Clinical trial NCT06356259: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Intravenous Administration of IRX-010 in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: ImmunoRx Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-10
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with Serious Adverse Events
timeFrame: Baseline upto Day 168
measure: Number of participants with Treatment-Emergent Adverse Events
timeFrame: Baseline upto Day 168
Secondary outcomes:
measure: Pharmacokinetics(PK): Area under Curve(AUC)
timeFrame: Baseline upto Day 168
measure: Pharmacokinetics(PK): Maximum Concentration (Cmax)
timeFrame: Baseline upto Day 168
measure: Pharmacokinetics(PK): Half-Life (t½)
timeFrame: Baseline upto Day 168
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: ICON
Study officials:
affiliation: ImmunoRx Pharma Inc.
name: ImmunoRx Pharma,Inc
role: STUDY_DIRECTOR
References: