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DISC-3405 for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by Disc Medicine, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 99 days
Awards & highlights

Study Summary

This trial will study the safety, how the body processes it, and how it affects the immune system in healthy adults.

Who is the study for?
This trial is for healthy adults, non-smokers, aged 18-65 with a BMI of 18.0 - 33.0 kg/m2 and weight ≥50kg (males) or ≥45kg (females). Participants should have no significant medical history or current infections, not use certain medications or supplements recently, and must not be pregnant or nursing.Check my eligibility
What is being tested?
The study tests DISC-3405's safety and effects in the body compared to a placebo in healthy volunteers. It looks at how the drug is tolerated, its journey through the body (pharmacokinetics), its action on the body (pharmacodynamics), and if it causes any immune response.See study design
What are the potential side effects?
Since this is an early-phase trial for DISC-3405 in humans, potential side effects are being investigated but may include typical drug reactions such as headaches, nausea, allergic reactions or other unforeseen issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 99 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 99 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Incidence of treatment-emergent clinically abnormal physical exam
Incidence of treatment-emergent clinically abnormal vital signs
+2 more
Secondary outcome measures
Area under the concentration-time curve from dosing to infinity (AUC0-∞)
Area under the concentration-time curve from dosing to the last measurable time point (AUC0-t)
Change from baseline in transferrin saturation (TSAT) levels
+9 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Single Ascending Dose of DISC-3405Experimental Treatment1 Intervention
Group II: Multiple Ascending Dose of DISC-3405Experimental Treatment1 Intervention
Group III: Multiple Ascending Dose of PlaceboPlacebo Group1 Intervention
Group IV: Single Ascending Dose of PlaceboPlacebo Group1 Intervention

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Disc Medicine, IncLead Sponsor
5 Previous Clinical Trials
405 Total Patients Enrolled
Will Savage, MD PhDStudy DirectorDisc Medicine
4 Previous Clinical Trials
363 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are septuagenarians eligible for the experimental procedure?

"The research has established that the participants in this trial must be aged between 18 - 65. There are 63 studies exclusively catering to minors and 405 specifically designed for seniors."

Answered by AI

To what extent can Single Ascending Dose of DISC-3405 be hazardous to participants?

"Since this is a Phase 1 trial, the safety of Single Ascending Dose of DISC-3405 was rated as level 1 due to an absence of substantial data supporting its efficacy and security."

Answered by AI

What are the criteria for enrolling in this clinical research project?

"64 participants are being sought for this study, all of whom must have a healthy background and fall within the 18-65 years age bracket."

Answered by AI

Are there any vacancies to participate in this research project?

"According to the records on clinicaltrials.gov, this particular trial is no longer recruiting participants as it was last updated in September of 2023. Nonetheless, there are 834 other medical studies that remain open and actively seeking candidates at present."

Answered by AI

Who else is applying?

What site did they apply to?
Celerion
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of DISC-3405 in Healthy Volunteers
2023. "A Study of DISC-3405 in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06050915.
All > Omaha
~29 spots leftby Oct 2024
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