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Monoclonal Antibodies

R-5280 (HAMS-AB) for Type 1 Diabetes (R-5280 Trial)

Phase 1

Recruiting

Research Sponsored by Rise Therapeutics LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newly Diagnosed children (age 11-17 years old)

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

R-5280 Trial Summary

This trial studies how well HAMS-AB helps people with newly diagnosed Type 1 Diabetes manage their condition.

Who is the study for?

This trial is for children aged 11-17 recently diagnosed with Type 1 Diabetes, who are not overweight and willing to follow a healthy diabetic diet. They can't have other forms of diabetes, ongoing infections or recent antibiotic use, compromised immunity, steroid or immunosuppressant use in the last six months, be pregnant, on high-fiber/vegetarian diets or have certain allergies.Check my eligibility

What is being tested?

The study tests R-5280's safety and how well it works in kids newly diagnosed with Type 1 Diabetes compared to a placebo. It aims to see if R-5280 can help manage their condition better.See study design

What are the potential side effects?

Possible side effects of R-5280 aren't detailed but will include monitoring for any adverse reactions that may arise during the trial as it assesses tolerance and safety.

R-5280 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a child aged 11-17 years newly diagnosed with the condition.

R-5280 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measurement of adverse events from the date of the first dose through 12 weeks of R-5280 tolerance

Secondary outcome measures

Measurement of clinical activity and to determine the gut microbiome profile in youth with recently diagnosed Type 1 Diabetes

R-5280 Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active ComparatorActive Control1 Intervention

R-5280, Taken Twice a day, orally with food for 12 weeks (84 days)

Group II: Placebo ComparatorPlacebo Group1 Intervention

Food starch, taken twice a day, orally with food for 12 weeks (84 days)

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Rise Therapeutics LLCLead Sponsor

3 Previous Clinical Trials

108 Total Patients Enrolled

Frequently Asked Questions

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

What qualifications must individuals meet to partake in this research?

"The requirements to enroll in this clinical study are a diagnosis of Type 1 diabetes and an age between 11-17. Currently, 39 participants are needed for the trial."

Answered by AI

Does this trial accommodate those of advanced age?

"According to the eligibility requirements, patients must be between 11 and 17 years of age. In total, there are 219 clinical trials involving minors and 958 for senior citizens."

Answered by AI

What is the current standing of Active Comparator with regards to FDA approval?

"Although there is limited evidence of safety or efficacy, the risk associated with Active Comparator was evaluated as a 1."

Answered by AI

Are there still slots available for prospective participants of this trial?

"Clinicaltrials.gov provides evidence that this trial is not currently recruiting patients, despite first being posted on November 1st 2023 and last edited on September 21st 2023. Though no further volunteers are needed for this particular study, there are 1297 other clinical trials actively seeking participants at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

R-5280 in Newly Diagnosed Patients With Type 1 Diabetes

2023. "R-5280 in Newly Diagnosed Patients With Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06057454.

All > Type 1 Diabetes > Indianapolis