A Phase 1 Study of 99mTc-p5+14 in Healthy Volunteers and Patients With AL or ATTR Systemic Amyloidosis

Conditions

• Systemic Amyloidosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• 99mTc-p5+14 is an amyloid reactive peptide labeled with technetium-99m. — DRUG
  Peptide p5+14 is a pan-amyloid reactive, synthetic 45 L-amino acid polypeptide with a net +12 positive charge that can bind two major components of all extracellular amyloid deposits: (i) hypersulfated heparan sulfate glycosaminoglycans (proteoglycans) and (ii) amyloid fibrils. The polypeptide, labeled with iodine-124, has been shown (study AMY1001) to bind amyloid in all organs including the heart. This study will evaluate a Tc-99m-labeled version of the peptide for gamma imaging.
• 99mTc-Pyrophosphate — DRUG
  99mTc-PYP is an FDA-approved, commercially available bone-seeking radiotracer used routinely in nuclear medicine. 99mTC-PYP imaging is used clinically for the diagnosis of cardiac ATTR amyloidosis.

Study Details

This study will investigate 99mTc-p5+14, an amyloid-reactive synthetic peptide, p5+14, radiolabeled with technetium-99m, as a radiotracer for detecting paamyloid deposits in patients with AL or ATTR-associated systemic amyloidosis, notably with cardiac involvement.

Key Dates

First listed

Jul 19, 2023

Start date

Sep 18, 2023

Status verified

Jul 2026

Primary completion

Dec 31, 2026

Completion

Jun 30, 2027

Study Design

Enrollment

31 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Estimation of dosimetry for 99mTc-p5+14 and Biodistribution Of 99mtc-p5+14 In Healthy Subjects
  For dosimetry, healthy subjects (n=3) and patients with a confirmed diagnosis of AL (n=1) or ATTR amyloidosis (n=1) will be administered a single IV dose of up to 1 mg of 99mTc-p5+14 (\~20 mCi) by slow push (\~1 mL/5 sec.). Subjects will then undergo serial planar scintigraphic imaging at \~30 minutes, \~1 hour, \~2 hours, \~4 hours, \~6 hours, and \~24 hours post-injection. At the 4-hour time point, the subject will also undergo a single SPECT/CT scan to provide additional data for estimating dosimetry. Before injection of the radiotracer and at each imaging session, \~2 -3 mL of blood will be acquired to determine the whole blood radioactivity. An echo examination will also be performed. For physiological biodistribution, healthy volunteers (n=5) will undergo an echo examination, thereafter, they will be administered a single IV dose of 99mTc-p5+14 (20 mCi) and will undergo a planar image acquisition followed by SPECT/CT imaging at \~1 hour and \~3 hours post-injection.
• Experimental: Biodistribution in patients with systemic AL or ATTR amlyoidosis
  On Day 1, patients with a confirmed diagnosis of systemic AL or ATTR (with or without a positive PyP scan) will be administered a single IV dose of up to 1 mg of 99mTc-p5+14 (\~20 mCi) by slow push (\~1 mL/5 sec.). At \~1 hour and \~3 hours post-injection, patients will undergo whole body planar imaging followed by abdominothoracic SPECT/CT imaging. Vital signs (blood pressure, respiration rate, temperature, and pulse) will be acquired before injection of the 99mTc-p5+14, and at \~3 hours post injection. ECG measurements will be made within 1 hour prior to, and within 15 minutes after, injection. On Day 3, patient will undergo a trans thoracic echo examination. On Day 4, patients will undergo Technescan™ 99mTc-PYP (20 mCi) planar and SPECT/CT imaging at \~1 hour and \~3 hours post-injection. Vital signs (blood pressure, respiration rate, temperature, and pulse) will be acquired before injection of the 99mTc-PYP, and at \~3 hours post injection. ECG measurements will be made as on Day 1.

Primary Outcome Measure

Whole body effective dosimetry measurement [ Time Frame: From enrollment to the end of study is 8 days ]

Central Contacts

• Emily B Martin, PhD
  865-305-9533
  [email protected]

Locations (1)

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