Renal Insufficiency, ChronicPhase 1/2PRIMENCT06863467
Evaluation of the Safety and Tolerability of Gemini in Subjects With Stage 3-4 Chronic Kidney Disease.
A Phase 1/2 study testing Intravenous Gemini in people with Renal Insufficiency, Chronic and Chronic Kidney Disease stage3, run by Revelation Biosciences, Inc at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Insufficiency, Chronic, Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
- What is being tested?
- Intravenous Gemini
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Jan 2025to 22 Jul 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 be surgically sterile or using a medically acceptable contraceptive regimen
- Willing and able to tolerate IV infusions and multiple blood draws
- Willing to comply with the study schedule, restrictions, and requirements
Who cannot join
- CKD Secondary to or associated with any of the following:
- History of rapidly progressive glomerulonephritis (RPGN)
- Glomerulonephritis requiring any use of immunosuppression in the last 6 months
- Body mass index ≤ 19.0 kg/m2 or ≥ 40.0 kg/m2
- Currently taking a sodium/glucose cotransporter-2 inhibitor (SGLT2i) or non-steroidal mineralocorticoidantagonist (MRA) requiring dose adjustments within 12 weeks prior to Day 1 or if dose is anticipated to change
- Currently taking tumor necrosis factor (TNF) inhibitors, TNF blocker, interleukin-6 (IL-6) blockers or interleukin-1 (IL-1) blocking drugs
Show all 35Show fewer
- Receiving steroids or any other immunosuppressive agent or anti-inflammatory drugs
- Currently taking an angiotensin-converting enzyme inhibitor (ACEi) and/or an angiotensin II receptor blocker (ARB) requiring dose adjustments
- Any use of direct renin inhibitors;
- Live vaccinations within 3 months prior to the start of the trial or expected during the trial
- Received a mRNA vaccine within 4 weeks
- Uncontrolled diabetes (HbA1c > 11.0%)
- Clinical laboratory results of ALT and/or AST that are > 2.5X upper limit of normal (ULN)
- Clinical Laboratory results of Total bilirubin that is > 1.5X the ULN
- Has a Urine Albumin-to-Creatinine Ratio (uACR) level > 3000 mg/g
- Age-related macular degeneration (AMD), diabetic macular edema or active diabetic proliferative retinopathy that was likely to require treatment during the trial
- Uncontrolled hypertension
- New York Heart Association Class IV congestive heart failure
- Any organ transplant recipient, or a planned transplant during the study
- Currently has known Hepatitis B or uncontrolled human immunodeficiency virus (HIV) or uncontrolled Hepatitis C virus (HCV) that may interfere with the study
- Myocardial infarction, acute coronary syndrome, or stroke within 6 months
- History of myelodysplastic syndrome
- History of deep vein thrombosis (DVT) that required active treatment in the last 6 months. Superficial thrombosis is not excluded
- History of hemosiderosis or hemochromatosis
- History of rheumatoid arthritis or systemic lupus erythematosus (SLE)
- History of drug use that may interfere with the study or study result
- Red cell transfusion within 12 weeks
- History of malignancy in the previous 5 years except for curatively resected basal cell carcinoma of skin, squamous cell carcinoma of skin or cervical carcinoma in situ
- Coronavirus disease 2019 (COVID-19) diagnosis within 1 month
- Evidence of active infection unless subject is appropriate for this study per the Investigator
- Life expectancy less than 6 months
- Intolerance to study medication
- Pregnancy or lactation
- Received treatment with any investigational product in any clinical study within 30 days prior to administration of study drug or five half-lives, whichever is longer
- In the opinion of the Investigator or identified Sub-I(s), any other disease processes or confounding variables that would inappropriately alter the outcome of the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
California Institute of Renal Research
Chula Vista, California, 91911
California Institute of Renal Research
La Mesa, California, 92942
Clinical Advance Center, PLLC
San Antonio, Texas, 78212
About this study
Official title: A Phase 1b, Randomized, Placebo-Controlled, Single-Blind, Single Ascending Dose Study in Subjects With Stage 3 or 4 Chronic Kidney Disease
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.
Read the detailed description
Design: Randomized, Placebo Controlled, Single Blind, Single-Ascending Dose Study in Patients with Stage 3-4 CKD.
This study is planned as 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. This study will enroll up to 40 subjects in up to 5 cohorts. Each cohort will consist of 8 unique subjects, 6 assigned to Gemini and 2 assigned to placebo. All subjects will provide written informed consent and be screened for eligibility before enrollment. All eligibility criteria must be met prior to dosing.
On Day 1, each study subject will receive a single IV dose (each total dose volume = 20 mL) via syringe pump for at least 10 minutes but not longer than 15 minutes and as per the institution's standard method. Time 0 starts once the entire dose is administered and the line has been flushed to ensure any residual drug is delivered.
A Safety Review Committee (SRC) will assess safety and tolerability including AEs, after at least 6 subjects in each cohort have completed Day 8 to determine the subsequent cohort dose. If a grade 3 or higher adverse event is not experienced, as determined by the SRC, or the criteria for stopping dosing has not been met at a given cohort dose level, dose escalation will proceed to the next cohort and dose level.
Dosing will continue until any cohort experiences a dose limiting toxicity (DLT), defined as a dose that causes any grade 3 or higher adverse event, or stopping criteria is met or the highest dose as determined in the Phase 1 study has been tolerated. If a dose is stopped due to a DLT or stopping criteria, cohorts scheduled at a higher dose will not be utilized. The SRC will meet to review safety and tolerability data and may determine if a lower dose can be given. This dose will be documented in the minutes and a dose recommendation memo which will be provided to the clinical sites.
Once the maximum tolerated dose is determined, the dose will be repeated (Cohort 4) for a total of 16 subjects dosed at the highest level tolerated. The repeated dose cohort will consist of 8 unique subjects, 6 assigned to Gemini and 2 assigned to placebo. If the maximum tolerated dose is reached within the first 2 cohorts, the dose will be repeated until a minimum of 32 subjects are enrolled.
If the highest dose determined in the Phase 1 study is tolerated, optional higher dosing of may be administered as determined by the SRC, or the same dose will be repeated.
All visits will be conducted as an outpatient or via telephone.
- Conditions
- Renal Insufficiency, Chronic, Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
- Being tested
- Intravenous Gemini, Intravenous placebo
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous GeminiDrug
Also called Phosphorylated hexaacylated disaccharide, PHAD
Single ascending intravenous dose infused once over 10-15 minutes.
Intravenous placeboDrug
Also called D5W
Intravenous sugar solution infused in a single dose over 10-15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Low dose of intravenous Gemini infused once over 10-15 minutes. | Experimental | Cohort 1, 8 subjects (6 active, 2 placebo) Receives: Drug: Intravenous Gemini; Drug: Intravenous placebo |
| Mid-level dose of intravenous Gemini infused once over 10-15 minutes. | Experimental | Cohort 1, 8 subjects (6 active, 2 placebo) Receives: Drug: Intravenous Gemini; Drug: Intravenous placebo |
| High dose of intravenous Gemini infused once over 10-15 minutes. | Experimental | Cohort 1, 8 subjects (6 active, 2 placebo) Receives: Drug: Intravenous Gemini; Drug: Intravenous placebo |
| Optional High dose of intravenous Gemini infused once over 10-15 minutes. | Experimental | Cohort 1, 8 subjects (6 active, 2 placebo) Receives: Drug: Intravenous Gemini; Drug: Intravenous placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Gemini versus placebo on the incidence of treatment-emergent adverse events.
Collection of side effects reported by subjects.
Measured: From time of dose to Day 8
Effect of Gemini vs placebo on electrical activity of the heart.
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.
Measured: From time of dose to Day 8
Effect of Gemini versus placebo on blood pressure.
Safety measure for change in blood pressure after 5 minutes of rest in a supine, semi-supine or sitting position.
Measured: From time of dose to Day 8
Number of participants with abnormal laboratory hematology test results.
Clinically significant changes in blood hematology levels.
Measured: From time of dose to Day 8
Number of participants with abnormal laboratory chemistry tests results.
Clinically significant changes in blood chemistry levels.
Measured: From time of dose to Day 8
Number of participants with abnormal laboratory urine tests results.
Clinically significant changes in urine.
Measured: From time of dose to Day 8
Effect of Gemini versus placebo on inflammation in the body.
Measurement of erythrocyte sedimentation rate in the blood.
Measured: From time of dose to Day 8
Effect of Gemini versus placebo on inflammation.
Measurement of N-terminal pro b-type natriuretic peptide in the blood.
Measured: From time of dose to Day 8
Effect of Gemini versus placebo on the inflammatory state of CKD subjects.
Measurement of highly sensitive C-reactive Protein in the blood.
Measured: From time of dose to Day 8
Effect of Gemini versus placebo on kidney damage.
Measurement of urine albumin creatinine ratio.
Measured: From time of dose to Day 8
Effect of Gemini versus placebo on heart rate.
Safety measure for change in heart rate (bpm) after 5 minutes of rest in a supine, semi-supine or sitting position.
Measured: From time of dose to Day 8
Effect of Gemini versus placebo on body temperature.
Safety measure for change in body temperature (Celsius) after 5 minutes of rest in a supine, semi-supine or sitting position.
Measured: From time of dose to Day 8
Effect of Gemini versus placebo on respiration.
Safety measure for change in respiration rate after 5 minutes of rest in a supine, semi-supine or sitting position.
Measured: From time of dose to Day 8
Number of participants with abnormal physical exam findings.
Clinically significance changes in general appearance.
Measured: From time of dose to Day 8
Number of participants with abnormal mental physical exam findings.
Clinically significant changes in mental status.
Measured: From time of dose to Day 8
Number of participants with abnormal physical exam findings above the shoulders.
Clinically significant changes with HEENT (head, eyes, ears, nose, throat).
Measured: From time of dose to Day 8
Number of participants with abnormal physical exam findings of the skin.
Clinically significant changes in the dermatologic system.
Measured: From time of dose to Day 8
Number of participants with abnormal physical exam findings of the heart.
Clinically significant changes in the cardiovascular system.
Measured: From time of dose to Day 8
Number of participants with abnormal physical exam findings of the lungs.
Clinically significant changes in the respiratory system.
Measured: From time of dose to Day 8
Number of participants with abnormal physical exam findings of the digestive system.
Clinically significant changes in the gastrointestinal system.
Measured: From time of dose to Day 8
Number of participants with abnormal physical exam findings of the body's support structure.
Clinically significant changes in the musculoskeletal system.
Measured: From time of dose to Day 8
Number of participants with abnormal physical exam findings of the nervous system.
Clinically significant changes in the neurological system.
Measured: From time of dose to Day 8
Secondary outcomes (7)
Peak observed concentration of Gemini.
Measurement of maximum observed concentration (Cmax) in blood over intervals of time.
Measured: From time of dose to Day 8
Time for Gemini to reach to maximum observed concentration.
Measurement of time to maximum observed concentration (Tmax) over intervals of time.
Measured: From time of dose to Day 8
Total amount of Gemini that enters the systemic circulation after administration.
Measurement of area under the concentration-time curve (AUC0-t) over intervals of time.
Measured: From time of dose to Day 8
Total Gemini exposure across time.
Measurement of area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) over intervals of time.
Measured: From time of dose to Day 8
The amount of time required for the plasma concentration of Gemini to decline by 50% .
Measurement if apparent terminal elimination half-life (t1/2) over intervals of time.
Measured: From time of dose to Day 8
Volume of Gemini required to be uniformly distributed throughout the body.
Measurement of blood volume of distribution (Vd) over intervals of time.
Measured: From time of dose to Day 8
Rate which Gemini is removed from the human system.
Measurement of elimination rate constant (Kel) over intervals of time.
Measured: From time of dose to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start20 Jan 2025
- Primary completion22 Jul 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revelation Biosciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Executive Officer, Study director, Revelation Biosciences, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863467
- Sponsor's protocol ID
- RVL-CKD01
- Acronym
- PRIME
- Status last verified
- Oct 2025
- First submitted
- 21 Feb 2025
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Placebo-Controlled, Single-Blind, Single Ascending Dose Study in Subjects With Stage 3 or 4 Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06863467
- Acronym / sponsor ID
- PRIME / RVL-CKD01
- Conditions
- Renal Insufficiency, Chronic, Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Revelation Biosciences, IncIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Design: Randomized, Placebo Controlled, Single Blind, Single-Ascending Dose Study in Patients with Stage 3-4 CKD.
This study is planned as 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. This study will enroll up to 40 subjects in up to 5 cohorts. Each cohort will consist of 8 unique subjects, 6 assigned to Gemini and 2 assigned to placebo. All subjects will provide written informed consent and be screened for eligibility before enrollment. All eligibility criteria must be met prior to dosing.
On Day 1, each study subject will receive a single IV dose (each total dose volume = 20 mL) via syringe pump for at least 10 minutes but not longer than 15 minutes and as per the institution's standard method. Time 0 starts once the entire dose is administered and the line has been flushed to ensure any residual drug is delivered.
A Safety Review Committee (SRC) will assess safety and tolerability including AEs, after at least 6 subjects in each cohort have completed Day 8 to determine the subsequent cohort dose. If a grade 3 or higher adverse event is not experienced, as determined by the SRC, or the criteria for stopping dosing has not been met at a given cohort dose level, dose escalation will proceed to the next cohort and dose level.
Dosing will continue until any cohort experiences a dose limiting toxicity (DLT), defined as a dose that causes any grade 3 or higher adverse event, or stopping criteria is met or the highest dose as determined in the Phase 1 study has been tolerated. If a dose is stopped due to a DLT or stopping criteria, cohorts scheduled at a higher dose will not be utilized. The SRC will meet to review safety and tolerability data and may determine if a lower dose can be given. This dose will be documented in the minutes and a dose recommendation memo which will be provided to the clinical sites.
Once the maximum tolerated dose is determined, the dose will be repeated (Cohort 4) for a total of 16 subjects dosed at the highest level tolerated. The repeated dose cohort will consist of 8 unique subjects, 6 assigned to Gemini and 2 assigned to placebo. If the maximum tolerated dose is reached within the first 2 cohorts, the dose will be repeated until a minimum of 32 subjects are enrolled.
If the highest dose determined in the Phase 1 study is tolerated, optional higher dosing of may be administered as determined by the SRC, or the same dose will be repeated.
All visits will be conducted as an outpatient or via telephone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose of intravenous Gemini infused once over 10-15 minutes. | Experimental | Drug: Intravenous Gemini, Drug: Intravenous placeboCohort 1, 8 subjects (6 active, 2 placebo) |
| Mid-level dose of intravenous Gemini infused once over 10-15 minutes. | Experimental | Drug: Intravenous Gemini, Drug: Intravenous placeboCohort 1, 8 subjects (6 active, 2 placebo) |
| High dose of intravenous Gemini infused once over 10-15 minutes. | Experimental | Drug: Intravenous Gemini, Drug: Intravenous placeboCohort 1, 8 subjects (6 active, 2 placebo) |
| Optional High dose of intravenous Gemini infused once over 10-15 minutes. | Experimental | Drug: Intravenous Gemini, Drug: Intravenous placeboCohort 1, 8 subjects (6 active, 2 placebo) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 be surgically sterile or using a medically acceptable contraceptive regimen
Key exclusion criteria (35 listed)
- CKD Secondary to or associated with any of the following:
- Body mass index ≤ 19.0 kg/m2 or ≥ 40.0 kg/m2
- Currently taking a sodium/glucose cotransporter-2 inhibitor (SGLT2i) or non-steroidal mineralocorticoidantagonist (MRA) requiring dose adjustments within 12 weeks prior to Day 1 or if dose is anticipated to change
- Currently taking tumor necrosis factor (TNF) inhibitors, TNF blocker, interleukin-6 (IL-6) blockers or interleukin-1 (IL-1) blocking drugs
- Receiving steroids or any other immunosuppressive agent or anti-inflammatory drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous GeminiAlso: Phosphorylated hexaacylated disaccharide, PHADSingle ascending intravenous dose infused once over 10-15 minutes. | Drug | High dose of intravenous Gemini infused once over 10-15 minutes., Low dose of intravenous Gemini infused once over 10-15 minutes., Mid-level dose of intravenous Gemini infused once over 10-15 minutes., Optional High dose of intravenous Gemini infused once over 10-15 minutes. |
| Intravenous placeboAlso: D5WIntravenous sugar solution infused in a single dose over 10-15 minutes. | Drug | High dose of intravenous Gemini infused once over 10-15 minutes., Low dose of intravenous Gemini infused once over 10-15 minutes., Mid-level dose of intravenous Gemini infused once over 10-15 minutes., Optional High dose of intravenous Gemini infused once over 10-15 minutes. |
Primary outcome
Effect of Gemini versus placebo on the incidence of treatment-emergent adverse events.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From time of dose to Day 8
Clinically significant changes in blood hematology levels.
Number of participants with abnormal laboratory chemistry tests results.
Time frame: From time of dose to Day 8
Clinically significant changes in blood chemistry levels.
Number of participants with abnormal laboratory urine tests results.
Time frame: From time of dose to Day 8
Clinically significant changes in urine.
Effect of Gemini versus placebo on inflammation in the body.
Time frame: From time of dose to Day 8
Measurement of erythrocyte sedimentation rate in the blood.
Effect of Gemini versus placebo on inflammation.
Time frame: 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.
Time frame: 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.
Time frame: From time of dose to Day 8
Measurement of urine albumin creatinine ratio.
Effect of Gemini versus placebo on heart rate.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From time of dose to Day 8
Clinically significance changes in general appearance.
Number of participants with abnormal mental physical exam findings.
Time frame: From time of dose to Day 8
Clinically significant changes in mental status.
Number of participants with abnormal physical exam findings above the shoulders.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From time of dose to Day 8
Clinically significant changes in the neurological system.
7 secondary outcomes
Peak observed concentration of Gemini.
Time frame: From time of dose to Day 8
Time for Gemini to reach to maximum observed concentration.
Time frame: From time of dose to Day 8
Total amount of Gemini that enters the systemic circulation after administration.
Time frame: From time of dose to Day 8
Total Gemini exposure across time.
Time frame: From time of dose to Day 8
The amount of time required for the plasma concentration of Gemini to decline by 50% .
Time frame: From time of dose to Day 8
Volume of Gemini required to be uniformly distributed throughout the body.
Time frame: From time of dose to Day 8
Rate which Gemini is removed from the human system.
Time frame: From time of dose to Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Executive Officer study director
Revelation Biosciences, Inc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intravenous Gemini in people with Renal Insufficiency, Chronic and Chronic Kidney Disease stage3, run by Revelation Biosciences, Inc at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Gemini versus placebo on the incidence of treatment-emergent adverse events. (time frame: From time of dose to Day 8). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025; AzTrials last refreshed its copy on 8 Nov 2026.