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NCT05974579COMPLETEDanonymous

A Single Center, Open Label Study to Evaluate Biodistribution, Pharmacokinetics and Safety of [89Zr]Zr-DFO-AP-101 PET (Positron Emission Tomography) in Healthy Volunteers and Amyotrophic Lateral Sclerosis (ALS) Patients

Sponsor

Source record

Université de Sherbrooke

Phase

Source record

Phase 1

Modality

AI-normalized

small molecule

Target

AI-normalized

[89Zr]Zr-DFO-AP-101 is designed to target misfolded SOD1 protein associated with amyotrophic lateral sclerosis (ALS), facilitating visualization of CNS pathology through PET imaging.

Indication / condition

AI-normalized

Amyotrophic Lateral Sclerosis

Intervention

Source record

89Zr-DFO-AP-101

Source & freshness

Source record

NCT ID

NCT05974579

Original source

ClinicalTrials.gov

Source last updated

Jun 01, 2026

Ingested at

Jun 16, 2026

Internal sync

Jun 16, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT05974579

Title

A Single Center, Open Label Study to Evaluate Biodistribution, Pharmacokinetics and Safety of [89Zr]Zr-DFO-AP-101 PET (Positron Emission Tomography) in Healthy Volunteers and Amyotrophic Lateral Sclerosis (ALS) Patients

Sponsor

Université de Sherbrooke

Status

COMPLETED

Phase

Phase 1

Condition raw

Amyotrophic Lateral Sclerosis

Condition normalized

Amyotrophic Lateral Sclerosis

Modality raw

small molecule

Modality normalized

small molecule

Target raw

[89Zr]Zr-DFO-AP-101 is designed to target misfolded SOD1 protein associated with amyotrophic lateral sclerosis (ALS), facilitating visualization of CNS pathology through PET imaging.

Target normalized

[89Zr]Zr-DFO-AP-101 is designed to target misfolded SOD1 protein associated with amyotrophic lateral sclerosis (ALS), facilitating visualization of CNS pathology through PET imaging.

Interventions

89Zr-DFO-AP-101

Public preview

Source record

The study, sponsored by Université de Sherbrooke in collaboration with Eli Lilly and Chorus Wellness Inc., aims to establish the safety and biodistribution of the radiotracer [89Zr]Zr-DFO-AP-101 in both healthy volunteers and ALS patients. Given the lack of diagnostic tools for ALS, this asset has significant commercial potential as a first-in-class imaging biomarker that could enhance early detection and monitoring of disease progression. The ALS market is relatively underserved, with current diagnostic methods leading to misdiagnosis and delayed treatment. Successful outcomes from this trial could position [89Zr]Zr-DFO-AP-101 as a critical tool in neurology, potentially leading to partnerships or licensing opportunities with larger pharmaceutical companies focused on neurodegenerative diseases.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

A Single Center, Open Label Study to Evaluate Biodistribution, Pharmacokinetics and Safety of [89Zr]Zr-DFO-AP-101 PET (Positron Emission Tomography) in Healthy Volunteers and Amyotrophic Lateral Sclerosis (ALS) Patients

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 17, 2026

NCT ID

NCT05974579

Status

COMPLETED

Phase

Phase 1

Sponsor

Université de Sherbrooke

Executive brief

Investment-Ready Snapshot

The study, sponsored by Université de Sherbrooke in collaboration with Eli Lilly and Chorus Wellness Inc., aims to establish the safety and biodistribution of the radiotracer [89Zr]Zr-DFO-AP-101 in both healthy volunteers and ALS patients. Given the lack of diagnostic tools for ALS, this asset has significant commercial potential as a first-in-class imaging biomarker that could enhance early detection and monitoring of disease progression. The ALS market is relatively underserved, with current diagnostic methods leading to misdiagnosis and delayed treatment. Successful outcomes from this trial could position [89Zr]Zr-DFO-AP-101 as a critical tool in neurology, potentially leading to partnerships or licensing opportunities with larger pharmaceutical companies focused on neurodegenerative diseases.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedJun 01, 2026
Internal syncJun 16, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT05974579

Indication

Amyotrophic Lateral Sclerosis

Modality

small molecule

Target

[89Zr]Zr-DFO-AP-101 is designed to target misfolded SOD1 protein associated with amyotrophic lateral sclerosis (ALS), facilitating visualization of CNS pathology through PET imaging.

Intervention

89Zr-DFO-AP-101

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.