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

ImmunoRx Pharma Inc.

Status and phase: Terminated; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Placebo; Drug: IRX-010

Study type: Interventional

Funder types: Industry

Identifiers

NCT06356259

2023-503917-31 (EudraCT Number)

IMMUNRX-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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83 participants in 4 patient groups, including a placebo group

IRX-010 Part A (SAD)

Experimental group

Description:

A single dose of IRX-010 will be administered intravenously

Treatment:

Drug: IRX-010

Placebo Part A (SAD)

Placebo Comparator group

Description:

Placebo administered intravenously

Treatment:

Drug: Placebo

IRX-010 Part B(MAD)

Experimental group

Description:

Multiple doses of IRX-010 will be administered intravenously

Treatment:

Drug: IRX-010

Placebo Part B(MAD)

Placebo Comparator group

Description:

Placebo administered intravenously

Treatment:

Drug: Placebo