iMagemHTT-009- FIH Evaluation of Novel Mutant Huntingtin PET Radioligand [11C]CHDI-00491009
Recruiting
Early Phase 1
Interventional Study
Huntington Disease
HD
PET Tracer
Positron Emission Tomography
Radioligand
Imaging
mHTT
Huntington's
Huntington's Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 64
- Sex
- Any
- Trial phase
- Early Phase 1
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 27 (estimated)
- Sponsor
- CHDI Foundation, Inc. · Other
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About This Trial
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)); Coh…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
PwHD HD-ISS Stages 2 and 3 and HC participants who:
1. Are female or male adults, age 18-64 years old, inclusive.
2. Have body mass index (BMI) between 19 and 35, inclusive.
3. Have capacity to give full informed consent in writing and have read and signed the informed consent …
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