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Gemini

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06863467Evaluation of the Safety and Tolerability of Gemini in Subjects With Stage 3-4 Chronic Kidney Disease.PHASE1 COMPLETED 40 — — Jan 20, 2025Jul 22, 2025Oct 29, 20253 United States
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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 — 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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