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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06622070




Registration number
NCT06622070
Ethics application status
Date submitted
30/09/2024
Date registered
1/10/2024
Date last updated
1/10/2024

Titles & IDs
Public title
A Study of SPY002-072 in Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
SPY002-072-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SPY002-072
Other interventions - Placebo

Experimental: SAD Cohorts, Experimental Arm - Participants will receive a single dose of SPY002-072 in a dose escalation format

Placebo comparator: SAD Cohorts, Placebo Arm - Participants will receive a single dose of placebo


Treatment: Drugs: SPY002-072
Experimental

Other interventions: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment emergent adverse events
Timepoint [1] 0 0
Up to 40 weeks
Secondary outcome [1] 0 0
Cmax
Timepoint [1] 0 0
Up to 40 weeks
Secondary outcome [2] 0 0
t1/2
Timepoint [2] 0 0
Up to 40 weeks
Secondary outcome [3] 0 0
Tmax
Timepoint [3] 0 0
Up to 40 weeks
Secondary outcome [4] 0 0
ADA
Timepoint [4] 0 0
Up to 40 weeks
Secondary outcome [5] 0 0
AUC
Timepoint [5] 0 0
Up to 40 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
17/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/08/2026
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Spyre Site 1 - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Spyre Therapeutics, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06622070
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joshua Friedman, MD
Address 0 0
Spyre Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Medical Director, Clinical Development
Address 0 0
Country 0 0
Phone 0 0
617-651-5940
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06622070