Health TrialsbyHealthPanel

A Study of SPY002-072 in Healthy Volunteers

ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSpyre Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • SPY002-072

    Drug

    Experimental

  • Placebo

    Other intervention

    Placebo

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: SAD Cohorts, Experimental ArmExperimental treatment 1 intervention
Group B: SAD Cohorts, Placebo ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Treatment emergent adverse events

Incidence, severity, and causal relationship of TEAEs

Time frame
Up to 40 weeks

Secondary outcomes

1

Cmax

Maximum concentration after single dose

Time frame
Up to 40 weeks
2

t1/2

Half life after single dose

Time frame
Up to 40 weeks
3

Tmax

Time to reach maximum concentration after single dose

Time frame
Up to 40 weeks
4

ADA

Incidence of anti-drug antibody after single dose

Time frame
Up to 40 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Spyre Therapeutics, Inc.

Lead sponsor

Altasciences Company Inc.

Collaborator

Source ClinicalTrials.gov
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