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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06356259
• Other study ID #: IMMUNRX-01
• Secondary ID: 2023-503917-31
• Status: Recruiting
• Phase: Phase 1
• Start date: June 7, 2023
• Est. completion date: January 22, 2025

Study information

• Verified date: April 2024
• Source: ImmunoRx Pharma Inc.
• Contact: Study Director ImmunoRx Pharma,Inc
• Phone: 3176517036
• Email: choruspharma[@]lists.lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 81
• Est. completion date: January 22, 2025
• Est. primary completion date: January 22, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• IRX-010
Administered IV
• Placebo
Administered IV

Locations

Country	Name	City	State
Netherlands	ICON	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
ImmunoRx Pharma Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Serious Adverse Events	Evaluation of Safety and Tolerability of IRX-010	Baseline upto Day 168
Primary	Number of participants with Treatment-Emergent Adverse Events	Evaluation of Safety and Tolerability of IRX-010	Baseline upto Day 168
Secondary	Pharmacokinetics(PK): Area under Curve(AUC)	PK: AUC of IRX-010	Baseline upto Day 168
Secondary	Pharmacokinetics(PK): Maximum Concentration (Cmax)	PK: Cmax of IRX-010	Baseline upto Day 168
Secondary	Pharmacokinetics(PK): Half-Life (t½)	PK: t½ of IRX-010	Baseline upto Day 168