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Proof of Mechanism Study to Evaluate Binding of Alfa-synuclein

NCT05274568 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-02-20

No results posted yet for this study

Summary

The overall goal of this protocol is to:

Evaluate \[18F\]UCB-2897 as an α-synuclein targeted radiopharmaceutical.

The primary objective is:

• Confirm a specific α -synuclein signal with \[18F\]UCB-2897 in participants with PD and/or MSA relative to healthy volunteers

Secondary and exploratory objectives are:

* Determine the safety and tolerability of microdose \[18F\]UCB-2897
* Evaluate preliminary dosimetry of \[18F\]UCB-2897

Additional exploratory objectives are:

* Determine the pharmacokinetics / metabolism of \[18F\]UCB-2897
* Determine the optimal imaging protocol for \[18F\]UCB-2897

Conditions

  • Parkinson Disease
  • Multisystem Atrophy
  • Healthy Volunteer

Interventions

DRUG

[18F]UCB-2897

Investigational Agent: \[18F\]UCB2897 is a clear solution formulated for intravenous (IV) injection. The product \[18F\]UCB2897is delivered in normal saline (0.9 % sodium chloride \[NaCl\]) formulated with the intent to contain approximately 3.3 % (v/v) ethanol (EtOH), polysorbate-80 (PS-80, 3.73 μL/mL) and sodium ascorbate (4.67 mg/mL). The final product bears a label with the following items: total activity (mCi), volume (mL), strength (mCi/mL), calibration date and time, batch number, and shelf life. \[18F\]UCB2897 will be stored at ambient temperature in its original container.

Sponsors & Collaborators

  • Invicro

    lead OTHER

Principal Investigators

  • David Russell, MD, Ph.D · Principal Investigator

  • Joyce Gibbons, PA-C · Sub-Investigator

  • Amy Knorr, MD · Sub-Investigator

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2023-10-25
Completion
2023-10-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05274568 on ClinicalTrials.gov