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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06622070
Registration number
NCT06622070
Ethics application status
Date submitted
30/09/2024
Date registered
1/10/2024
Date last updated
27/11/2024
Titles & IDs
Public title
A Study of SPY002-072 in Healthy Volunteers
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Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of SPY002-072 in Healthy Participants
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Secondary ID [1]
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SPY002-072-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SPY002-072
Other interventions - Placebo
Experimental: SAD Cohorts, Experimental Arm - Participants will receive a single dose of SPY002-072 in a dose escalation format
Placebo comparator: SAD Cohorts, Placebo Arm - Participants will receive a single dose of placebo
Treatment: Drugs: SPY002-072
Experimental
Other interventions: Placebo
Placebo
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Treatment emergent adverse events
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Assessment method [1]
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Incidence, severity, and causal relationship of TEAEs
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Timepoint [1]
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Up to 40 weeks
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Secondary outcome [1]
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Cmax
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Assessment method [1]
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Maximum concentration after single dose
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Timepoint [1]
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Up to 40 weeks
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Secondary outcome [2]
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t1/2
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Assessment method [2]
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Half life after single dose
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Timepoint [2]
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Up to 40 weeks
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Secondary outcome [3]
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Tmax
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Assessment method [3]
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Time to reach maximum concentration after single dose
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Timepoint [3]
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Up to 40 weeks
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Secondary outcome [4]
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ADA
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Assessment method [4]
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Incidence of anti-drug antibody after single dose
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Timepoint [4]
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Up to 40 weeks
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Secondary outcome [5]
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AUC
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Assessment method [5]
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Area under the curve after single dose
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Timepoint [5]
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Up to 40 weeks
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Eligibility
Key inclusion criteria
* Healthy men and women
* Willing and able to attend the necessary visits to the CRU, comply with all testing requirements, remain at the study site unit for the duration of the confinement period and return for the outpatient visits
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Participation in more than one cohort
* Evidence of clinically significant abnormality or disease
* Known history of illicit drug use or drug abuse, cannabis/cannabinoid use, harmful alcohol use (at the Investigator's discretion), alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study agent
* History of severe allergic reactions or hypersensitivity
* Donation or loss of = 1 unit of whole blood within 1 month prior to dosing
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/11/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
8/08/2026
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Actual
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Sample size
Target
56
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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Canada
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State/province [2]
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Quebec
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Spyre Therapeutics, Inc.
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Altasciences Company Inc.
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single-dose, first in human safety, tolerability, and pharmacokinetic study of SPY002-072 in healthy participants.
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Trial website
https://clinicaltrials.gov/study/NCT06622070
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Joshua Friedman, MD
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Address
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Spyre Therapeutics
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Medical Director, Clinical Development
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Address
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Country
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Phone
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617-651-5940
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Fax
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Email
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Spyre_SPY002-072-101@spyre.com
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06622070
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