NCT03680105

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

Completed Phase 1 Results posted Last updated 27 April 2020

What this trial tests

Phase 1 trial testing RJX in Critical Limb Ischemia in 76 participants. Completed in 15 January 2019.

Timeline

24 August 2018

Primary endpoint
15 January 2019

15 January 2019

Quick facts

Lead sponsor	Reven Pharmaceuticals, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	76
Start date	24 August 2018
Primary completion	15 January 2019
Estimated completion	15 January 2019
Sites	1 location across United States

Drugs / interventions tested

• RJX — full drug profile →
• Placebo

Conditions studied

• Critical Limb Ischemia — all drugs for Critical Limb Ischemia →

Sponsor

Reven Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 70, any sex, with Critical Limb Ischemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Mild TEAE

Group	Value	95% CI
Part 1; Placebo	2
Part 1; Cohort 1; RJX	1
Part 1; Cohort 2; RJX	2
Part 1; Cohort 3; RJX	0
Part 1; Cohort 4; RJX	2
Part 1; Cohort 5; RJX	2
Part 1; Cohort 6; RJX	0
Part 2; Placebo	1
Part 2; Cohort 1; RJX	1
Part 2; Cohort 2; RJX	3
Part 2; Cohort 3; RJX	2
Part 1; Placebo	11
Part 1; Cohort 1; RJX	5
Part 1; Cohort 2; RJX	4
Part 1; Cohort 3; RJX	6
Part 1; Cohort 4; RJX	4
Part 1; Cohort 5; RJX	4
Part 1; Cohort 6; RJX	9
Part 2; Placebo	5
Part 2; Cohort 1; RJX	5
Part 2; Cohort 2; RJX	3
Part 2; Cohort 3; RJX	4

Moderate TEAE

Group	Value	95% CI
Part 1; Placebo	0
Part 1; Cohort 1; RJX	0
Part 1; Cohort 2; RJX	0
Part 1; Cohort 3; RJX	0
Part 1; Cohort 4; RJX	1
Part 1; Cohort 5; RJX	1
Part 1; Cohort 6; RJX	0
Part 2; Placebo	1
Part 2; Cohort 1; RJX	0
Part 2; Cohort 2; RJX	0
Part 2; Cohort 3; RJX	1
Part 1; Placebo	13
Part 1; Cohort 1; RJX	6
Part 1; Cohort 2; RJX	6
Part 1; Cohort 3; RJX	6
Part 1; Cohort 4; RJX	5
Part 1; Cohort 5; RJX	5
Part 1; Cohort 6; RJX	9
Part 2; Placebo	5
Part 2; Cohort 1; RJX	6
Part 2; Cohort 2; RJX	6
Part 2; Cohort 3; RJX	5

Severe TEAE

Group	Value	95% CI
Part 1; Placebo	0
Part 1; Cohort 1; RJX	0
Part 1; Cohort 2; RJX	0
Part 1; Cohort 3; RJX	0
Part 1; Cohort 4; RJX	0
Part 1; Cohort 5; RJX	0
Part 1; Cohort 6; RJX	0
Part 2; Placebo	0
Part 2; Cohort 1; RJX	0
Part 2; Cohort 2; RJX	0
Part 2; Cohort 3; RJX	0
Part 1; Placebo	13
Part 1; Cohort 1; RJX	6
Part 1; Cohort 2; RJX	6
Part 1; Cohort 3; RJX	6
Part 1; Cohort 4; RJX	6
Part 1; Cohort 5; RJX	6
Part 1; Cohort 6; RJX	9
Part 2; Placebo	6
Part 2; Cohort 1; RJX	6
Part 2; Cohort 2; RJX	6
Part 2; Cohort 3; RJX	6

Related TEAE

Group	Value	95% CI
Part 1; Placebo	0
Part 1; Cohort 1; RJX	1
Part 1; Cohort 2; RJX	1
Part 1; Cohort 3; RJX	0
Part 1; Cohort 4; RJX	2
Part 1; Cohort 5; RJX	2
Part 1; Cohort 6; RJX	0
Part 2; Placebo	1
Part 2; Cohort 1; RJX	0
Part 2; Cohort 2; RJX	2
Part 2; Cohort 3; RJX	0
Part 1; Placebo	13
Part 1; Cohort 1; RJX	5
Part 1; Cohort 2; RJX	5
Part 1; Cohort 3; RJX	6
Part 1; Cohort 4; RJX	4
Part 1; Cohort 5; RJX	4
Part 1; Cohort 6; RJX	9
Part 2; Placebo	5
Part 2; Cohort 1; RJX	6
Part 2; Cohort 2; RJX	4
Part 2; Cohort 3; RJX	6

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

Group	Value	95% CI
Part 1; Placebo	0
Part 1; Cohort 1; RJX	0
Part 1; Cohort 2; RJX	0
Part 1; Cohort 3; RJX	0
Part 1; Cohort 4; RJX	0
Part 1; Cohort 5; RJX	0
Part 1; Cohort 6; RJX	0
Part 2; Placebo	0
Part 2; Cohort 1; RJX	0
Part 2; Cohort 2; RJX	0
Part 2; Cohort 3; RJX	0

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

Group	Value	95% CI
Part 1; Placebo	0
Part 1; Cohort 1; RJX	0
Part 1; Cohort 2; RJX	0
Part 1; Cohort 3; RJX	0
Part 1; Cohort 4; RJX	0
Part 1; Cohort 5; RJX	0
Part 1; Cohort 6; RJX	0
Part 2; Placebo	0
Part 2; Cohort 1; RJX	0
Part 2; Cohort 2; RJX	1
Part 2; Cohort 3; RJX	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1; Placebo

Serious: 0/13 (0%)

Deaths: 0/13

Part 1; Cohort 1; RJX

Serious: 0/6 (0%)

Deaths: 0/6

Part 1; Cohort 2; RJX

Serious: 0/6 (0%)

Deaths: 0/6

Part 1; Cohort 3; RJX

Serious: 0/6 (0%)

Deaths: 0/6

Part 1; Cohort 4; RJX

Serious: 0/6 (0%)

Deaths: 0/6

Part 1; Cohort 5; RJX

Serious: 0/6 (0%)

Deaths: 0/6

Part 1; Cohort 6; RJX

Serious: 0/9 (0%)

Deaths: 0/9

Part 2; Placebo

Serious: 0/6 (0%)

Deaths: 0/6

Part 2; Cohort 1; RJX

Serious: 0/6 (0%)

Deaths: 0/6

Part 2; Cohort 2; RJX or Placebo

Serious: 0/6 (0%)

Deaths: 0/6

Part 2; Cohort 3; RJX or Placebo

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (17 terms — click to expand)

Reaction	System	Part 1; Placebo	Part 1; Cohort 1; RJX	Part 1; Cohort 2; RJX	Part 1; Cohort 3; RJX	Part 1; Cohort 4; RJX	Part 1; Cohort 5; RJX	Part 1; Cohort 6; RJX	Part 2; Placebo	Part 2; Cohort 1; RJX	Part 2; Cohort 2; RJX or P…	Part 2; Cohort 3; RJX or P…
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
Infusion site discomfort	General disorders	—	—	—	—	—	—	—	—	—	—	—
Infusion Site Pain	General disorders	—	—	—	—	—	—	—	—	—	—	—
Infusion Site Reaction	General disorders	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
Delayed Sleep Phase	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
Clonus	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Pain In Extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Blood Pressure Systolic Decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—
Hypotension	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
Upper Respiratory Tract Infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
C-reactive Protein Increased	Investigations	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT03680105 adverse events section.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Uckun FM, Carlson J, Orhan C, Powell J, et al · · 2020 · cited 15× · PMID 33244300 · DOI 10.3389/fphar.2020.594321
2. The rat as an animal model in chronic wound research: An update.
   Ghanbari M, Salkovskiy Y, Carlson MA. · · 2024 · cited 14× · PMID 38848945 · DOI 10.1016/j.lfs.2024.122783
3. RJX Improves Wound Healing in Diabetic Rats.
   Uckun FM, Orhan C, Tuzcu M, Durmus AS, et al · · 2022 · cited 7× · PMID 35721744 · DOI 10.3389/fendo.2022.874291
4. Evaluation of the potential of Rejuveinix plus dexamethasone against sepsis.
   Uckun FM, Saeed M, Awili M, Ozercan IH, et al · · 2022 · cited 1× · PMID 36052743 · DOI 10.2217/fmb-2022-0044
5. Clinical and Non-clinical Proof of Concept Supporting the Development of RJX As an Adjunct to Standard of Care Against Severe COVID-19
   Uckun FM, Saeed M, Awili M, Ozercan IH, et al · · 2022 · DOI 10.1101/2022.02.12.22270748
6. Rejuveinix Mitigates Sepsis-Associated Oxidative Stress in the Brain:  Clinical Impact Potential in COVID-19 and Nervous System Disorders
   Uckun FM, Tuzcu M, Gitterle M, Volk M, et al · · 2021 · DOI 10.21203/rs.3.rs-501838/v1
7. Rejuveinix Mitigates Sepsis-Associated Oxidative Stress in the Brain of Mice: Clinical Impact Potential in COVID-19 and Nervous System Disorders
   Uckun FM, Tuzcu M, Gitterle M, Volk M, et al · · 2021 · DOI 10.1101/2021.01.03.424883