A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Intravenous Administration of IRX-010 in Healthy Participants

A Randomised, Placebo-Controlled, Double-blind, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Intravenous Administration of IRX-010 in Healthy Participants

The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics with intravenous(IV) administration of IRX-010 in Healthy Participants.

Study Overview

• Status: Terminated
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Placebo; Drug: IRX-010

Detailed Description

This is a single and multiple ascending dose, proof of concept study assessing the safe and tolerable dose of IRX-010 in healthy participants. Approximately 81 healthy participants will be enrolled in up to 9 cohorts. The study is conducted in two parts (part A and part B) with 6 single ascending dose (Part A - SAD) cohorts of 9 participants per cohort and 3 multiple ascending dose (Part B - MAD) cohorts of 9 participants per cohort.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728
    • ICON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or Female participants who are healthy as determined by medical history and physical evaluation.
• Have clinical laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically. significant by the investigator at screening and enrolment.
• Have an estimated glomerular filtration rate ≥60 mL/minute/1.73 m2 at screening and enrolment.
• Have venous access sufficient to allow for blood sampling as per the protocol. Weight
• Have a body mass index of 18.0 to 32.0 kg/m2 inclusive, at screening.

Exclusion Criteria:

• Have a history or presence of clinically significant medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, haematological, renal, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality that, in the judgment of the investigator, indicates a medical problem that would preclude study participation.
• Have history (within past 5 years) of, or presence of, uncontrolled asthma, significant rheumatological or autoimmune diseases, including but not limited to systemic lupus erythematosus, RA, Sjogren's Syndrome, or vasculitis; or hereditary angioedema, or common variable immune deficiency.
• Have had lymphoma, leukaemia, or any malignancy within the past 5 years.
• Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (if known) (whichever is longer) prior to dosing
• Have active or latent Tuberculosis (TB), based on a positive medical history, examination, chest x-rays (as per local TB screening guidelines), and/or TB test results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IRX-010 Part A (SAD); A single dose of IRX-010 will be administered intravenously	Drug: IRX-010; Administered IV
Placebo Comparator: Placebo Part A (SAD); Placebo administered intravenously	Drug: Placebo; Administered IV
Experimental: IRX-010 Part B(MAD); Multiple doses of IRX-010 will be administered intravenously	Drug: IRX-010; Administered IV
Placebo Comparator: Placebo Part B(MAD); Placebo administered intravenously	Drug: Placebo; Administered IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Serious Adverse Events	Evaluation of Safety and Tolerability of IRX-010	Baseline upto Day 168
Number of participants with Treatment-Emergent Adverse Events	Evaluation of Safety and Tolerability of IRX-010	Baseline upto Day 168

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics(PK): Area under Curve(AUC)	PK: AUC of IRX-010	Baseline upto Day 168
Pharmacokinetics(PK): Maximum Concentration (Cmax)	PK: Cmax of IRX-010	Baseline upto Day 168
Pharmacokinetics(PK): Half-Life (t½)	PK: t½ of IRX-010	Baseline upto Day 168

Collaborators and Investigators

• Sponsor: ImmunoRx Pharma Inc.
• Investigators: Study Director: ImmunoRx Pharma,Inc, ImmunoRx Pharma Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2023
• Primary Completion (Actual): January 23, 2025
• Study Completion (Actual): January 23, 2025

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IMMUNRX-01; 2023-503917-31 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No