Healthy ParticipantsPhase 1NCT06356259
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Intravenous Administration of IRX-010 in Healthy Participants
A Phase 1 study testing IRX-010 in people with Healthy Participants, run by ImmunoRx Pharma Inc. at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- IRX-010
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Jun 2023to 23 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics with intravenous(IV) administration of IRX-010 in Healthy Participants.
Read the 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.
- Conditions
- Healthy Participants
- Being tested
- IRX-010, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRX-010Drug
Administered IV
PlaceboDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| IRX-010 Part A (SAD) | Experimental | A single dose of IRX-010 will be administered intravenously Receives: Drug: IRX-010 |
| Placebo Part A (SAD) | Placebo comparator | Placebo administered intravenously Receives: Drug: Placebo |
| IRX-010 Part B(MAD) | Experimental | Multiple doses of IRX-010 will be administered intravenously Receives: Drug: IRX-010 |
| Placebo Part B(MAD) | Placebo comparator | Placebo administered intravenously Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Serious Adverse Events
Evaluation of Safety and Tolerability of IRX-010
Measured: Baseline upto Day 168
Number of participants with Treatment-Emergent Adverse Events
Evaluation of Safety and Tolerability of IRX-010
Measured: Baseline upto Day 168
Secondary outcomes (3)
Pharmacokinetics(PK): Area under Curve(AUC)
PK: AUC of IRX-010
Measured: Baseline upto Day 168
Pharmacokinetics(PK): Maximum Concentration (Cmax)
PK: Cmax of IRX-010
Measured: Baseline upto Day 168
Pharmacokinetics(PK): Half-Life (t½)
PK: t½ of IRX-010
Measured: Baseline upto Day 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start7 Jun 2023
- Primary completion23 Jan 2025
- Study completion23 Jan 2025
Why it stopped: The highest multiple dose planned for this study was not well tolerated by most participants. There is no benefit to continue dosing of healthy participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunoRx Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ImmunoRx Pharma,Inc, Study director, ImmunoRx Pharma Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356259
- Sponsor's protocol ID
- IMMUNRX-01
- Other IDs
- 2023-503917-31, 2023
- Status last verified
- Mar 2025
- First submitted
- 4 Apr 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06356259
- Acronym / sponsor ID
- IMMUNRX-01
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The highest multiple dose planned for this study was not well tolerated by most participants. There is no benefit to continue dosing of healthy participants.
- Enrolment
- 83 participants (actual)
- Lead sponsor
- ImmunoRx Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IRX-010 Part A (SAD) | Experimental | Drug: IRX-010A single dose of IRX-010 will be administered intravenously |
| Placebo Part A (SAD) | Placebo comparator | Drug: PlaceboPlacebo administered intravenously |
| IRX-010 Part B(MAD) | Experimental | Drug: IRX-010Multiple doses of IRX-010 will be administered intravenously |
| Placebo Part B(MAD) | Placebo comparator | Drug: PlaceboPlacebo administered intravenously |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRX-010Administered IV | Drug | IRX-010 Part A (SAD), IRX-010 Part B(MAD) |
| PlaceboAdministered IV | Drug | Placebo Part A (SAD), Placebo Part B(MAD) |
Primary outcome
Number of participants with Serious Adverse Events
Time frame: Baseline upto Day 168
Evaluation of Safety and Tolerability of IRX-010
Number of participants with Treatment-Emergent Adverse Events
Time frame: Baseline upto Day 168
Evaluation of Safety and Tolerability of IRX-010
3 secondary outcomes
Pharmacokinetics(PK): Area under Curve(AUC)
Time frame: Baseline upto Day 168
Pharmacokinetics(PK): Maximum Concentration (Cmax)
Time frame: Baseline upto Day 168
Pharmacokinetics(PK): Half-Life (t½)
Time frame: Baseline upto Day 168
Results and safety
The study was stopped early (reason given: The highest multiple dose planned for this study was not well tolerated by most participants. There is no benefit to continue dosing of healthy participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ImmunoRx Pharma,Inc study director
ImmunoRx Pharma Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IRX-010 in people with Healthy Participants, run by ImmunoRx Pharma Inc. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The highest multiple dose planned for this study was not well tolerated by most participants. There is no benefit to continue dosing of healthy participants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Serious Adverse Events (time frame: Baseline upto Day 168). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.