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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-07

Study Completion Date

2025-01-23

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IRX-010 Part A (SAD)

A single dose of IRX-010 will be administered intravenously

Group Type EXPERIMENTAL

IRX-010

Intervention Type DRUG

Administered IV

Placebo Part A (SAD)

Placebo administered intravenously

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered IV

IRX-010 Part B(MAD)

Multiple doses of IRX-010 will be administered intravenously

Group Type EXPERIMENTAL

IRX-010

Intervention Type DRUG

Administered IV

Placebo Part B(MAD)

Placebo administered intravenously

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered IV

Interventions

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IRX-010

Administered IV

Intervention Type DRUG

Placebo

Administered IV

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes