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OPT101 for Type 1 Diabetes

Phase 1
Waitlist Available
Research Sponsored by Op-T LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

Study Summary

This trial tests if a drug is safe & effective for people by measuring its effects on the body and immune system.

Eligible Conditions
  • Type 1 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 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
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Secondary outcome measures
Serum samples collected to determine AUC0-t
Serum samples collected to determine CL/F
Serum samples collected to determine Cmax
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: OPT101 2.8 mg/kg and PlaceboExperimental Treatment1 Intervention
9 subjects (6 investigational product:3 placebo)
Group II: OPT101 1.1 mg/kg and PlaceboExperimental Treatment1 Intervention
9 subjects (6 investigational product:3 placebo)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OPT101
2022
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Op-T LLCLead Sponsor
1 Previous Clinical Trials
15 Total Patients Enrolled
Lisa Boswell, MSStudy DirectorOP-T
~8 spots leftby Jun 2025
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