A Safety and Tolerability Study of RJX Drug Product in Healthy Participants
Condition: Critical Limb Ischemia
MeSH terms: Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional
Phase: Phase 1

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.
    

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.
    

Intervention name(s): RJX; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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).; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science