A Study of SPY002-072 in Healthy Volunteers | NCT06622070

Studies
A Study of SPY002-072 in Healthy Volunteers

NCT06622070

Sponsor

Spyre Therapeutics, Inc.

Status

Recruiting

Last Update Posted

Nov 27, 2024Actual

Enrollment

56Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

SPY002-072
Placebo

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 18, 2024Actual

Primary Completion Date

Apr 3, 2026Estimated

Completion Date

Aug 8, 2026Estimated

First Submitted Date

Sep 30, 2024

First Submission Date that Met QC Criteria

Sep 30, 2024

First Posted Date

Oct 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2024

Last Update Posted Date

Nov 27, 2024Actual

Name	Class
Altasciences Company Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SAD Cohorts, Experimental Arm	Experimental	Participants will receive a single dose of SPY002-072 in a dose escalation format	Drug: SPY002-072
SAD Cohorts, Placebo Arm	Placebo Comparator	Participants will receive a single dose of placebo	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SPY002-072	Drug	Experimental	SAD Cohorts, Experimental Arm
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment emergent adverse events	Incidence, severity, and causal relationship of TEAEs	Up to 40 weeks

Secondary Outcomes

Measure	Description	Time Frame
Cmax	Maximum concentration after single dose	Up to 40 weeks
t1/2	Half life after single dose	Up to 40 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Medical Director, Clinical Development	Contact	617-651-5940		Spyre_SPY002-072-101@spyre.com

Overall Officials

Name	Affiliation	Role
Joshua Friedman, MD	Spyre Therapeutics	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Spyre Site 2	Not yet recruiting	Cypress	California	90630	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided