Healthy VolunteersPhase 1NCT05965089
A First in Human Study of AX-202 in Healthy Subjects and Patients With Psoriasis.
A Phase 1 study testing AX-202 in people with Healthy Volunteers and Mild to Moderate Psoriasis, run by Arxx Therapeutics at 1 site in United Kingdom.
Trial summary
The first-in-human study will be performed in healthy volunteers and patients with a chronic inflammatory skin disease. The primary objective is to evaluate the safety, tolerability and pharmacokinetics of increasing doses of AX-202 infusion. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Mild to Moderate Psoriasis
- What is being tested?
- AX-202
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Apr 2023to 31 Jul 2024
- 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
- Part A / Single ascending doses:
- Male and female subjects must be between 18-55 years inclusive, at the time of informed consent.
- Subjects must have a Body Mass Index (BMI) ≥ 18 and ≤ 32 kg/m2 and weight of at least 45kg at screening.
- Subjects must be in good health as determined by medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory assessments at the time of screening, as judged by the Investigator.
- Part B / Multiple ascending doses:
- Male and female patients must be between 18-65 years inclusive, at the time of informed consent.
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- Patients must have a documented diagnosis of plaque psoriasis for ≥ 6 months prior to screening.
- Patients must have a Body Mass Index (BMI) ≥ 18 and ≤ 36 kg/m2 and weigh at least 45kg at screening.
- Patients must be in good health as determined by medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory assessments at the time of screening, as judged by the Investigator.
Who cannot join
- Part A / Single ascending doses:
- History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the subject's safety during the clinical study or expose the subject to undue risk as judged by the Investigator.
- After a minimum of 10 minutes supine rest at the time of screening or on Day -1:
- Systolic blood pressure <90 or >140 mmHg, or
- Diastolic blood pressure <50 or >90 mmHg, or
- Pulse <40 or >90 bpm
Show all 59Show fewer
- Any clinically significant abnormalities in resting ECG at the time of screening or on Day -1 including prolonged QTcF (>450 ms for males; >470 ms for females using the mean of triplicate ECGs) and cardiac arrhythmias, as judged by the Investigator.
- Clinically significant abnormalities in renal function at screening.
- Clinically significant abnormalities in liver function at screening.
- Haemoglobin < 130 g/l for males or <120 g/l for females at screening.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP (Day 1).
- Malignancy within the past 5 years of screening with the exception of in situ removal of basal cell carcinoma or resected benign colonic polyps.
- Any planned major surgery within the duration of the study or in the 30 days following study completion.
- History of latent or active tuberculosis or a positive QuantiFERON® TB Gold test at screening.
- Females who are pregnant, breast feeding, lactating or plan to be pregnant during the study period or 120 days after.
- Female subjects with a positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) at screening or on Day -1.
- Positive serum hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus (HIV) 1 and/or 2 antibodies at screening.
- A Positive test for active COVID -19 prior to dosing on Day 1.
- History of any drug and/or alcohol abuse in the past 2 years prior to screening.
- Regular alcohol consumption of >14 units per week.
- Positive urine drugs of abuse test and/or alcohol breath test at screening or on admission to the unit on Day -1 that cannot be accounted for by concomitant medication in the opinion of the Investigator.
- Current or previous use of tobacco, nicotine products or e-cigarettes in the past 6 months.
- Smoking history of > 5 pack years.
- Positive urine cotinine test at screening or Day -1.
- Receiving any of the prohibited concomitant medications as specified in Section 5.5.3.1.
- Known history of intolerance or hypersensitivity to AX-202 or to any other component of the formulation.
- Known history of intolerance to placebo or excipients.
- Participation in another clinical study with an experimental drug within 3 months (non-biologic), 6 months (biologic) or 5 half-lives, whichever is longer, before the administration of IMP.
- Part B / Multiple ascending doses:
- History or presence of any clinically relevant acute or chronic medical or psychiatric condition other than psoriasis that could interfere with the patient's safety during the clinical study or expose the patient to undue risk as judged by the Investigator.
- A diagnosis of non-plaque psoriasis.
- Plaque psoriasis restricted to the scalp, palms, soles and face.
- Pustular, erythrodermic, inverse, and guttate psoriasis
- Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium)
- Diagnosis of psoriatic arthritis, uveitis, inflammatory bowel disease, or other immune-mediated conditions that are commonly associated with psoriasis for which a patient requires current systemic (oral, subcutaneous [SC], or IV) (including corticosteroids, immunosuppressants, biologics) immunosuppressant medical treatment.
- Presence of other skin conditions that could interfere with psoriasis evaluation or assessments as judged by the Investigator.
- After a minimum of 10 minutes supine rest at the time of screening or on Day -1:
- Systolic blood pressure <90 or >140 mmHg, or
- Diastolic blood pressure <50 or >90 mmHg, or
- Pulse <40 or >90 bpm 9. Any clinically significant abnormalities in resting ECG at the time of screening or on Day -1 including prolonged QTcF (>450 ms for males; >470 ms for females using the mean of triplicate ECG's) and cardiac arrhythmias, as judged by the Investigator.
- Clinically significant abnormalities in renal function at screening.
- Clinically significant abnormalities in liver function at screening.
- Haemoglobin <130 g/l for males or <120 g/l for females at screening.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP (Day 1).
- Malignancy within the past 5 years of screening with the exception of in-situ removal of basal cell carcinoma or resected benign colonic polyps.
- Any planned major surgery within the duration of the study or in the 30 days following study completion.
- History of latent or active tuberculosis, or a positive QuantiFERON® TB Gold result at screening.
- Females who are pregnant, breast feeding, lactating or plan to be pregnant during the study period or 120 days after.
- Female patients with a positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) at screening or on Day -1.
- Positive serum hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus (HIV) 1 and/or 2 antibodies at screening.
- A Positive test for active COVID -19 prior to dosing on Day 1.
- History of any drug and/or alcohol abuse in the past 2 years prior to screening.
- Regular alcohol consumption of >14 units per week.
- Positive urine drugs of abuse test and/or alcohol breath test at screening or on admission to the unit on Day -1 that cannot be accounted for by concomitant medication in the opinion of the Investigator.
- Receiving any of the prohibited concomitant medications as specified in Section 5.5.3.2.
- Any clinically significant infection requiring antimicrobial treatment in the 2 weeks prior to Day 1.
- Known history of intolerance or hypersensitivity to AX-202 or to any other component of the formulation.
- Known history of intolerance to placebo or excipients.
- Participation in another clinical study with an experimental drug within 3 months (non-biologic), 6 months (biologic) or 5 half-lives, whichever is longer, before the administration of IMP.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Medicines Evaluation Unit
Manchester, Wythenshawe, M23 9QZ
About this study
Official title: A First-in-human, Randomised Double-blind, Placebo-controlled 2-part Study to Evaluate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Single Ascending Doses of AX-202 in Healthy Subjects and Multiple Ascending Doses of AX-202 in Patients With Mild to Moderate Chronic Plaque Psoriasis.
The first-in-human study will be performed in healthy volunteers and patients with a chronic inflammatory skin disease. The primary objective is to evaluate the safety, tolerability and pharmacokinetics of increasing doses of AX-202 infusion.
- Conditions
- Healthy Volunteers, Mild to Moderate Psoriasis
- Being tested
- Placebo, AX-202
- Keywords
- Single Ascending Doses, Multiple Ascending Doses, AX-202
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
Placebo
AX-202Biological
Humanized monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| AX-202 | Experimental | Single and multiple ascending doses of AX-202 Receives: Biological: AX-202 |
| Placebo | Placebo comparator | Single and multiple doses of placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by monitoring of adverse events.
Number of patients with AE's
Measured: Until 100 days after last dose
To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by physical examinations.
Number of patients with clinically significant findings on physical examinations
Measured: Until 100 days after last dose
To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by assessment of infusion related reactions
Number of patients with infusion related reactions
Measured: Until 100 days after last dose
To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by monitoring of vital signs
Number of patients with clinically significant changes from baseline in vital signs
Measured: Until 100 days after last dose
To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by monitoring of clinical laboratory parameters
Number of patients with clinically significant change from baseline in clinical laboratory test results.
Measured: Until 100 days after last dose
To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by ECG monitoring
Number of patients with clinically significant change from baseline in ECG parameters
Measured: Until 100 days after last dose
Secondary outcomes (7)
To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
Calculation of maximum serum concentration (Cmax) of AX-202
Measured: Until 100 days after last dose
To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
Calculation of time to maximum concentration (tmax) of AX-202
Measured: Until 100 days after last dose
To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
Calculation of the area under the plasma concentration-time curve (AUC)
Measured: Until 100 days after last dose
To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
Calculation of the half-life of AX-202
Measured: Until 100 days after last dose
To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
Calculation of the clearance (CL) of AX-202
Measured: Until 100 days after last dose
To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
Calculation of volume of distribution at steady state (Vss)
Measured: Until 100 days after last dose
To evaluate immunogenicity of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
Number of participants with anti-drug antibodies against AX-202
Measured: Until 100 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start25 Apr 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-ascending doses in healthy subjects and multiple ascending doses in patients with mild to moderate chronic plaque psoriasis
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arxx Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965089
- Sponsor's protocol ID
- AX-202-01
- Status last verified
- Oct 2026
- First submitted
- 27 Jun 2023
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated and/or analysed during the current study will be available upon request from Arxx Therapeutics, contact details can be found at the following website: https://arxxtx.com/. Deidentified individual participant data will be available after the study has been reported, approximately 12 months after the study's concluded. These data will be available for 36 months. These data will be shared with Investigators whose proposed use of the data has been approved by Arxx Therapeutics. Proposals may be submitted up to 36 months following reporting of the study.
Publications
Hallen J, Vetrhus S, Sorgaard M, Klingelhofer J, Borchert S, Holyer I, Ramesh S, Distler JHW, Singh D. A first-in-human study of CAL101, a monoclonal antibody targeting S100A4. Br J Clin Pharmacol. 2026 Sep 1. doi: 10.1002/bcp.70808. Online ahead of print.
PubMed 42677494Borchert SV, Hallen J, Hussain RI, Holyer I, Troelsen JT, Klingelhofer J. Development of CAL101-a humanized monoclonal antibody targeting S100A4 to inhibit proinflammatory and profibrotic signaling. J Pharmacol Exp Ther. 2025 Nov;392(11):103722. doi: 10.1016/j.jpet.2025.103722. Epub 2025 Sep 24.
PubMed 41124966
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Randomised Double-blind, Placebo-controlled 2-part Study to Evaluate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Single Ascending Doses of AX-202 in Healthy Subjects and Multiple Ascending Doses of AX-202 in Patients With Mild to Moderate Chronic Plaque Psoriasis.
- ClinicalTrials.gov ID
- NCT05965089
- Acronym / sponsor ID
- AX-202-01
- Conditions
- Healthy Volunteers, Mild to Moderate Psoriasis
- Keywords
- Single Ascending Doses, Multiple Ascending Doses, AX-202
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Arxx TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 28 Jul 2023 (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 first-in-human study will be performed in healthy volunteers and patients with a chronic inflammatory skin disease. The primary objective is to evaluate the safety, tolerability and pharmacokinetics of increasing doses of AX-202 infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-ascending doses in healthy subjects and multiple ascending doses in patients with mild to moderate chronic plaque psoriasis
| Arm | Type | Receives |
|---|---|---|
| AX-202 | Experimental | Biological: AX-202Single and multiple ascending doses of AX-202 |
| Placebo | Placebo comparator | Biological: PlaceboSingle and multiple doses of placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female subjects must be between 18-55 years inclusive, at the time of informed consent.
- Subjects must have a Body Mass Index (BMI) ≥ 18 and ≤ 32 kg/m2 and weight of at least 45kg at screening.
- Subjects must be in good health as determined by medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory assessments at the time of screening, as judged by the Investigator.
- Male and female patients must be between 18-65 years inclusive, at the time of informed consent.
- Patients must have a documented diagnosis of plaque psoriasis for ≥ 6 months prior to screening.
Key exclusion criteria (59 listed)
- History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the subject's safety during the clinical study or expose the subject to undue risk as judged by the Investigator.
- After a minimum of 10 minutes supine rest at the time of screening or on Day -1:
- Any clinically significant abnormalities in resting ECG at the time of screening or on Day -1 including prolonged QTcF (>450 ms for males; >470 ms for females using the mean of triplicate ECGs) and cardiac arrhythmias, as judged by the Investigator.
- Clinically significant abnormalities in renal function at screening.
- Clinically significant abnormalities in liver function at screening.
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 |
|---|---|---|
| PlaceboPlacebo | Biological | Placebo |
| AX-202Humanized monoclonal antibody | Biological | AX-202 |
Primary outcome
To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by monitoring of adverse events.
Time frame: Until 100 days after last dose
Number of patients with AE's
To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by physical examinations.
Time frame: Until 100 days after last dose
Number of patients with clinically significant findings on physical examinations
To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by assessment of infusion related reactions
Time frame: Until 100 days after last dose
Number of patients with infusion related reactions
To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by monitoring of vital signs
Time frame: Until 100 days after last dose
Number of patients with clinically significant changes from baseline in vital signs
To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by monitoring of clinical laboratory parameters
Time frame: Until 100 days after last dose
Number of patients with clinically significant change from baseline in clinical laboratory test results.
To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by ECG monitoring
Time frame: Until 100 days after last dose
Number of patients with clinically significant change from baseline in ECG parameters
7 secondary outcomes
To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
Time frame: Until 100 days after last dose
To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
Time frame: Until 100 days after last dose
To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
Time frame: Until 100 days after last dose
To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
Time frame: Until 100 days after last dose
To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
Time frame: Until 100 days after last dose
To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
Time frame: Until 100 days after last dose
To evaluate immunogenicity of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
Time frame: Until 100 days after last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Results publication: PubMed 42677494Hallen J, Vetrhus S, Sorgaard M, Klingelhofer J, Borchert S, Holyer I, Ramesh S, Distler JHW, Singh D. A first-in-human study of CAL101, a monoclonal antibody targeting S100A4. Br J Clin Pharmacol. 2026 Sep 1. doi: 10.1002/bcp.70808. Online ahead of print.
- Derived from this study: PubMed 41124966Borchert SV, Hallen J, Hussain RI, Holyer I, Troelsen JT, Klingelhofer J. Development of CAL101-a humanized monoclonal antibody targeting S100A4 to inhibit proinflammatory and profibrotic signaling. J Pharmacol Exp Ther. 2025 Nov;392(11):103722. doi: 10.1016/j.jpet.2025.103722. Epub 2025 Sep 24.
- Individual participant dataSharing planned: Yes. The datasets generated and/or analysed during the current study will be available upon request from Arxx Therapeutics, contact details can be found at the following website: https://arxxtx.com/. Deidentified individual participant data will be available after the study has been reported, approximately 12 months after the study's concluded. These data will be available for 36 months. These data will be shared with Investigators whose proposed use of the data has been approved by Arxx Therapeutics. Proposals may be submitted up to 36 months following reporting of the study.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 AX-202 in people with Healthy Volunteers and Mild to Moderate Psoriasis, run by Arxx Therapeutics at 1 site in United Kingdom.
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 9 inclusion and 59 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: finished, as of the sponsor's last update on 2 Nov 2026. 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 United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by monitoring of adverse events. (time frame: Until 100 days after last dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05965089, which also lists 2 linked publications.
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 2 Nov 2026.