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Recruiting NCT06622070

A Study of SPY002-072 in Healthy Volunteers

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SPY002-072, Placebo.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of SPY002-072 in Healthy Participants

Overview

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.

Interventions

  • Drug SPY002-072
    Experimental
  • Other Placebo
    Placebo

Primary outcome measures

  • Treatment emergent adverse events [Time frame: Up to 40 weeks]
Secondary outcome measures (5)
  • Cmax [Time frame: Up to 40 weeks]
  • t1/2 [Time frame: Up to 40 weeks]
  • Tmax [Time frame: Up to 40 weeks]
  • ADA [Time frame: Up to 40 weeks]
  • AUC [Time frame: Up to 40 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Spyre Site 2 — Cypress
Canada · 1 center
  • Spyre Site 1 — Montreal

Identifiers

NCT: NCT06622070 · SPY002-072-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗