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OpenTrials
Completed

NCT Number: NCT06448247

A Study of SPY001-001 in Healthy Volunteers

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Spyre Site 1, Montreal, Quebec, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPY001-001

Drug

Experimental

Placebo

Other

Placebo

Primary outcomes

  1. Treatment emergent adverse events

    Time frame: Up to 64 weeks

    Incidence, severity, and causal relationship of TEAEs

Secondary outcomes

  1. Cmax

    Time frame: Up to 64 weeks

    Maximum concentration after single and multiple ascending doses

  2. Tmax

    Time frame: Up to 64 weeks

    Time to reach maximum concentration after single and multiple ascending doses

  3. t1/2

    Time frame: Up to 64 weeks

    Half life after single and multiple doses

  4. AUC

    Time frame: Up to 64 weeks

    Area under the curve after single and multiple ascending doses

  5. ADA

    Time frame: Up to 64 weeks

    Incidence of anti-drug antibody after single and multiple ascending doses

Sponsors and collaborators

Lead sponsor

Spyre Therapeutics, Inc.

Industry

Collaborators

  • Altasciences Company Inc.

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 7, 2024
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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