Gemini for Chronic Kidney Disease

(PRIME Trial)

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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Gemini is being evaluated in a placebo controlled, single dose, escalating dose study to evaluate the safety and tolerability of intravenous Gemini in adult subjects with stage 3 or 4 chronic kidney disease. Pharmacokinetics will be evaluated and measurements of the effect of Gemini on pharmacodynamic activity will be measured to assess changes in potential pharmacodynamic markers.

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.

Research Team

Chief Executive Officer

Principal Investigator

Revelation Biosciences, Inc

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+