A First in Human Study of AX-202 in Healthy Subjects and Patients With Psoriasis.

NCT05965089 | Completed Phase 1 DMC

• 1 other identifier: AX-202-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers; Mild to Moderate Psoriasis

Keywords

Single Ascending Doses; Multiple Ascending Doses; AX-202

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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

  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

  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.

  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

  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.

  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.

  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.

  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.

  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.

  Until 100 days after last dose

Study Arms (2)

AX-202

EXPERIMENTAL

Single and multiple ascending doses of AX-202

Biological: AX-202

Placebo

PLACEBO COMPARATOR

Single and multiple doses of placebo

Biological: Placebo

Interventions

Placebo BIOLOGICAL

Placebo

Placebo

AX-202 BIOLOGICAL

Humanized monoclonal antibody

AX-202

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Arxx Therapeutics: lead

Study Sites (1)

Medicines Evaluation Unit

Manchester, Wythenshawe, M23 9QZ, United Kingdom

Location

Related Publications (1)

• Borchert 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.

  PMID: 41124966 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-ascending doses in healthy subjects and multiple ascending doses in patients with mild to moderate chronic plaque psoriasis

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 28, 2023
• Study Start: April 25, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Deidentified data will be available approximately 12 months after the study's concluded. These data will be available for 36 months. Proposals for use of data may be submitted up to 36 months following reporting of the study.
• Access Criteria: Data will be shared with Investigators whose proposed use of the data has been approved by Arxx Therapeutics.

Locations

GB (1)