99mTc-rhAnnexin V-128: a First In Man Study in Healthy Volunteers

NCT02182609 | Completed Phase 1

• 2 other identifiers: 1001CAAA113A12101
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are:

• To determine the safety and tolerability of a single dose of 99mTc-rhAnnexin V-128 administered as an intravenous bolus over 10-20 seconds.
• To determine the biodistribution, pharmacokinetics and radiation dosimetry of 99mTc-rhAnnexin V-128 in normal healthy adult volunteers.

Conditions

Healthy Adult Volunteers

Outcome Measures

Primary Outcomes (4)

• Adverse events

  Type and incidence of AEs, as well as severity and relatedness to the study medication will be tabulated. Special attention will be given to those subjects who prematurely discontinue the study or the study medication due to an AE, or who experience a severe AE or an SAE.

  Whole study period

• Laboratory assessments

  Laboratory data (Hematology, coagulation, biochemistry, and urinalysis) will be analysed with respect to the normal ranges of values provided by the local laboratory and with respect to pre-defined levels of change in these values. Abnormal laboratory test results will be tabulated.

  baseline and 24 hrs, 72 hrs and 30 days after injection

• Electrocardiography

  ECG parameters will include heart rate (HR), RR interval, PR interval, QRS width and QT interval. ECG results will be evaluated by means of descriptive statistics and frequency tabulations.

  screening and immediatly, 24hrs, 72 hrs, 7 days and 30 days after injection

• Vital signs

  Descriptive statistics of the vital signs (pulse rate and blood pressure) observed values as well as for the changes from baseline value will be created. Frequency tabulations with values within, below or above the normal ranges will be made.

  At each study visit

Secondary Outcomes (6)

• rhAnnexin V-128 serum concentration

  0, 5, 10, 15, 30, 60, 90, minutes and 3 h, 6h and 24 h post-injection

• Whole-body SPECT imaging

  30min, 90min, 3hrs, 6hrs and 24 hours post-injection

• Blood sample counting

  baseline and 0, 5,10, 15, 30, 60, 90 min, 3 h, 6 h and 24 hours post-injection

• Amount of 99mTc excreted in urine

  One sample at baseline and urine collection within 24 hours post-injection

• Amount of 99mTc excreted in faeces

  Baseline and within 24h post injection

Study Arms (1)

99mTc-rhAnnexin V-128

EXPERIMENTAL

Drug: Kit for the Preparation of 99mTc-rhAnnexin V-128

Interventions

Kit for the Preparation of 99mTc-rhAnnexin V-128 DRUG

Kit for the Preparation of Tc-99m Recombinant Human Annexin V-128 for Injection

99mTc-rhAnnexin V-128

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years
• No significant medical history
• Normal physical examination
• No clinically significant abnormalities in baseline laboratory values
• No clinically significant abnormalities on 12 lead electrocardiogram
• Female subjects must be post-menopausal, surgically sterilized or have negative urine beta human chorionic gonadotropin pregnancy test at initial screening and pre-injection on dosing day
• Written informed consent signed

You may not qualify if:

• Pregnancy or lactation
• Know hypersensitivity to the investigational drug or any of its components
• Current enrolment in another investigational study
• Unwillingness to provide or continue informed consent

Sponsors & Collaborators

• Advanced Accelerator Applications: lead
• Atreus Pharmaceuticals Corporation: collaborator

Study Sites (1)

The University of Ottawa Heart Institute

Ottawa, Ontario, ON K1Y 4W7, Canada

Location

MeSH Terms

Interventions

Receptor Protein-Tyrosine Kinases

Intervention Hierarchy (Ancestors)

Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Terrence D. Rudy, MD, FRCPC

  The University of Ottawa Heart Institute, The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 8, 2014
• Study Start: April 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: August 1, 2015
• Last Updated: November 21, 2019

Record last verified: 2019-11

Locations

CA (1)