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Drug Delivery Device

10mg 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
Must not have
Female subjects with a positive pregnancy test at the Screening visit or at Check-in, or who are lactating
Major surgery within 4 weeks before study entry or anticipated during the study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 days

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.
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.
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
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I am a healthy adult between 19 and 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.
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I have not had major surgery in the last 4 weeks and do not expect any during the study.
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I have a significant active infection or a history of serious infections.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events
Secondary study objectives
Pharmacokinetic (PK) Assessments

Trial Design

8Treatment groups
Active Control
Placebo Group
Group I: 10mg SADActive Control1 Intervention
Group II: 5mg 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
~27 spots leftby Nov 2025
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