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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
Must not have
Monogenic forms of diabetes or type 2 diabetes
History of chronic gastrointestinal disease, possible or confirmed celiac disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a genetic form of diabetes or type 2 diabetes.
Select...
I have a long-term gut problem or celiac disease.
Select...
My child does not follow a high-fiber or vegetarian diet nor takes fiber supplements.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Measurement of adverse events from the date of the first dose through 12 weeks of R-5280 tolerance
Secondary study objectives
Measurement of clinical activity and to determine the gut microbiome profile in youth with recently diagnosed Type 1 Diabetes

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)

Find a Location

Who is running the clinical trial?

Rise Therapeutics LLCLead Sponsor
4 Previous Clinical Trials
141 Total Patients Enrolled
~12 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
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