CMAX Clinical Research
Adelaide, Australia
NCT Number: NCT05490017
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).
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Adelaide, Australia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Participants will receive KP104 intravenous (IV) dose approximately for 1 hour or subcutaneous (SC) dose.
Participants will receive matching placebo which is KP104 vehicle containing sodium phosphate, sodium chloride, and L-Lysine Hydrochloride (L-Lys-HCL).
Time frame: Up to Day 85
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
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
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
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 29
Time frame: Up to Day 29
Time frame: Baseline and up to Day 29
Time frame: Baseline and up to Day 29
Time frame: Baseline and up to Day 29
Time frame: Baseline and up to Day 29
Time frame: Baseline and up to Day 29
Time frame: Baseline and up to Day 29
Time frame: Baseline and up to Day 29
Time frame: Baseline and up to Day 29
Time frame: Baseline and up to Day 29
Time frame: Baseline and up to Day 29
Time frame: Up to Day 29
Time frame: Up to Day 29
Time frame: Up to Day 29
Time frame: Up to Day 29
Time frame: Baseline and up to Day 29
Time frame: Up to Day 29
Time frame: Up to Day 29
Time frame: Up to Day 29
Time frame: Baseline and up to Day 29
Time frame: Up to Day 29
Time frame: Baseline and up to Day 29
Kira Pharmacenticals (US), LLC.
Industry
SYNERGY-1: A Phase 1 First-in-human, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of KP104 in Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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