Critical Limb IschemiaPhase 1NCT03680105

A Safety and Tolerability Study of RJX Drug Product in Healthy Participants

A Phase 1 study testing RJX in people with Critical Limb Ischemia, run by Reven Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Designed as a single center, two-part, double-blind, placebo-controlled, randomized study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RJX in healthy participants. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Critical Limb Ischemia
What is being tested?: RJX
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 76 participants
Where: 1 siteUnited States
Study dates: 24 Aug 2018to 15 Jan 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy male and female participants aged 18 to 50 years inclusive (Cohort 1 to Cohort 5) or 51 to 70 years inclusive (Cohort 6 only),at the time of screening;
Have a body mass index of 18 kg/m2 to 35 kg/m2, inclusive, at screening. In addition, weight cannot exceed 132 kg;
Have negative screening assessment for viral hepatitis (hepatitis B or hepatitis C) and human immunodeficiency virus;
Have negative routine urine drug screen and negative alcohol breath test at screening and Day -1;
A female participant is eligible to participate if she is not pregnant,not breastfeeding, and at least 1 of the following conditions applies:
Not of childbearing potential, defined as surgically sterile (documented hysterectomy, bilateral salpingectomy, tubal ligation or bilateral oophorectomy) or postmenopausal (no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; however, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient);

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Of childbearing potential and agrees to use 2 highly effective methods of contraception consistently during the treatment period and for at least 60 days after the last dose of investigational product;
A male participant with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception during the treatment period and for at least 60 days after the last dose of investigational product and refrains from donating sperm during this period;
Clinical laboratory test results within normal reference range for the population or investigator site, or any results that are judged to be not clinically significant by the investigator;
Venous access sufficient to allow for blood sampling per the protocol;
Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures;
Given written informed consent prior to any study procedures being performed

Who cannot join

Have a history of clinically relevant cardiovascular disease, cancer, respiratory, hepatic, renal, gastrointestinal, endocrine (diabetes), hematological, or neurological disorders. Cohort 6 only - elderly participants with well controlled hypercholesterolemia on a stable dose of statin therapy or well controlled hypertension on a stable dose of antihypertensive medication(s), excluding diuretics, are allowed in Cohort 6 per the clinical judgment of the investigator.
Have impaired renal function (defined as estimated glomerular filtration rate <90 cc/min/1.73m2 Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) creatinine equation at screening);
Have a hsCRP above 1.25 × upper limit of normal;
Have a clinically significant abnormality in the 12-lead electrocardiogram (ECG) or prolongation of corrected QT interval by Fredericia (QTcF) >440 ms in males and >450 ms in females;
Have a supine systolic blood pressure (BP) greater than 140 mm Hg or a diastolic BP greater than 90 mm Hg. Up to 2 additional measurements may be undertaken after an appropriate resting interval at screening to confirm eligibility;
Are currently enrolled in a clinical trial involving an investigational product, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study;

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Have received an investigational product within the last 3 months;
Have suspected allergies to RJX, related compounds, or any components of the formulation, or history of significant atopy;
Regularly use known drugs of abuse and/or show positive findings on drug screening or Day -1;
Are women who are pregnant, intend to become pregnant, or are lactating;
Participants will be excluded for using any of the following medication:
aspirin, multivitamins/vitamins or mineral preparations within 14 days prior to investigational product administration or 24 hours post the last infusion;
prescription, herbal or over the counter medications within 14 days of investigational product administration, with the exception of:
simple analgesics such as paracetamol, excluding aspirin
oral non-steroidal anti-inflammatory drugs
thyroid treatment, estrogen replacement therapy
hormonal contraception
Statins and anti-hypertensives are permitted for elderly participants in Cohort 6 (Part 1) - see inclusion criteria #1
Have donated blood of more than 500 mL within 4 weeks prior to study enrollment;
Have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65) and 14 units per week (males over 65 and females) or are unwilling to stop alcohol consumption for 24 hours prior to study site admission (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits). Participants must have a of negative alcohol breath test at Day -1 and no evidence of alcohol abuse in the previous 12 months, defined as > 21 weekly units for males up to age 65 and > 14 weekly units for males over 65 and females;
Have smoked cigarettes in the last 90 days (including occasional smokers who have smoked more than 5 cigarettes per month within the last 90 days);
In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study;
Are investigator site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted;
Are Reven employees or employees of third-party organizations involved with the study who require exclusion of their employees.

Trial locations and contacts

1 site in 1 country.

United States1 site

ICON Early Phase Services
San Antonio, Texas, 78209

Other trials in United States

About this study

Official title: A Phase 1, Double-blind, Placebo-controlled, Randomized, Two-Part, Ascending Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Rejuveinix (RJX) in Healthy Participants

Read the detailed description

Part 1 is designed as a Single Ascending Dose (SAD) escalation study with 6 cohorts. Participants will undertake a screening visit between Day -21 and Day -1 to determine eligibility in the study. Those participants that meet the eligibility criteria will be admitted to the study site on the day prior to dosing (Day -1). Participants will receive a single dose of investigational product via IV infusion on Day 1. The first cohort will include the initial dosing of a sentinel group. The remaining participants in Cohort 1 will be dosed if, in the opinion of the investigator or delegate, there are no significant safety concerns identified in the sentinel participants within the first 24 hours after administration of the dose. Participants will be confined to the study site from Day -1 to Day 2 (24 hours post dose) and then required to return to the study site on Day 5 for a final follow up visit. Safety and PK assessments will be performed at selected time points throughout the study.

Part 2 is designed as a Multiple Ascending Dose (MAD) escalation study with 3 cohorts. The MAD arm of the study will commence in parallel with Cohort 6 of Part 1 following completion and review of safety and PK findings for Cohorts 1, 2, 3, 4, and 5 in Part 1. Participants will undertake a screening visit between Day -21 and Day -1 to determine eligibility in the study. Those participants that meet the eligibility criteria will be admitted to the study site on the day prior to dosing (Day -1). Participants will be randomly assigned to receive 1 of 3 proposed doses of investigational product via IV infusion every day for 7 days.Participants will be confined to the study site from Day -1 to Day 8 (24 hours post the final dose on Day 7) and then return to the study site on Day 12 for a final follow up visit. Safety and PK assessments will be performed at selected time points throughout the study.

Conditions: Critical Limb Ischemia
Being tested: RJX, Placebo
Medical subject headings: Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RJXDrug
RJX is an IV infusion formulation. The appropriate RJX dose is calculated based on mL/kg. The administration dose is prepared by adding the appropriate RJX dose to 0.9% sterile saline such that a constant volume of 100 mL per IV infusion is obtained. Infusion time is 100 mL over 45 minutes (+/- 5 minutes).
PlaceboDrug
Matching placebo will be normal saline. To maintain the blind, a sleeve will cover the infusion bag and line such that the appearance will be identical to RJX administration.

Study groups in NCT03680105
Study group	Role	What they receive
Part 1; Cohort 1; RJX or Placebo	Experimental	Participants in Part 1; Cohort 1 will receive a single 0.024 mL/kg dose of RJX or matching placebo on Day 1. Receives: Drug: RJX; Drug: Placebo
Part 1; Cohort 2; RJX or Placebo	Experimental	Participants in Part 1; Cohort 2 will receive a single 0.076 mL/kg dose of RJX or matching placebo on Day 1. Receives: Drug: RJX; Drug: Placebo
Part 1; Cohort 3; RJX or Placebo	Experimental	Participants in Part 1; Cohort 3 will receive a single 0.240 mL/kg dose of RJX or matching placebo on Day 1. Receives: Drug: RJX; Drug: Placebo
Part 1; Cohort 4; RJX or Placebo	Experimental	Participants in Part 1; Cohort 4 will receive a single 0.5 mL/kg dose of RJX or matching placebo on Day 1. Receives: Drug: RJX; Drug: Placebo
Part 1; Cohort 5; RJX or Placebo	Experimental	Participants in Part 1; Cohort 5 will receive a single 0.759 mL/kg dose of RJX or matching placebo on Day 1. Receives: Drug: RJX; Drug: Placebo
Part 1; Cohort 6; RJX or Placebo	Experimental	Participants in Part 1; Cohort 6 will receive a single dose of RJX or matching placebo, to be determined following review of safety and PK data from Cohorts 1 to 5, on Day 1. Receives: Drug: RJX; Drug: Placebo
Part 2; Cohort 1; RJX or Placebo	Experimental	Participants in Part 2; Cohort 1 will receive a dose of RJX or matching placebo, determined based on the findings of Part 1, every day for 7 days. The Part 2; Cohort 1 dose will be 1 log down from the maximum tolerated dose determined in Part 1 or at a dose determined to be safe and well tolerated in Part 1 with an acceptable PK profile. Receives: Drug: RJX; Drug: Placebo
Part 2; Cohort 2; RJX or Placebo	Experimental	Participants in Part 2; Cohort 2 will receive an escalated dose of RJX or matching placebo, determined based on the findings of Part 1, every day for 7 days. Receives: Drug: RJX; Drug: Placebo
Part 2; Cohort 3; RJX or Placebo	Experimental	Participants in Part 2; Cohort 3 will receive an escalated dose of RJX or matching placebo, determined based on the findings of Part 1, every day for 7 days. Receives: Drug: RJX; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment-related Adverse Events (TEAE) Reporting of RJX
Number of participants with indicated AEs receiving RJX as assessed by CTCAE v4 03
Measured: Up to Day 5 for Part 1 and Up to Day 12 for Part 2
Safety and Tolerability of RJX as Assessed by Electrocardiograms (ECGs).
Number of participants with abnormal and clinically significant findings based on ECG.
Measured: Up to Day 2 for Part 1 and Up to Day 8 for Part 2
Safety and Tolerability of RJX as Assessed by Neurological Examinations.
Number of participants with clinically significant values and actual changes from baseline of continuous neurological assessments.
Measured: Up to Day 5 for Part 1 and Up to Day 12 for Part 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Aug 201815 Jan 2019

First posted21 Sep 2018
Study start24 Aug 2018
Primary completion15 Jan 2019
Study completion15 Jan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Critical Limb IschemiaStudies 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
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03680105
Sponsor's protocol ID: RPI003
Status last verified: Apr 2020
First submitted: 29 Aug 2018
Last updated: 27 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Uckun FM, Saeed M, Awili M, Ozercan IH, Qazi S, Lee C, Shibli A, Skolnick AW, Prusmack A, Varon J, Barrera CI, Orhan C, Volk M, Sahin K. Evaluation of the potential of Rejuveinix plus dexamethasone against sepsis. Future Microbiol. 2022 Oct;17:1217-1229. doi: 10.2217/fmb-2022-0044. Epub 2022 Sep 2.
PubMed 36052743
Uckun FM, Orhan C, Tuzcu M, Durmus AS, Ozercan IH, Volk M, Sahin K. RJX Improves Wound Healing in Diabetic Rats. Front Endocrinol (Lausanne). 2022 Jun 2;13:874291. doi: 10.3389/fendo.2022.874291. eCollection 2022.
PubMed 35721744
Uckun FM, Carlson J, Orhan C, Powell J, Pizzimenti NM, van Wyk H, Ozercan IH, Volk M, Sahin K. Rejuveinix Shows a Favorable Clinical Safety Profile in Human Subjects and Exhibits Potent Preclinical Protective Activity in the Lipopolysaccharide-Galactosamine Mouse Model of Acute Respiratory Distress Syndrome and Multi-Organ Failure. Front Pharmacol. 2020 Nov 10;11:594321. doi: 10.3389/fphar.2020.594321. eCollection 2020.
PubMed 33244300

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Double-blind, Placebo-controlled, Randomized, Two-Part, Ascending Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Rejuveinix (RJX) in Healthy Participants
ClinicalTrials.gov ID: NCT03680105
Acronym / sponsor ID: RPI003
Conditions: Critical Limb Ischemia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: Reven Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Collaborators: ICON plc, ERT: Clinical Trial Technology Solutions
Study start: 24 Aug 2018 (actual)
Primary completion: 15 Jan 2019 (actual)
Study completion: 15 Jan 2019 (actual)
First posted: 21 Sep 2018 (actual)
Results: Posted 14 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 9

Arm	Type	Receives
Part 1; Cohort 1; RJX or Placebo	Experimental	Drug: RJX, Drug: PlaceboParticipants in Part 1; Cohort 1 will receive a single 0.024 mL/kg dose of RJX or matching placebo on Day 1.
Part 1; Cohort 2; RJX or Placebo	Experimental	Drug: RJX, Drug: PlaceboParticipants in Part 1; Cohort 2 will receive a single 0.076 mL/kg dose of RJX or matching placebo on Day 1.
Part 1; Cohort 3; RJX or Placebo	Experimental	Drug: RJX, Drug: PlaceboParticipants in Part 1; Cohort 3 will receive a single 0.240 mL/kg dose of RJX or matching placebo on Day 1.
Part 1; Cohort 4; RJX or Placebo	Experimental	Drug: RJX, Drug: PlaceboParticipants in Part 1; Cohort 4 will receive a single 0.5 mL/kg dose of RJX or matching placebo on Day 1.
Part 1; Cohort 5; RJX or Placebo	Experimental	Drug: RJX, Drug: PlaceboParticipants in Part 1; Cohort 5 will receive a single 0.759 mL/kg dose of RJX or matching placebo on Day 1.
Part 1; Cohort 6; RJX or Placebo	Experimental	Drug: RJX, Drug: PlaceboParticipants in Part 1; Cohort 6 will receive a single dose of RJX or matching placebo, to be determined following review of safety and PK data from Cohorts 1 to 5, on Day 1.
Part 2; Cohort 1; RJX or Placebo	Experimental	Drug: RJX, Drug: PlaceboParticipants in Part 2; Cohort 1 will receive a dose of RJX or matching placebo, determined based on the findings of Part 1, every day for 7 days. The Part 2; Cohort 1 dose will be 1 log down from the maximum tolerated dose determined in Part 1 or at a dose determined to be safe and well tolerated in Part 1 with an acceptable PK profile.
Part 2; Cohort 2; RJX or Placebo	Experimental	Drug: RJX, Drug: PlaceboParticipants in Part 2; Cohort 2 will receive an escalated dose of RJX or matching placebo, determined based on the findings of Part 1, every day for 7 days.
Part 2; Cohort 3; RJX or Placebo	Experimental	Drug: RJX, Drug: PlaceboParticipants in Part 2; Cohort 3 will receive an escalated dose of RJX or matching placebo, determined based on the findings of Part 1, every day for 7 days.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Healthy male and female participants aged 18 to 50 years inclusive (Cohort 1 to Cohort 5) or 51 to 70 years inclusive (Cohort 6 only),at the time of screening;
Have a body mass index of 18 kg/m2 to 35 kg/m2, inclusive, at screening. In addition, weight cannot exceed 132 kg;
Have negative screening assessment for viral hepatitis (hepatitis B or hepatitis C) and human immunodeficiency virus;
Have negative routine urine drug screen and negative alcohol breath test at screening and Day -1;
A female participant is eligible to participate if she is not pregnant,not breastfeeding, and at least 1 of the following conditions applies:

Key exclusion criteria (24 listed)

Have a history of clinically relevant cardiovascular disease, cancer, respiratory, hepatic, renal, gastrointestinal, endocrine (diabetes), hematological, or neurological disorders. Cohort 6 only - elderly participants with well controlled hypercholesterolemia on a stable dose of statin therapy or well controlled hypertension on a stable dose of antihypertensive medication(s), excluding diuretics, are allowed in Cohort 6 per the clinical judgment of the investigator.
Have impaired renal function (defined as estimated glomerular filtration rate <90 cc/min/1.73m2 Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) creatinine equation at screening);
Have a hsCRP above 1.25 × upper limit of normal;
Have a clinically significant abnormality in the 12-lead electrocardiogram (ECG) or prolongation of corrected QT interval by Fredericia (QTcF) >440 ms in males and >450 ms in females;
Have a supine systolic blood pressure (BP) greater than 140 mm Hg or a diastolic BP greater than 90 mm Hg. Up to 2 additional measurements may be undertaken after an appropriate resting interval at screening to confirm eligibility;

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
RJXRJX is an IV infusion formulation. The appropriate RJX dose is calculated based on mL/kg. The administration dose is prepared by adding the appropriate RJX dose to 0.9% sterile saline such that a constant volume of 100 mL per IV infusion is obtained. Infusion time is 100 mL over 45 minutes (+/- 5 minutes).	Drug	Part 1; Cohort 1; RJX or Placebo, Part 1; Cohort 2; RJX or Placebo, Part 1; Cohort 3; RJX or Placebo, Part 1; Cohort 4; RJX or Placebo, Part 1; Cohort 5; RJX or Placebo, Part 1; Cohort 6; RJX or Placebo, Part 2; Cohort 1; RJX or Placebo, Part 2; Cohort 2; RJX or Placebo, Part 2; Cohort 3; RJX or Placebo
PlaceboMatching placebo will be normal saline. To maintain the blind, a sleeve will cover the infusion bag and line such that the appearance will be identical to RJX administration.	Drug	Part 1; Cohort 1; RJX or Placebo, Part 1; Cohort 2; RJX or Placebo, Part 1; Cohort 3; RJX or Placebo, Part 1; Cohort 4; RJX or Placebo, Part 1; Cohort 5; RJX or Placebo, Part 1; Cohort 6; RJX or Placebo, Part 2; Cohort 1; RJX or Placebo, Part 2; Cohort 2; RJX or Placebo, Part 2; Cohort 3; RJX or Placebo

Primary outcome

Treatment-related Adverse Events (TEAE) Reporting of RJX
Time frame: Up to Day 5 for Part 1 and Up to Day 12 for Part 2
Number of participants with indicated AEs receiving RJX as assessed by CTCAE v4 03
Safety and Tolerability of RJX as Assessed by Electrocardiograms (ECGs).
Time frame: Up to Day 2 for Part 1 and Up to Day 8 for Part 2
Number of participants with abnormal and clinically significant findings based on ECG.
Safety and Tolerability of RJX as Assessed by Neurological Examinations.
Time frame: Up to Day 5 for Part 1 and Up to Day 12 for Part 2
Number of participants with clinically significant values and actual changes from baseline of continuous neurological assessments.

Results and safety

Results posted to the registry on 14 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1; Cohort 1; RJX or Placebo	8	8
Part 1; Cohort 2; RJX or Placebo	8	8
Part 1; Cohort 3; RJX or Placebo	8	8
Part 1; Cohort 4; RJX or Placebo	8	8
Part 1; Cohort 5; RJX or Placebo	8	8
Part 1; Cohort 6; RJX or Placebo	12	12
Part 2; Cohort 1; RJX or Placebo	8	8
Part 2; Cohort 2; RJX or Placebo	8	8
Part 2; Cohort 3; RJX or Placebo	8	8

Primary outcome: Treatment-related Adverse Events (TEAE) Reporting of RJX

Time frame: Up to Day 5 for Part 1 and Up to Day 12 for Part 2. Count of participants. Unit: Participants

Measure	Part 1; Placebo n = 13	Part 1; Cohort 1; RJX n = 6	Part 1; Cohort 2; RJX n = 6	Part 1; Cohort 3; RJX n = 6	Part 1; Cohort 4; RJX n = 6	Part 1; Cohort 5; RJX n = 6	Part 1; Cohort 6; RJX n = 9	Part 2; Placebo n = 6	Part 2; Cohort 1; RJX n = 6	Part 2; Cohort 2; RJX n = 6	Part 2; Cohort 3; RJX n = 6
Mild TEAE: With TEAE	2	1	2	0	2	2	0	1	1	3	2
Mild TEAE: Without TEAE	11	5	4	6	4	4	9	5	5	3	4
Moderate TEAE: With TEAE	0	0	0	0	1	1	0	1	0	0	1
Moderate TEAE: Without TEAE	13	6	6	6	5	5	9	5	6	6	5
Severe TEAE: With TEAE	0	0	0	0	0	0	0	0	0	0	0
Severe TEAE: Without TEAE	13	6	6	6	6	6	9	6	6	6	6
Related TEAE: With TEAE	0	1	1	0	2	2	0	1	0	2	0
Related TEAE: Without TEAE	13	5	5	6	4	4	9	5	6	4	6

Primary outcome: Safety and Tolerability of RJX as Assessed by Electrocardiograms (ECGs).

Time frame: Up to Day 2 for Part 1 and Up to Day 8 for Part 2. Count of participants. Unit: Participants

Measure	Part 1; Placebo n = 13	Part 1; Cohort 1; RJX n = 6	Part 1; Cohort 2; RJX n = 6	Part 1; Cohort 3; RJX n = 6	Part 1; Cohort 4; RJX n = 6	Part 1; Cohort 5; RJX n = 6	Part 1; Cohort 6; RJX n = 9	Part 2; Placebo n = 6	Part 2; Cohort 1; RJX n = 6	Part 2; Cohort 2; RJX n = 6	Part 2; Cohort 3; RJX n = 6
Value	0	0	0	0	0	0	0	0	0	0	0

Population analysed: Counts of 12-lead safety ECG interpretations across Intent to Treat (ITT) population showed no notable changes when compared to baseline for either study part.

Primary outcome: Safety and Tolerability of RJX as Assessed by Neurological Examinations.

Time frame: Up to Day 5 for Part 1 and Up to Day 12 for Part 2. Count of participants. Unit: Participants

Measure	Part 1; Placebo n = 13	Part 1; Cohort 1; RJX n = 6	Part 1; Cohort 2; RJX n = 6	Part 1; Cohort 3; RJX n = 6	Part 1; Cohort 4; RJX n = 6	Part 1; Cohort 5; RJX n = 6	Part 1; Cohort 6; RJX n = 9	Part 2; Placebo n = 6	Part 2; Cohort 1; RJX n = 6	Part 2; Cohort 2; RJX n = 6	Part 2; Cohort 3; RJX n = 6
Value	0	0	0	0	0	0	0	0	0	1	0

Population analysed: Analysis based on Intent to Treat (ITT) population across Part 1 and Part 2, all cohorts. Only 1 subject, one incidence, for the study; presented on Day 12, Principal Investigator considered clinically significant and a mild TEAE considered unlikely related to RJX.

Adverse events

Time frame: Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1; Placebo	0 of 13 (0%)	2 of 13 (15.4%)	0 of 13
Part 1; Cohort 1; RJX	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part 1; Cohort 2; RJX	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part 1; Cohort 3; RJX	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Part 1; Cohort 4; RJX	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part 1; Cohort 5; RJX	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part 1; Cohort 6; RJX	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Part 2; Placebo	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part 2; Cohort 1; RJX	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part 2; Cohort 2; RJX or Placebo	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part 2; Cohort 3; RJX or Placebo	0 of 6 (0%)	3 of 6 (50%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36052743Uckun FM, Saeed M, Awili M, Ozercan IH, Qazi S, Lee C, Shibli A, Skolnick AW, Prusmack A, Varon J, Barrera CI, Orhan C, Volk M, Sahin K. Evaluation of the potential of Rejuveinix plus dexamethasone against sepsis. Future Microbiol. 2022 Oct;17:1217-1229. doi: 10.2217/fmb-2022-0044. Epub 2022 Sep 2.
Derived from this study: PubMed 35721744Uckun FM, Orhan C, Tuzcu M, Durmus AS, Ozercan IH, Volk M, Sahin K. RJX Improves Wound Healing in Diabetic Rats. Front Endocrinol (Lausanne). 2022 Jun 2;13:874291. doi: 10.3389/fendo.2022.874291. eCollection 2022.
Derived from this study: PubMed 33244300Uckun FM, Carlson J, Orhan C, Powell J, Pizzimenti NM, van Wyk H, Ozercan IH, Volk M, Sahin K. Rejuveinix Shows a Favorable Clinical Safety Profile in Human Subjects and Exhibits Potent Preclinical Protective Activity in the Lipopolysaccharide-Galactosamine Mouse Model of Acute Respiratory Distress Syndrome and Multi-Organ Failure. Front Pharmacol. 2020 Nov 10;11:594321. doi: 10.3389/fphar.2020.594321. eCollection 2020.

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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.

Dennis A Ruff, MD principal investigator

ICON plc

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RJX in people with Critical Limb Ischemia, run by Reven Pharmaceuticals, Inc. at 1 site 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 12 inclusion and 24 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 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Treatment-related Adverse Events (TEAE) Reporting of RJX (time frame: Up to Day 5 for Part 1 and Up to Day 12 for Part 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03680105, which also lists 3 linked publications.

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 27 Apr 2020.