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Gemini

Phase 1

Renal Insufficiency, Chronic | Small molecule | Nephrology |Revelation Biosciences, Inc.|Last Updated: Oct 29, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Gemini · 1 trial · 3 indications

Phase 1 1
NCT06863467Evaluation of the Safety and Tolerability of Gemini in Subjects With Stage 3-4 Chronic Kidney Disease.Renal Insufficiency, Chronic
COMPLETED40 Analytics
PHASE1COMPLETED
Evaluation of the Safety and Tolerability of Gemini in Subjects With Stage 3-4 Chronic Kidney Disease.
Renal Insufficiency, Chronic
NCT0686346740
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Study Endpoints

Primary Endpoints

Effect of Gemini versus placebo on the incidence of treatment-emergent adverse events.
From time of dose to Day 8

Collection of side effects reported by subjects.

Effect of Gemini vs placebo on electrical activity of the heart.
From time of dose to Day 8

Safety measure for change in the electrical activity of the heart over a period of time using electrodes placed on the skin and recorded by electrocardiogram (ECG) after resting for at least 10 minutes in a quiet setting without distractions in a semi-supine position.

Effect of Gemini versus placebo on blood pressure.
From time of dose to Day 8

Safety measure for change in blood pressure after 5 minutes of rest in a supine, semi-supine or sitting position.

Number of participants with abnormal laboratory hematology test results.
From time of dose to Day 8

Clinically significant changes in blood hematology levels.

Number of participants with abnormal laboratory chemistry tests results.
From time of dose to Day 8

Clinically significant changes in blood chemistry levels.

Number of participants with abnormal laboratory urine tests results.
From time of dose to Day 8

Clinically significant changes in urine.

Effect of Gemini versus placebo on inflammation in the body.
From time of dose to Day 8

Measurement of erythrocyte sedimentation rate in the blood.

Effect of Gemini versus placebo on inflammation.
From time of dose to Day 8

Measurement of N-terminal pro b-type natriuretic peptide in the blood.

Effect of Gemini versus placebo on the inflammatory state of CKD subjects.
From time of dose to Day 8

Measurement of highly sensitive C-reactive Protein in the blood.

Effect of Gemini versus placebo on kidney damage.
From time of dose to Day 8

Measurement of urine albumin creatinine ratio.

Effect of Gemini versus placebo on heart rate.
From time of dose to Day 8

Safety measure for change in heart rate (bpm) after 5 minutes of rest in a supine, semi-supine or sitting position.

Effect of Gemini versus placebo on body temperature.
From time of dose to Day 8

Safety measure for change in body temperature (Celsius) after 5 minutes of rest in a supine, semi-supine or sitting position.

Effect of Gemini versus placebo on respiration.
From time of dose to Day 8

Safety measure for change in respiration rate after 5 minutes of rest in a supine, semi-supine or sitting position.

Number of participants with abnormal physical exam findings.
From time of dose to Day 8

Clinically significance changes in general appearance.

Number of participants with abnormal mental physical exam findings.
From time of dose to Day 8

Clinically significant changes in mental status.

Number of participants with abnormal physical exam findings above the shoulders.
From time of dose to Day 8

Clinically significant changes with HEENT (head, eyes, ears, nose, throat).

Number of participants with abnormal physical exam findings of the skin.
From time of dose to Day 8

Clinically significant changes in the dermatologic system.

Number of participants with abnormal physical exam findings of the heart.
From time of dose to Day 8

Clinically significant changes in the cardiovascular system.

Number of participants with abnormal physical exam findings of the lungs.
From time of dose to Day 8

Clinically significant changes in the respiratory system.

Number of participants with abnormal physical exam findings of the digestive system.
From time of dose to Day 8

Clinically significant changes in the gastrointestinal system.

Number of participants with abnormal physical exam findings of the body's support structure.
From time of dose to Day 8

Clinically significant changes in the musculoskeletal system.

Number of participants with abnormal physical exam findings of the nervous system.
From time of dose to Day 8

Clinically significant changes in the neurological system.

Secondary Endpoints

Peak observed concentration of Gemini.
From time of dose to Day 8
Time for Gemini to reach to maximum observed concentration.
From time of dose to Day 8
Total amount of Gemini that enters the systemic circulation after administration.
From time of dose to Day 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Low dose of intravenous Gemini infused once over 10-15 minutes.EXPERIMENTALCohort 1, 8 subjects (6 active, 2 placebo)
Mid-level dose of intravenous Gemini infused once over 10-15 minutes.EXPERIMENTALCohort 1, 8 subjects (6 active, 2 placebo)
High dose of intravenous Gemini infused once over 10-15 minutes.EXPERIMENTALCohort 1, 8 subjects (6 active, 2 placebo)
Optional High dose of intravenous Gemini infused once over 10-15 minutes.EXPERIMENTALCohort 1, 8 subjects (6 active, 2 placebo)

Interventions

NameTypeDescription
Intravenous GeminiDRUGSingle ascending intravenous dose infused once over 10-15 minutes.
Intravenous placeboDRUGIntravenous sugar solution infused in a single dose over 10-15 minutes.
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Male or female subjects ≥18 to ≤ 80 years of age at screening * Willing and able to provide written informed consent * eGFR of ≥ 15 and ≤ 60 per * Female subjects must be of non-childbearing potential or using a medically acceptable contraceptive regimen * Male subjects must b...

Countries:United States
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Frequently asked questions about Gemini

What is Gemini used for in chronic kidney disease?

Gemini is an investigational small molecule being developed for chronic kidney disease, specifically for patients with stage 3-4 chronic kidney disease and renal insufficiency. It is currently in Phase 1 clinical development and has not been approved by the FDA.

Who makes Gemini?

Gemini is being developed by Revelation Biosciences, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol REVB. The company is conducting clinical research on this investigational drug for chronic kidney disease.

What phase is Gemini in?

Gemini is in Phase 1 clinical development. A Phase 1 clinical trial evaluating the safety and tolerability of Gemini in subjects with stage 3-4 chronic kidney disease has been completed. The drug remains investigational and is not yet approved for any use.

What clinical trials is Gemini in?

Gemini has one completed Phase 1 clinical trial registered as NCT06863467, titled 'Evaluation of the Safety and Tolerability of Gemini in Subjects With Stage 3-4 Chronic Kidney Disease.' The trial enrolled 40 participants in the United States and was a controlled, randomized study.

Is Gemini the same as any other drug?

Gemini is the primary name for this investigational drug developed by Revelation Biosciences. No alternative names have been reported for this asset in clinical development for chronic kidney disease.