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Drug Delivery Device

5mg SAD for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by Biora Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy, adult male or female, 19-50 years of age
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 days
Awards & highlights

Study Summary

This trial is testing the safety, effectiveness, and how the body processes a new drug called BT-600 in healthy participants. The drug is designed to release a medication called tofacitinib in the

Who is the study for?
This trial is for healthy adults who can participate in a study lasting up to 7 weeks, including screening. Participants will test BT-600, a new drug/device combo designed to deliver medication directly to the colon.Check my eligibility
What is being tested?
The trial tests the safety and effects of BT-600 when given in different doses. It's randomized and double-blind, meaning neither participants nor researchers know who gets the real treatment or placebo.See study design
What are the potential side effects?
Since this is an early-phase trial for a new product, potential side effects are being investigated but may include digestive discomfort or reactions related to swallowing the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a healthy adult between 19 and 50 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 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
Adverse Events
Secondary outcome measures
Pharmacokinetic (PK) Assessments

Trial Design

8Treatment groups
Active Control
Placebo Group
Group I: 5mg SADActive Control1 Intervention
Group II: 10mg SADActive Control1 Intervention
Group III: 10mg MADActive Control1 Intervention
Group IV: 5mg MADActive Control1 Intervention
Group V: 5mg SAD placeboPlacebo Group1 Intervention
Group VI: 10mg SAD placeboPlacebo Group1 Intervention
Group VII: 10mg MAD placeboPlacebo Group1 Intervention
Group VIII: 5mg MAD placeboPlacebo Group1 Intervention

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Biora Therapeutics, Inc.Lead Sponsor
Clinical Program LeaderStudy DirectorBiora Therapeutics, Inc.
1 Previous Clinical Trials
47 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 individuals older than 60 years of age eligible to participate in this study's recruitment process?

"Individuals seeking to participate in this research study must be between 19 and 50 years old as per the eligibility requirements."

Answered by AI

Are there any ongoing efforts to enroll participants for this study?

"The current status on clinicaltrials.gov indicates that this investigation is actively pursuing potential participants. The trial was initially listed on 1/11/2024 and most recently revised on 2/16/2024."

Answered by AI

Has the Food and Drug Administration authorized the use of 5 milligrams for Single Ascending Dose studies?

"According to our team at Power, the safety rating for 5mg SAD is rated as 1 on a scale from 1 to 3. This assessment aligns with it being in Phase I of the trial, indicating there is minimal data supporting its safety and effectiveness."

Answered by AI

Do I meet the necessary criteria to participate in this experimental study?

"To qualify for participation in this research, individuals must be healthy and between 19 and 50 years old. The study is accepting approximately 48 participants."

Answered by AI

Who else is applying?

What site did they apply to?
Celerion
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
BT-600 Single and Multiple Ascending Oral Doses in Healthy Adult Subjects
2024. "BT-600 Single and Multiple Ascending Oral Doses in Healthy Adult Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06275464.
All > Omaha
~32 spots leftby Apr 2025
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