Gemini for Chronic Kidney Disease

(PRIME Trial)

No longer recruiting at 2 trial locations

Overseen By Vice President, Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Revelation Biosciences, Inc

Must not be taking: SGLT2i, TNF blockers

Disqualifiers: Uncontrolled diabetes, Hypertension, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Gemini for individuals with chronic kidney disease (CKD) in stages 3 or 4. The goal is to determine if Gemini is safe and well-tolerated when administered as an intravenous infusion. Participants will receive varying doses of Gemini to assess its effects on the body. Suitable candidates include those with CKD who haven't recently changed medications, such as ACE inhibitors or SGLT2 inhibitors, and who can tolerate IV infusions and blood draws. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, especially if you are on drugs like SGLT2 inhibitors, MRAs, TNF inhibitors, or ACE inhibitors that require dose adjustments. It's best to discuss your current medications with the study team to see if any changes are needed.

Is there any evidence suggesting that Gemini is likely to be safe for humans?

Research has shown that Gemini has been tested and found to be safe. In earlier studies, the main safety goals were met, indicating that patients generally tolerated the treatment well. No major safety issues were reported.

The studies administered a single dose of Gemini directly into the vein (IV). Even with varying doses, the treatment was considered safe. This suggests that Gemini is likely safe for people with chronic kidney disease, although ongoing trials will provide more detailed information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic kidney disease?

Unlike the standard of care for chronic kidney disease, which often involves medications like ACE inhibitors or angiotensin II receptor blockers to slow disease progression, Gemini offers a novel approach. Researchers are excited about Gemini because it is administered as an intravenous infusion, allowing for potentially faster and more direct action compared to oral medications. Additionally, Gemini's unique delivery method may enhance its ability to target kidney function more effectively. This innovative treatment has the potential to offer new hope for improved outcomes in chronic kidney disease management.

What evidence suggests that Gemini might be an effective treatment for chronic kidney disease?

Research has shown that Gemini offers promising results for treating chronic kidney disease (CKD). In earlier studies, Gemini significantly reduced inflammation in CKD patients, with effects lasting up to seven days after just one dose. This reduction in inflammation is often linked to slowing the progression of the disease. Additionally, Gemini balanced the body's inflammatory response in patients with stage 3 and 4 CKD. These findings suggest that Gemini could potentially transform CKD treatment by addressing inflammation, a key issue in the disease.

In this trial, participants will receive varying doses of intravenous Gemini to further evaluate its effectiveness and safety. ^{1 3 6 7 8}

Who Is on the Research Team?

Chief Executive Officer

Principal Investigator

Revelation Biosciences, Inc

Are You a Good Fit for This Trial?

Adults with stage 3 or 4 chronic kidney disease can join this trial. It's not for people who need dialysis or have other specific health conditions that aren't listed here.

Inclusion Criteria

I am either not able to have children or I am using birth control.

I am okay with getting IVs and having my blood drawn often.

Willing to comply with the study schedule, restrictions, and requirements

Exclusion Criteria

I have been treated for a deep vein clot in the last 6 months.

My kidney disease is related to or caused by a fast-worsening inflammation of the kidney filtering units and I've used immunosuppressants in the last 6 months.

My BMI is either below 19 or above 40.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive a single intravenous dose of Gemini or placebo, with dose escalation based on safety and tolerability

1 day

1 visit (in-person)

Safety Monitoring

Participants are monitored for safety and tolerability, including adverse events and pharmacokinetics, up to Day 8

8 days

Outpatient visits or telephone follow-ups

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gemini

Trial Overview The trial is testing Gemini, a new drug given through the veins. Participants will either get Gemini or a placebo in one dose, and doctors will watch how safe it is and how the body responds to it.

How Is the Trial Designed?

Group I: Optional High dose of intravenous Gemini infused once over 10-15 minutes. Experimental Treatment 2 Interventions

Cohort 1, 8 subjects (6 active, 2 placebo)

Group II: Mid-level dose of intravenous Gemini infused once over 10-15 minutes. Experimental Treatment 2 Interventions

Cohort 1, 8 subjects (6 active, 2 placebo)

Group III: Low dose of intravenous Gemini infused once over 10-15 minutes. Experimental Treatment 2 Interventions

Cohort 1, 8 subjects (6 active, 2 placebo)

Group IV: High dose of intravenous Gemini infused once over 10-15 minutes. Experimental Treatment 2 Interventions

Cohort 1, 8 subjects (6 active, 2 placebo)

Who Is Running the Clinical Trial?

Revelation Biosciences, Inc

Lead Sponsor

Trials

1

Recruited

40+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06863467

Study Details | NCT06863467 | Evaluation of the Safety ... This study is planned as a placebo controlled, single dose, escalating dose study to evaluate the safety and tolerability of intravenous Gemini in adult ...

2. revbiosciences.com revbiosciences.com/press-releases/revelation-biosciences-inc-completes-dosing-of-patients-in-prime-study

Revelation Biosciences Inc. Completes Dosing of Patients ... Gemini is being developed for multiple indications including as a pretreatment to prevent or reduce the severity and duration of acute kidney ...

3. stocktitan.net stocktitan.net/news/REVB/revelation-biosciences-announces-groundbreaking-top-line-results-zh9eqyiw4w07.html

Revelation Biosciences Announces Groundbreaking Top ... Gemini demonstrated significant reduction in inflammatory markers in CKD patients, with effects lasting 7 days post-dose.

4. cardiorenal.medicalaffairs.bayer.com cardiorenal.medicalaffairs.bayer.com/document/3381

Improving the quality of CKD care with risk prediction and CKD affects 1 in 7 Americans and can lead to progression to dialysis, cardiovascular disease, and early mortality. • Effective interventions exist to slow the.

5. tallahassee.com tallahassee.com/press-release/story/4685/revelation-biosciences-announces-groundbreaking-top-line-results-from-prime-clinical-study/

Revelation Biosciences Announces Groundbreaking Top- ... Gemini normalized the inflammatory response at the cellular level in stage 3 and 4 CKD patients –. – Gemini could potentially revolutionize the treatment of ...

6. ctv.veeva.com ctv.veeva.com/study/evaluation-of-the-safety-and-tolerability-of-gemini-in-subjects-with-stage-3-4-chronic-kidney-diseas

Evaluation of the Safety and Tolerability of Gemini in Subjects ... This study is planned as a placebo controlled, single dose, escalating dose study to evaluate the safety and tolerability of intravenous Gemini in adult ...

7. firstwordpharma.com firstwordpharma.com/story/5918023

Revelation Biosciences Inc. Announces FDA Acceptance ... Positive data from the Phase 1b study will enable a Phase 2 study of Gemini as a preconditioning treatment in patients with CKD to reduce the ...

8. biospace.com biospace.com/press-releases/revelation-biosciences-announces-groundbreaking-top-line-results-from-prime-clinical-study

Revelation Biosciences Announces Groundbreaking Top- ... "The activity observed with a single dose of Gemini in patients is shocking," said Principal Investigator Adam Horeish, MD, Balboa Research. " ...