Phase 1 study in 2 stages with 2 expansion cohorts. The first stage is a single ascending dose (SAD) study of APVO210 in healthy volunteers. The second stage is a multiple ascending dose (MAD) study of APVO210 in healthy volunteers. Two expansion cohorts evaluate multiple doses of APVO210 in psoriasis patients and ulcerative colitis patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
85
Nucleus Network
Melbourne, Victoria, Australia
Number of subjects with adverse events
Time frame: up to Day 29
Number of subjects with clinically relevant findings in vital signs
Time frame: up to Day 29
Number of subjects with significant changes from baseline laboratory measurements
Time frame: up to Day 29
Number of subjects with clinically significant abnormalities in electrocardiogram (ECG) results
Time frame: up to Day 29
Number of subjects with clinical significant abnormalities found on physical examination
Time frame: up to Day 29
Number of subjects with adverse events
Time frame: up to Day 57
Number of subjects with clinically relevant findings in vital signs
Time frame: up to Day 57
Number of subjects with significant changes from baseline laboratory measurements
Time frame: up to Day 57
Number of subjects with clinically significant abnormalities in electrocardiogram (ECG) results
Time frame: up to Day 57
Number of subjects with clinical significant abnormalities found on physical examination
Time frame: up to Day 57
Number of psoriasis patients with adverse events
Time frame: up to day 141
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Number of psoriasis patients with clinically relevant findings in vital signs
Time frame: up to day 141
Number of psoriasis patients with significant changes from baseline laboratory measurements
Time frame: up to day 141
Number of psoriasis patients with clinically significant abnormalities in electrocardiogram (ECG) results
Time frame: up to day 141
Number of psoriasis patients with clinical significant abnormalities found on physical examination
Time frame: up to day 141
Number of ulcerative colitis patients with adverse events
Time frame: up to day 141
Number of ulcerative colitis patients with clinically relevant findings in vital signs
Time frame: up to day 141
Number of ulcerative colitis patients with significant changes from baseline laboratory measurements
Time frame: up to day 141
Number of ulcerative colitis patients with clinically significant abnormalities in electrocardiogram (ECG) results
Time frame: up to day 141
Number of ulcerative colitis patients with clinical significant abnormalities found on physical examination
Time frame: up to day 141
The number of subjects who develop anti-drug antibodies to APVO210
Time frame: Up to day 29
The number of subjects who develop anti-drug antibodies to APVO210
Time frame: Up to day 57
The number of psoriasis patients who develop anti-drug antibodies to APVO210
Time frame: Up to day 141
The number of ulcerative colitis patients who develop anti-drug antibodies to APVO210
Time frame: Up to day 141
Serum level of Peak Plasma Concentration (Cmax)
Time frame: Up to day 29
Serum level of Peak Plasma Concentration (Cmax)
Time frame: Up to day 57
Serum level of Peak Plasma Concentration (Cmax) in psoriasis patients
Time frame: Up to day 141
Serum level of Peak Plasma Concentration (Cmax) in ulcerative colitis patients
Time frame: Up to day 141
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to day 29
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to day 57
Area under the plasma concentration versus time curve (AUC) for psoriasis patients
Time frame: Up to day 141
Area under the plasma concentration versus time curve (AUC) for ulcerative colitis patients
Time frame: Up to day 141
Change in number of leukocytes by flow cytometry in psoriasis patients
Time frame: Up to day 141
Change in number of leukocytes by flow cytometry in ulcerative colitis patients
Time frame: Up to day 141
Change in cytokine levels by ex-vivo LPS stimulation assay in psoriasis patients.
Time frame: Up to day 141
Change in cytokine levels by ex-vivo LPS stimulation assay in ulcerative colitis patients.
Time frame: Up to day 141