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OPT101 for Type 1 Diabetes

Phase 1

Recruiting

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

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)

Do I qualify?Apply below to find out

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

Frequently Asked Questions

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

What is the total number of participants involved in this research?

"Affirmative. According to clinicaltrials.gov, this research project is currently welcoming participants after first being posted on September 27th 2022 and most recently updated on March 22nd 2023. The study requires 18 volunteers from 2 distinct medical centres."

Answered by AI

How secure is this remedy for individuals?

"Due to its Phase 1 status, with limited supporting data for efficacy and safety, our team at Power rated this treatment a score of 1."

Answered by AI

Could I partake in this investigation?

"Those with type 1 diabetes and aged between 18-60 can apply to join this clinical study, which is limited to only 18 participants."

Answered by AI

Are there any vacancies for enrollees in this experiment?

"Affirmative. Clinicaltrials.gov reveals that this research, published on September 27th 2022 and revised on March 22nd 2023 is currently in need of 18 participants at two separate medical centres."

Answered by AI

Do persons younger than 65 years qualify for this clinical trial?

"This medical research requires participants aged 18 to 60. For those below the age of consent, there are 221 studies available and 947 for senior citizens above 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

OPT101 in Type 1 Diabetes Patients

2022. "OPT101 in Type 1 Diabetes Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05428943.