Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
96 participants
INTERVENTIONAL
2024-06-06
2026-05-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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SAD Cohorts 1-5 Experimental Arm
Participants will receive a single dose of SPY001-001 in a dose escalation format
SPY001-001
Experimental
SAD Cohorts 1-5 Placebo Arm
Participants will receive a single dose of placebo
Placebo
Placebo
MAD Cohorts 1-3 Experimental Arm
Participants will receive two doses of SPY001-001 in a dose escalation format
SPY001-001
Experimental
MAD Cohorts 1-3 Placebo Arm
Participants will receive two doses of placebo
Placebo
Placebo
SAD Cohorts 6-7 Experimental Arm
Participants of Japanese descent will receive a single dose of SPY001-001
SPY001-001
Experimental
SAD Cohorts 6-7 Placebo Arm
Participants of Japanese descent will receive a single dose of placebo
Placebo
Placebo
SAD Cohorts 8-9 Experimental Arm
Participants of Chinese descent will receive a single dose of SPY001-001
SPY001-001
Experimental
SAD Cohorts 8-9 Placebo Arm
Participants of Chinese descent will receive a single dose of placebo
Placebo
Placebo
Interventions
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SPY001-001
Experimental
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Evidence of clinically significant abnormality or disease
* Known history of illicit drug use or drug abuse, harmful alcohol use or alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study drug
* History of severe allergic reactions or hypersensitivity
* Donation or loss of \>1 unit of whole blood within 1 month prior to dosing
18 Years
65 Years
ALL
Yes
Sponsors
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Altasciences Company Inc.
INDUSTRY
Spyre Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Deanna Nguyen, MD
Role: STUDY_CHAIR
Spyre Therapeutics
Locations
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Spyre Site 2
Cypress, California, United States
Spyre Site 1
Montreal, Quebec, Canada
Countries
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Other Identifiers
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SPY001-101
Identifier Type: -
Identifier Source: org_study_id
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