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

Phase 1

Terminated

• Conditions: Healthy Participants
• Interventions: Drug: IRX-010; Drug: Placebo

• Registration Number: NCT06356259
• Lead Sponsor: ImmunoRx Pharma Inc.

Brief Summary

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

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 Timeline

• Study Start: 2023-06-07
• Study First Submitted: 2024-04-04
• Study First Submitted QC: 2024-04-04
• Study First Posted: 2024-04-10
• Primary Completion: 2025-01-23
• Study Completion: 2025-01-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 83

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
IRX-010 Part B(MAD)	IRX-010	Multiple doses of IRX-010 will be administered intravenously
IRX-010 Part A (SAD)	IRX-010	A single dose of IRX-010 will be administered intravenously
Placebo Part A (SAD)	Placebo	Placebo administered intravenously
Placebo Part B(MAD)	Placebo	Placebo administered intravenously

Primary Outcome Measures

Name	Time	Method
Number of participants with Serious Adverse Events	Baseline upto Day 168	Evaluation of Safety and Tolerability of IRX-010
Number of participants with Treatment-Emergent Adverse Events	Baseline upto Day 168	Evaluation of Safety and Tolerability of IRX-010

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ICON; 🇳🇱 Groningen, Netherlands