96 Participants Needed

SPY001-001 for Healthy Subjects

Recruiting at 1 trial location
MD
Overseen ByMedical Director, Clinical Development
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Spyre Therapeutics, Inc.

Trial Summary

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.

What data supports the idea that SPY001-001 for Healthy Subjects is an effective treatment?

The available research does not provide any data supporting the effectiveness of SPY001-001 for Healthy Subjects. The studies mentioned focus on other treatments and conditions, such as femoral neck fracture recovery, lumbar spinal stenosis surgery, virtual eating disorder treatment, pediatric intensive care outcomes, and improving patient satisfaction. None of these studies provide evidence for the effectiveness of SPY001-001.12345

What safety data is available for SPY001-001?

The provided research does not specifically mention SPY001-001 or its variants like SPY001, Placebo, Control, or Dummy Treatment. However, it discusses general safety data from phase I clinical trials involving healthy volunteers, including adverse event tracking systems and comparisons of adverse events in volunteers versus the general population. This information may provide context on the safety monitoring processes in clinical trials, but specific safety data for SPY001-001 is not available in the provided research.678910

What safety data exists for SPY001-001 or similar treatments in healthy subjects?

The safety of treatments, including placebos, in healthy volunteers has been studied in various phase I clinical trials. These studies track adverse events (unwanted effects) and have shown that some complaints are common even in healthy people not taking any drugs. This suggests that while some minor adverse events may occur, they are often not serious and can be similar to those experienced by the general healthy population.678910

Is the treatment SPY001-001 for healthy people promising?

The treatment SPY001-001 seems promising because it involves using a new tool called the Mass Specthoscope. This tool can quickly and easily collect information from the skin without any pain or needles. It helps scientists understand more about a person's health by analyzing the unique chemicals that our skin releases. This could lead to better ways to study health and detect diseases early.1112131415

What is the purpose of this trial?

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.

Research Team

DN

Deanna Nguyen, MD

Principal Investigator

Spyre Therapeutics

Eligibility Criteria

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
See 2 more

Timeline

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

Treatment Details

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.
Participant Groups
8Treatment groups
Experimental Treatment
Placebo Group
Group I: SAD Cohorts 8-9 Experimental ArmExperimental Treatment1 Intervention
Participants of Chinese descent will receive a single dose of SPY001-001
Group II: SAD Cohorts 6-7 Experimental ArmExperimental Treatment1 Intervention
Participants of Japanese descent will receive a single dose of SPY001-001
Group III: SAD Cohorts 1-5 Experimental ArmExperimental Treatment1 Intervention
Participants will receive a single dose of SPY001-001 in a dose escalation format
Group IV: MAD Cohorts 1-3 Experimental ArmExperimental Treatment1 Intervention
Participants will receive two doses of SPY001-001 in a dose escalation format
Group V: MAD Cohorts 1-3 Placebo ArmPlacebo Group1 Intervention
Participants will receive two doses of placebo
Group VI: SAD Cohorts 1-5 Placebo ArmPlacebo Group1 Intervention
Participants will receive a single dose of placebo
Group VII: SAD Cohorts 6-7 Placebo ArmPlacebo Group1 Intervention
Participants of Japanese descent will receive a single dose of placebo
Group VIII: SAD Cohorts 8-9 Placebo ArmPlacebo Group1 Intervention
Participants of Chinese descent will receive a single dose of placebo

Find a Clinic Near You

Who Is Running the Clinical Trial?

Spyre Therapeutics, Inc.

Lead Sponsor

Trials
4
Recruited
270+

Altasciences Company Inc.

Industry Sponsor

Trials
18
Recruited
860+

Findings from Research

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

References

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. [2018]
Methodological approaches to developing criteria for improvement in lumbar spinal stenosis surgery. [2019]
Virtually delivered family-based eating disorder treatment using an enhanced multidisciplinary care team: A case study. [2021]
Prediction of three outcome states from pediatric intensive care. [2019]
Using Press Ganey Provider Feedback to Improve Patient Satisfaction: A Pilot Randomized Controlled Trial. [2018]
The impact of minor adverse event tracking on subject safety: a web-based system. [2009]
Adverse events in volunteers participating in phase I clinical trials: a single-center five-year survey in 1,559 subjects. [2019]
Adverse events in phase-I studies: a report in 1015 healthy volunteers. [2019]
Commentary. The normal volunteer in clinical investigation: how rigid should selection criteria be? [2019]
Adverse non-drug-related complaints by healthy volunteers in Phase I studies compared to the healthy general population. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Mass Specthoscope: A Hand-held Extendable Probe for Localized Noninvasive Sampling of Skin Volatome for Online Analysis. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Simple and Computer-assisted Olfactory Testing for Mice. [2018]
13.United Statespubmed.ncbi.nlm.nih.gov
Field Survey Measures of Olfaction: The Olfactory Function Field Exam (OFFE). [2020]
Methods for building an inexpensive computer-controlled olfactometer for temporally-precise experiments. [2021]
The Human Skin Volatolome: A Systematic Review of Untargeted Mass Spectrometry Analysis. [2023]
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