The purpose of the study is to investigate the safety, tolerability, and pharmacokinetic parameters of 2 dose strengths of donzakimig, each administered subcutaneously as a single dose, in healthy Chinese and Japanese study participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
32
Drug: Donzakimig Pharmaceutical form: Subcutaneous solution
Drug: Placebo Pharmaceutical form: Subcutaneous solution
UP0142 1
Anaheim, California, United States
Occurrence of treatment-emergent adverse events (TEAEs)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment emergent adverse events (TEAEs) are adverse events not present prior to the pharmaceutical product administration or an already present event that worsens either in intensity or frequency
Time frame: From Baseline to End of Study visit (up to Day 57)
Occurrence of serious treatment-emergent adverse events (serious TEAEs)
A serious treatment-emergent adverse event (serious TEAE) is defined as any untoward medical occurrence that, at any dose: Results in death Is life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent disability/incapacity Is a congenital anomaly/birth defect Important medical events
Time frame: From Baseline to End of Study visit (up to Day 57)
Maximum plasma concentration (Cmax) of donzakimig
Cmax: Maximum plasma concentration of donzakimig
Time frame: Sampling timepoints will be on Day 1 (D1): at predose and 6 hours (h), 24h (D2), 72h (D4), 120h (D6), D8, D15, D22, D36, and D57 after investigational medicinal product (IMP) administration.
Area under the plasma concentration-time curve from time 0 to t of donzakimig
AUC0-t: Area under the plasma concentration-time curve from from 0 to the time (t) of the last quantifiable concentration.
Time frame: Sampling timepoints will be on Day 1 (D1): at predose and 6 hours (h), 24h (D2), 72h (D4), 120h (D6), D8, D15, D22, D36, and D57 after investigational medicinal product (IMP) administration.
Area under the plasma concentration-time curve from zero to infinity of donzakimig
AUC: Area under the plasma concentration-time curve from zero to infinity of donzakimig
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Sampling timepoints will be on Day 1 (D1): at predose and 6 hours (h), 24h (D2), 72h (D4), 120h (D6), D8, D15, D22, D36, and D57 after investigational medicinal product (IMP) administration.