A Study of SPY002-072 in Healthy Volunteers

NCT ID: NCT06622070

Last Updated: 2024-11-27

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-18

Study Completion Date

2026-08-08

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SAD Cohorts, Experimental Arm

Participants will receive a single dose of SPY002-072 in a dose escalation format

Group Type EXPERIMENTAL

SPY002-072

Intervention Type DRUG

Experimental

SAD Cohorts, Placebo Arm

Participants will receive a single dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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SPY002-072

Experimental

Intervention Type DRUG

Placebo

Placebo

Intervention Type OTHER

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Altasciences Company Inc.

INDUSTRY

Sponsor Role collaborator

Spyre Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joshua Friedman, MD

Role: STUDY_CHAIR

Spyre Therapeutics

Locations

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Spyre Site 2

Cypress, California, United States

Site Status NOT_YET_RECRUITING

Spyre Site 1

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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United States Canada

Central Contacts

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Medical Director, Clinical Development

Role: CONTACT

617-651-5940

Facility Contacts

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Sammy Armado

Role: primary

714-252-0700

Claudia Romero de los Reyes

Role: primary

450-973-3155 Ext. 113282

Other Identifiers

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SPY002-072-101

Identifier Type: -

Identifier Source: org_study_id