenberghe, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
3
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