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

NCT06356259 | Terminated Phase 1

• 2 other identifiers: IMMUNRX-012023-503917-31
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Pharmacokinetics(PK): Area under Curve(AUC)

  Baseline upto Day 168

• Pharmacokinetics(PK): Maximum Concentration (Cmax)

  Baseline upto Day 168

• Pharmacokinetics(PK): Half-Life (t½)

  Baseline upto Day 168

Study Arms (4)

IRX-010 Part A (SAD)

EXPERIMENTAL

A single dose of IRX-010 will be administered intravenously

Drug: IRX-010

Placebo Part A (SAD)

PLACEBO COMPARATOR

Placebo administered intravenously

Drug: Placebo

IRX-010 Part B(MAD)

EXPERIMENTAL

Multiple doses of IRX-010 will be administered intravenously

Drug: IRX-010

Placebo Part B(MAD)

PLACEBO COMPARATOR

Placebo administered intravenously

Drug: Placebo

Interventions

IRX-010 DRUG

Administered IV

IRX-010 Part A (SAD); IRX-010 Part B(MAD)

Placebo DRUG

Administered IV

Placebo Part A (SAD); Placebo Part B(MAD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ImmunoRx Pharma Inc.: lead

Study Sites (1)

ICON

Groningen, Provincie Groningen, 9728, Netherlands

Location

Study Officials

• ImmunoRx Pharma,Inc

  ImmunoRx Pharma Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 10, 2024
• Study Start: June 7, 2023
• Primary Completion: January 23, 2025
• Study Completion: January 23, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)