A Study of SPY001-001 in Healthy Volunteers

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of SPY001-001 in Healthy Participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06448247

Enrollment

Registered

2024-06-07

Start date

2024-06-06

Completion date

2026-03-10

Last updated

2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose, first in human safety, tolerability, and pharmacokinetic study of SPY001-001 in healthy participants.

Interventions

DRUGSPY001-001

Experimental

OTHERPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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, 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

Design outcomes

Primary

Measure	Time frame	Description
Treatment emergent adverse events	Up to 64 weeks	Incidence, severity, and causal relationship of TEAEs

Secondary

Measure	Time frame	Description
Cmax	Up to 64 weeks	Maximum concentration after single and multiple ascending doses
Tmax	Up to 64 weeks	Time to reach maximum concentration after single and multiple ascending doses
t1/2	Up to 64 weeks	Half life after single and multiple doses
AUC	Up to 64 weeks	Area under the curve after single and multiple ascending doses
ADA	Up to 64 weeks	Incidence of anti-drug antibody after single and multiple ascending doses

Countries

Canada, United States

Contacts

STUDY_CHAIRDeanna Nguyen, MD

Spyre Therapeutics

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026