HealthyPhase 1NCT06448247
A Study of SPY001-001 in Healthy Volunteers
A Phase 1 study testing SPY001-001 in people with Healthy, run by Spyre Therapeutics, Inc. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SPY001-001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Jun 2024to 10 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official 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
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.
- Conditions
- Healthy
- Being tested
- SPY001-001, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPY001-001Drug
Experimental
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohorts 1-5 Experimental Arm | Experimental | Participants will receive a single dose of SPY001-001 in a dose escalation format Receives: Drug: SPY001-001 |
| SAD Cohorts 1-5 Placebo Arm | Placebo comparator | Participants will receive a single dose of placebo Receives: Other: Placebo |
| MAD Cohorts 1-2 Experimental Arm | Experimental | Participants will receive two doses of SPY001-001 in a dose escalation format Receives: Drug: SPY001-001 |
| MAD Cohorts 1-2 Placebo Arm | Placebo comparator | Participants will receive two doses of placebo Receives: Other: Placebo |
| SAD Cohorts 6-7 Experimental Arm | Experimental | Participants of Japanese descent will receive a single dose of SPY001-001 Receives: Drug: SPY001-001 |
| SAD Cohorts 6-7 Placebo Arm | Placebo comparator | Participants of Japanese descent will receive a single dose of placebo Receives: Other: Placebo |
| SAD Cohorts 8-9 Experimental Arm | Experimental | Participants of Chinese descent will receive a single dose of SPY001-001 Receives: Drug: SPY001-001 |
| SAD Cohorts 8-9 Placebo Arm | Placebo comparator | Participants of Chinese descent will receive a single dose of placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent adverse events
Incidence, severity, and causal relationship of TEAEs
Measured: Up to 64 weeks
Secondary outcomes (5)
Cmax
Maximum concentration after single and multiple ascending doses
Measured: Up to 64 weeks
Tmax
Time to reach maximum concentration after single and multiple ascending doses
Measured: Up to 64 weeks
t1/2
Half life after single and multiple doses
Measured: Up to 64 weeks
AUC
Area under the curve after single and multiple ascending doses
Measured: Up to 64 weeks
ADA
Incidence of anti-drug antibody after single and multiple ascending doses
Measured: Up to 64 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start6 Jun 2024
- Primary completion10 Mar 2026
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spyre Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Altasciences Company Inc.
- Responsible party
- Sponsor
- Investigators
- Deanna Nguyen, MD, Study chair, Spyre Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448247
- Sponsor's protocol ID
- SPY001-101
- Status last verified
- Mar 2026
- First submitted
- 3 Jun 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06448247
- Acronym / sponsor ID
- SPY001-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Spyre Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Altasciences Company Inc.
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| SAD Cohorts 1-5 Experimental Arm | Experimental | Drug: SPY001-001Participants will receive a single dose of SPY001-001 in a dose escalation format |
| SAD Cohorts 1-5 Placebo Arm | Placebo comparator | Other: PlaceboParticipants will receive a single dose of placebo |
| MAD Cohorts 1-2 Experimental Arm | Experimental | Drug: SPY001-001Participants will receive two doses of SPY001-001 in a dose escalation format |
| MAD Cohorts 1-2 Placebo Arm | Placebo comparator | Other: PlaceboParticipants will receive two doses of placebo |
| SAD Cohorts 6-7 Experimental Arm | Experimental | Drug: SPY001-001Participants of Japanese descent will receive a single dose of SPY001-001 |
| SAD Cohorts 6-7 Placebo Arm | Placebo comparator | Other: PlaceboParticipants of Japanese descent will receive a single dose of placebo |
| SAD Cohorts 8-9 Experimental Arm | Experimental | Drug: SPY001-001Participants of Chinese descent will receive a single dose of SPY001-001 |
| SAD Cohorts 8-9 Placebo Arm | Placebo comparator | Other: PlaceboParticipants of Chinese descent will receive a single dose of placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPY001-001Experimental | Drug | MAD Cohorts 1-2 Experimental Arm, SAD Cohorts 1-5 Experimental Arm, SAD Cohorts 6-7 Experimental Arm, SAD Cohorts 8-9 Experimental Arm |
| PlaceboPlacebo | Other | MAD Cohorts 1-2 Placebo Arm, SAD Cohorts 1-5 Placebo Arm, SAD Cohorts 6-7 Placebo Arm, SAD Cohorts 8-9 Placebo Arm |
Primary outcome
Treatment emergent adverse events
Time frame: Up to 64 weeks
Incidence, severity, and causal relationship of TEAEs
5 secondary outcomes
Cmax
Time frame: Up to 64 weeks
Tmax
Time frame: Up to 64 weeks
t1/2
Time frame: Up to 64 weeks
AUC
Time frame: Up to 64 weeks
ADA
Time frame: Up to 64 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deanna Nguyen, MD study chair
Spyre Therapeutics
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPY001-001 in people with Healthy, run by Spyre Therapeutics, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment emergent adverse events (time frame: Up to 64 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.