SPY001-001 for Healthy Subjects

Not currently recruiting at 2 trial locations

Overseen By Medical Director, Clinical Development

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Spyre Therapeutics, Inc.

Disqualifiers: Drug abuse, Alcoholism, Smoking, others

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 64 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment, SPY001-001, to assess its safety and how the body processes it. Participants will receive either the treatment or a placebo (a harmless pill with no effects) in varying doses. Healthy individuals who can commit to all study visits and stay at the study site when needed may be suitable for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how it works in people.

Do I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the trial is for healthy participants, it's likely that you should not be on any regular medications. Please check with the trial coordinators for specific guidance.

Do I have to stop taking my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. However, since the trial is for healthy participants, it's likely that you should not be on any regular medications.

Is there any evidence suggesting that SPY001-001 is likely to be safe for humans?

Research has shown that SPY001-001 has been well-tolerated in studies so far. Early results from previous trials indicated that participants did not experience serious side effects. The treatment appears safe, as it did not cause significant harm to those who took it. Additionally, the medicine remains active in the body for an extended period, potentially reducing the number of doses needed. Overall, current evidence suggests that SPY001-001 is safe for further testing in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

SPY001-001 is unique because it offers a potential new approach by using a dose escalation format to optimize its safety and effectiveness. Unlike current treatments, which might rely on standard dosing, this method allows researchers to fine-tune dosage for better results. Additionally, SPY001-001's potential to be effective with fewer doses could lead to more convenient treatment regimens. Researchers are excited about its ability to target specific populations, such as those of Japanese and Chinese descent, which is a step toward more personalized medicine.

What evidence suggests that this trial's treatments could be effective?

Research has shown that SPY001-001, which participants in this trial may receive, could be a promising treatment, particularly for inflammatory bowel disease. Early results suggest it might work better or faster than current treatments. SPY001-001 is a monoclonal antibody that targets a molecule involved in gut inflammation. This treatment remains active in the body for over 90 days, potentially reducing the number of doses needed. Early trials have shown it to be well tolerated, a positive sign for its continued development. ^{3 6 7 8 9}

Who Is on the Research Team?

Deanna Nguyen, MD

Principal Investigator

Spyre Therapeutics

Are You a Good Fit for This Trial?

This trial is for healthy individuals who want to participate in a study testing the safety and effects of a new medication, SPY001-001. Specific eligibility details are not provided, but typically participants must meet certain health standards and cannot have conditions that would exclude them from safely participating.

Inclusion Criteria

I am healthy and cannot become pregnant or get someone pregnant.

I can attend all required visits and stay for the needed duration.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single and multiple ascending doses of SPY001-001 or placebo

Up to 64 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• SPY001-001

Trial Overview The study is evaluating SPY001-001, which is being compared to a placebo (a substance with no active drug). It's designed to assess how safe the drug is, how well it's tolerated by the body, and what happens to it inside the body over time after single or multiple doses.

How Is the Trial Designed?

Group I: SAD Cohorts 8-9 Experimental Arm Experimental Treatment 1 Intervention

Participants of Chinese descent will receive a single dose of SPY001-001

Group II: SAD Cohorts 6-7 Experimental Arm Experimental Treatment 1 Intervention

Participants of Japanese descent will receive a single dose of SPY001-001

Group III: SAD Cohorts 1-5 Experimental Arm Experimental Treatment 1 Intervention

Participants will receive a single dose of SPY001-001 in a dose escalation format

Group IV: MAD Cohorts 1-3 Experimental Arm Experimental Treatment 1 Intervention

Participants will receive two doses of SPY001-001 in a dose escalation format

Group V: MAD Cohorts 1-3 Placebo Arm Placebo Group 1 Intervention

Participants will receive two doses of placebo

Group VI: SAD Cohorts 1-5 Placebo Arm Placebo Group 1 Intervention

Participants will receive a single dose of placebo

Group VII: SAD Cohorts 6-7 Placebo Arm Placebo Group 1 Intervention

Participants of Japanese descent will receive a single dose of placebo

Group VIII: SAD Cohorts 8-9 Placebo Arm Placebo Group 1 Intervention

Participants of Chinese descent will receive a single dose of placebo

Who Is Running the Clinical Trial?

Spyre Therapeutics, Inc.

Lead Sponsor

Trials

4

Recruited

270+

Altasciences Company Inc.

Industry Sponsor

Trials

18

Recruited

860+

Published Research Related to This Trial

In a five-year analysis of 1,559 healthy volunteers across 142 phase I studies, the overall incidence of adverse events (AEs) was 8.8%, with most AEs being mild or moderate in severity, indicating that while AEs are common, they are generally not severe.

The incidence of AEs was significantly higher in multiple-dose studies compared to single-dose trials, highlighting the importance of study design in assessing the safety profile of active drugs, with a notable increase in AEs on the first day of drug administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in volunteers participating in phase I clinical trials: a single-center five-year survey in 1,559 subjects. Lutfullin, A., Kuhlmann, J., Wensing, G.[2019]

This systematic review analyzed 29 studies involving 935 participants and identified 822 volatile organic compounds (VOCs) from human skin, highlighting a distinct VOC signature associated with healthy skin.

The findings suggest that while many VOCs have potential exogenous origins, a significant portion may reflect endogenous metabolic processes, indicating the clinical potential of skin VOCs in diagnosing health and disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Human Skin Volatolome: A Systematic Review of Untargeted Mass Spectrometry Analysis. Mitra, A., Choi, S., Boshier, PR., et al.[2023]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

In a study of 182 patients aged 20-69 with femoral neck fractures treated with internal fixation, 73% of those with displaced fractures and 85% with non-displaced fractures reported good or excellent functional outcomes at 24 months.

Despite a significant percentage achieving good functional outcomes, patients did not fully regain their pre-fracture health-related quality of life, indicating that while surgical intervention is effective, it may not restore overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Good functional outcome but not regained health related quality of life in the majority of 20-69 years old patients with femoral neck fracture treated with internal fixation: A prospective 2-year follow-up study of 182 patients. Campenfeldt, P., Hedström, M., Ekström, W., et al.[2018]

The study validated the Brigham Spinal Stenosis (BSS) Questionnaire for measuring overall patient success after lumbar spinal surgery, using data from 197 patients before and 24 months after surgery.

Threshold scores for successful outcomes were established for the Symptom Severity (0.46), Physical Function (0.42), and Patient Satisfaction (2.42) domains, with the most balanced definition of overall success requiring patients to meet at least two of these criteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methodological approaches to developing criteria for improvement in lumbar spinal stenosis surgery. Tuli, SK., Yerby, SA., Katz, JN.[2019]

A new olfactory testing method for mice allows researchers to assess innate odor perception and sensitivity quickly and easily, without needing to restrict food or water, making it more humane and efficient.

This simple protocol can be conducted in a familiar environment for the mice and analyzed using standard software, making it accessible for any lab interested in studying olfactory functions, which are important for understanding neurodegenerative diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simple and Computer-assisted Olfactory Testing for Mice. Brai, E., Alberi, L.[2018]

In a comprehensive review of 54 phase-I studies involving 1015 healthy volunteers over 10 years, the overall incidence of adverse events was found to be 12.8%, with a higher rate for active drugs (13.7%) compared to placebo (7.9%).

Most adverse events were minor, with only 3% classified as severe, and no deaths or life-threatening events reported, highlighting that while adverse events are common in phase-I trials, they are typically not serious.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. Sibille, M., Deigat, N., Janin, A., et al.[2019]

In a Phase I drug study involving 29 healthy young male volunteers, only 4 participants had all their laboratory test results within the normal range, highlighting the challenges of defining 'normal' in clinical research.

The study suggests that the criteria for accepting healthy volunteers in drug trials should be more realistic, considering the high number of tests and the likelihood of finding abnormal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commentary. The normal volunteer in clinical investigation: how rigid should selection criteria be? Joubert, P., Rivera-Calimlim, L., Lasagna, L.[2019]

Two patients showed significant clinical improvements in weight gain and overall health through a virtual treatment approach, indicating the potential effectiveness of this model.

The positive outcomes suggest that augmented treatment teams in virtual settings can enhance patient acceptability and clinical assessment scores, providing preliminary support for this innovative approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtually delivered family-based eating disorder treatment using an enhanced multidisciplinary care team: A case study. Hellner, M., Bohon, C., Kolander, S., et al.[2021]

A new predictive model developed for pediatric intensive care can effectively classify patient outcomes as functional, compromised, or dead based on admission data from 1,663 patients, using factors like the Pediatric Risk of Mortality score and baseline functional status.

The model demonstrated high accuracy in a validation sample of 1,153 patients, achieving correct classification rates of 83.2% for functional, 74.4% for compromised, and 81.3% for death outcomes, indicating its potential to enhance quality of care assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediction of three outcome states from pediatric intensive care. Ruttimann, UE., Pollack, MM., Fiser, DH.[2019]

In a pilot study involving 25 emergency medicine faculty providers, monthly feedback reports and coaching sessions did not lead to significant improvements in patient satisfaction scores after 12 months, indicating that this intervention may not be effective in enhancing patient perceptions of care.

Despite the lack of measurable impact on satisfaction scores, the study successfully demonstrated the feasibility and logistics of implementing such feedback mechanisms, providing valuable insights for future, larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Press Ganey Provider Feedback to Improve Patient Satisfaction: A Pilot Randomized Controlled Trial. Newgard, CD., Fu, R., Heilman, J., et al.[2018]

The Mass Specthoscope is a new, convenient tool designed for rapid sampling and detection of volatile organic compounds (VOCs) emitted from human skin, which can provide physiological information about individuals.

In tests with nine healthy participants, the device successfully detected various skin-related VOCs, including those released after consuming a fenugreek drink, suggesting its potential for noninvasive diagnostics and metabolomic studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mass Specthoscope: A Hand-held Extendable Probe for Localized Noninvasive Sampling of Skin Volatome for Online Analysis. Abu Bakar, NH., Chiu, HY., Urban, PL.[2023]

The olfactory function field exam is a new tool designed to assess both odor identification and detection in large population studies, which has been lacking in previous research.

This tool allows for rapid and accurate evaluation of olfactory function in field environments, enabling researchers to explore the connections between olfactory abilities and various health and social outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Field Survey Measures of Olfaction: The Olfactory Function Field Exam (OFFE). Kern, DW., Wroblewski, KE., Schumm, LP., et al.[2020]

In a study comparing 192 healthy volunteers in Phase I drug trials to a control group of 112 matched individuals, the Phase I participants reported significantly fewer common complaints like headaches, stomach pain, and anxiety, suggesting they may have a lower tendency to report non-drug-related adverse events.

Psychological factors, such as anxiety and depression, were found to correlate positively with the incidence of complaints, while higher self-efficacy was associated with fewer complaints, indicating that psychological characteristics can influence the reporting of adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse non-drug-related complaints by healthy volunteers in Phase I studies compared to the healthy general population. Almeida, L., Coelho, R., Albino-Teixeira, A., et al.[2019]

A new olfactometer was developed using mostly off-the-shelf parts, making it affordable and easy to build, which is beneficial for conducting olfactory experiments without requiring extensive technical expertise.

This olfactometer provides fast and stable stimulus-rise and onset times, and has been validated for use in behavioral and psychophysiological studies, including event-related EEG experiments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methods for building an inexpensive computer-controlled olfactometer for temporally-precise experiments. Lundström, JN., Gordon, AR., Alden, EC., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06448247

A Study of SPY001-001 in Healthy Volunteers It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

2. sec.gov sec.gov/Archives/edgar/data/1636282/000162828024046860/exhibit991-8xkdatarelease.htm

Spyre Therapeutics Announces Positive Interim Results ... Interim data from a Phase 1 trial demonstrated that SPY001 was well tolerated and exhibited a human half-life of >90 days, a ~4-fold increase ...

3. synapse.patsnap.com synapse.patsnap.com/article/spyre-therapeutics-reports-positive-interim-phase-1-results-for-spy001-in-treating-inflammatory-bowel-disease

Spyre Therapeutics Reports Positive Interim Phase 1 ... The data indicate that SPY001 could improve or accelerate efficacy compared to current anti-α4β7 therapies. The findings support potential ...

4. ir.spyre.com ir.spyre.com/news-releases/news-release-details/spyre-therapeutics-reports-third-quarter-2025-financial-results

Spyre Therapeutics Reports Third Quarter 2025 Financial ... SPY001 – a highly potent and selective investigational monoclonal antibody targeting α4β7, engineered with half-life extension technology and formulated at high ...

5. prnewswire.com prnewswire.com/news-releases/spyre-therapeutics-announces-poster-presentations-at-digestive-disease-week-ddw-2025-including-up-to-eight-months-of-follow-up-from-an-ongoing-phase-1-trial-of-spy001-302445258.html

Spyre Therapeutics Announces Poster Presentations at ... Interim data from a Phase 1 trial demonstrated that SPY001 was well tolerated and exhibited a human half-life of ~80 days, approximately three- ...

6. clinicaltrials.gov clinicaltrials.gov/study/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 ...

7. ir.spyre.com ir.spyre.com/news-releases/news-release-details/spyre-therapeutics-announces-poster-presentations-digestive

Release Details "Extended follow-up data continue to show that SPY001 is well tolerated and has a PK and PD profile that supports potential best-in-class quarterly or biannual ...

8. prnewswire.com prnewswire.com/news-releases/spyre-therapeutics-announces-first-participants-dosed-in-phase-1-trial-of-spy001-its-novel-half-life-extended-anti-47-antibody-for-the-treatment-of-inflammatory-bowel-disease-302174975.html

Spyre Therapeutics Announces First Participants Dosed in ... A Phase 1 trial of SPY001 in healthy volunteers is ongoing, and the Company expects interim safety and pharmacokinetic data by year-end 2024.

9. delta.larvol.com delta.larvol.com/Products/?ProductId=22b8b5cb-e85b-4054-8bde-87b7fb4da214

SPY001 / Spyre Therap - "Reported positive interim pharmacokinetic ('PK') and safety data in Phase 1 trial of SPY001 in November 2024 and strengthened the balance sheet with a ...