drugset / Trial / NCT03680105
A Safety and Tolerability Study of RJX Drug Product in Healthy Participants
Phase 1
Completed
76 enrolled
Reven Pharmaceuticals, Inc.
ERT: Clinical Trial Technology Solutions · collabICON plc · collab
RandomizedParallel-groupDouble-blindBasic science
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.
Timeline
- Start
- 2018-08-24
- Primary completion
- 2019-01-15
- Completion
- 2019-01-15
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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rejuveinix | Unknown | 0.024 unknown | Intravenous |
| Subject | Rejuveinix | Unknown | 0.076 unknown | Intravenous |
| Subject | Rejuveinix | Unknown | 0.24 unknown | Intravenous |
| Subject | Rejuveinix | Unknown | 0.5 unknown | Intravenous |
| Subject | Rejuveinix | Unknown | 0.759 unknown | Intravenous |