Evaluation of the Safety and Tolerability of Gemini in Subjects With Stage 3-4 Chronic Kidney Disease.

NCT06863467 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: RVL-CKD01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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. Pharmacokinetics will be evaluated and measurements of the effect of Gemini on pharmacodynamic activity will be measured to assess changes in potential pharmacodynamic markers.

Conditions

Renal Insufficiency, Chronic; Chronic Kidney Disease stage3; Chronic Kidney Disease stage4

Outcome Measures

Primary Outcomes (22)

• Effect of Gemini versus placebo on the incidence of treatment-emergent adverse events.

  Collection of side effects reported by subjects.

  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.

  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.

  From time of dose to Day 8

• Number of participants with abnormal laboratory hematology test results.

  Clinically significant changes in blood hematology levels.

  From time of dose to Day 8

• Number of participants with abnormal laboratory chemistry tests results.

  Clinically significant changes in blood chemistry levels.

  From time of dose to Day 8

• Number of participants with abnormal laboratory urine tests results.

  Clinically significant changes in urine.

  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.

  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.

  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.

  From time of dose to Day 8

• Effect of Gemini versus placebo on kidney damage.

  Measurement of urine albumin creatinine ratio.

  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.

  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.

  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.

  From time of dose to Day 8

• Number of participants with abnormal physical exam findings.

  Clinically significance changes in general appearance.

  From time of dose to Day 8

• Number of participants with abnormal mental physical exam findings.

  Clinically significant changes in mental status.

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  From time of dose to Day 8

Secondary Outcomes (7)

• 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

• Total Gemini exposure across time.

  From time of dose to Day 8

• The amount of time required for the plasma concentration of Gemini to decline by 50% .

  From time of dose to Day 8

Other Outcomes (4)

• Effect of Gemini versus placebo on serum biomarkers for traditional assessment of inflammation.

  From time of dose to Day 8

• Effect of Gemini versus placebo on serum biomarkers that measure activity.

  From time of dose to Day 8

• Effect of Gemini versus placebo on urine biomarkers.

  From time of dose to Day 8

Study Arms (4)

Low dose of intravenous Gemini infused once over 10-15 minutes.

EXPERIMENTAL

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

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)

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)

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)

Drug: Intravenous Gemini; Drug: Intravenous placebo

Interventions

Intravenous Gemini DRUG

Single ascending intravenous dose infused once over 10-15 minutes.

Also known as: Phosphorylated hexaacylated disaccharide, PHAD

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 placebo DRUG

Intravenous sugar solution infused in a single dose over 10-15 minutes.

Also known as: D5W

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Revelation Biosciences, Inc: lead

Study Sites (3)

California Institute of Renal Research

Chula Vista, California, 91911, United States

Location

California Institute of Renal Research

La Mesa, California, 92942, United States

Location

Clinical Advance Center, PLLC

San Antonio, Texas, 78212, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chief Executive Officer

  Revelation Biosciences, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 7, 2025
• Study Start: January 20, 2025
• Primary Completion: July 22, 2025
• Study Completion: July 22, 2025
• Last Updated: October 29, 2025

Record last verified: 2025-10

Locations

US (3)