iMagemHTT-009- FIH Evaluation of Novel Mutant Huntingtin PET Radioligand [11C]CHDI-00491009

Sponsor
CHDI Foundation, Inc.
Study ID
NCT06634628
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • Radioligand [11C]CHDI-00491009 — RADIATION
    Intravenous injection of radioligand in the arm with PET imaging of the brain.

Study Details

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.

Key Dates

Start date
Feb 24, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
27 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Cohort 1
    Radioligand \[11C\]CHDI-00491009 3 HCs - MRI and PET Radioligand is administered 1x each person
  • Experimental: Cohort 2
    Radioligand \[11C\]CHDI-00491009 6 HCs - MRI and PET 6 PwHD HD-ISS Stage 2 - MRI and PET Radioligand administered 2x (TRT) for 3 HCs and 3 PwHD Radioligand administered 1x for 3 HCs and 3 PwHD In addition, optional CSF collection for all PwHD
  • Experimental: Cohort 3
    Radioligand \[11C\]CHDI-00491009 6 HCs - MRI and PET 6 PwHD HD-ISS Stage 3 - MRI and PET Radioligand administered 1x for 6 HCs and 6 PwHD In addition, optional CSF collection for all PwHD Depending on previous results and as decided by executive committee, TRT may be included in Cohort 3. A TRT decision would include one extra imaging session per participant (i.e., radioligand administered 2x per participant.)

Primary Outcome Measure

The VT (volume of distribution total) of the PET radioligand will be measured with PET imaging. [ Time Frame: Time Frame: Single point measure - 90 minutes scan ]

Central Contacts

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