The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of KP104 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of KP104 and Part 2, multiple ascending dose (MAD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
CMAX Clinical Research
Adelaide, Australia
Number of participants reporting Treatment Emergent Adverse Events (TEAEs)
An Adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding), symptom, or disease or any worsening of a pre-existing condition temporally associated with the use of a study drug, whether or not related to study drug. A TEAE is defined as any AE that started or worsened in severity on or after the first dose of study treatment.
Time frame: Up to Day 85
Number of participants reporting Treatment Emergent Serious Adverse Events (TESAEs)
A TESAE is defined as any AE that started or worsened in severity on or after the first dose of study treatment.
Time frame: Up to Day 85
Number of participants with Dose-limiting toxicities (DLT)
A DLT is defined as any adverse event considered by the investigator to be KP104-related with a severity greater than or equal to (\>=) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 3 which also represents a shift from baseline clinical status of \> 1 NCI CTCAE grade. A hypersensitivity/administration reaction occurring with a severity of Grade 2 despite the use of pre-medications will also be designated as a DLT.
Time frame: Up to Day 85
Number of participants reporting AEs of Special interests (AESIs)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease or any worsening of a pre-existing condition temporally associated with the use of a study drug, whether or not related to study drug. Number of participants with AESIs including infections and local or systemic administration reactions will be assessed.
Time frame: Up to Day 85
Maximum concentration (Cmax) of KP104
Time frame: Up to Day 29
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Area under the concentration-time profile (AUC) of KP104
Time frame: Up to Day 29
Change from baseline in total and free serum C5 levels
Time frame: Baseline and up to Day 29
Change from baseline in rabbit red blood cell (RBC) assay
Time frame: Baseline and up to Day 29