Skip to main content
OpenTrials
Completed

NCT Number: NCT05490017

To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of KP104

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMAX Clinical Research

Adelaide, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Weight of > 40 kilograms (kg) and < 120 kg at Screening.
  • In good general health, determined by no clinically significant findings in the opinion of the Investigator from medical history, physical examination, 12-lead ECG, clinical laboratory findings, and vital signs at Screening and Check-in.
  • Hemoglobin, hematocrit, white blood cell count, absolute neutrophil count, and platelet count results within the normal range at the Screening Visit; participants with Gilbert's disease with associated abnormalities of liver function tests are eligible for enrollment. Tests may be repeated at the discretion of the Investigator to confirm abnormalities.
  • Creatinine clearance based on the Cockcroft-Gault equation of >= 80 milliliters per minute (ml/min).
  • Females of childbearing potential and males must practice effective contraception from Screening until 28 days after the end of study (EOS) visit.
  • Females of childbearing potential must have a negative pregnancy test at Screening and within 24 hours prior to dosing of study drug; for post-menopausal subjects, a blood sample will also be tested for follicle stimulating hormone to confirm post-menopausal status.

Exclusion criteria

  • Any clinically significant underlying illness in the opinion of the Investigator.
  • Any history or sign of significant chronic active or recurrent infection, or screening laboratory evidence consistent with a significant chronic active or recurrent infection requiring treatment with antibacterials, antivirals, or antifungals.
  • Treatment of any infection with IV (within 30 days of Screening) or oral (within 14 days of Screening) antibacterials, antivirals, or antifungals.
  • History of clinically significant hematologic or bone marrow disease or blood dyscrasias.
  • History of meningococcal infection.
  • History of tuberculosis.
  • History of asplenia (functional or anatomical).
  • Prior exposure to KP104.
  • Known allergy to penicillin antibiotics or history of allergy or contraindication to required prophylactic antibiotic therapy to be used during the study.
  • Known or suspected complement deficiency during screening.
  • Positive serology for Hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) at Screening.
  • History of drug or alcohol abuse within 1 year of Screening in the opinion of the investigator, or a positive test for drugs of abuse or alcohol at Screening or Check-in.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

KP104

Drug

Participants will receive KP104 intravenous (IV) dose approximately for 1 hour or subcutaneous (SC) dose.

Placebo

Drug

Participants will receive matching placebo which is KP104 vehicle containing sodium phosphate, sodium chloride, and L-Lysine Hydrochloride (L-Lys-HCL).

Primary outcomes

  1. Number of participants reporting Treatment Emergent Adverse Events (TEAEs)

    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.

  2. Number of participants reporting Treatment Emergent Serious Adverse Events (TESAEs)

    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.

  3. Number of participants with Dose-limiting toxicities (DLT)

    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.

  4. Number of participants reporting AEs of Special interests (AESIs)

    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.

Secondary outcomes

  1. Maximum concentration (Cmax) of KP104

    Time frame: Up to Day 29

  2. Area under the concentration-time profile (AUC) of KP104

    Time frame: Up to Day 29

  3. Change from baseline in total and free serum C5 levels

    Time frame: Baseline and up to Day 29

  4. Change from baseline in rabbit red blood cell (RBC) assay

    Time frame: Baseline and up to Day 29

Other outcomes

  1. Changes in serum free C5 levels to Minimum concentration (Cmin) correlation

    Time frame: Baseline and up to Day 29

  2. Changes in serum free C5 levels to AUC correlation

    Time frame: Baseline and up to Day 29

  3. Changes in C3b activity to Cmax correlation

    Time frame: Baseline and up to Day 29

  4. Changes in C3b activity to Cmin correlation

    Time frame: Baseline and up to Day 29

  5. Changes in C3b activity to AUC correlation

    Time frame: Baseline and up to Day 29

  6. Changes in rabbit RBC lysis to Cmax correlation

    Time frame: Baseline and up to Day 29

  7. Changes in rabbit RBC lysis to Cmin correlation

    Time frame: Baseline and up to Day 29

  8. Changes in rabbit RBC lysis to AUC correlation

    Time frame: Baseline and up to Day 29

  9. Immunogenicity of KP104

    Time frame: Up to Day 29

  10. Maximum tolerated dose (MTD) of KP104

    Time frame: Up to Day 29

  11. Optimal biologic dose (OBD) of KP104

    Time frame: Up to Day 29

  12. Number of participants with clinically significant changes in laboratory values, electrocardiograms (ECGs), physical examinations, and vital signs

    Time frame: Up to Day 29

  13. Changes in serum free complement component C5 levels to Cmax correlation

    Time frame: Baseline and up to Day 29

  14. Dose optimization of KP104

    Time frame: Up to Day 29

  15. Systemic clearance (Cl) of KP104

    Time frame: Up to Day 29

  16. Elimination half-life (t½) of KP104

    Time frame: Up to Day 29

  17. Change from baseline in complement component of C3b activity assay

    Time frame: Baseline and up to Day 29

  18. Absolute bioavailability of KP104 administered SC (F)

    Time frame: Up to Day 29

  19. Change from baseline in Factor H (FH) serum levels

    Time frame: Baseline and up to Day 29

Sponsors and collaborators

Lead sponsor

Kira Pharmacenticals (US), LLC.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 5, 2022
Registry last updated
Mar 1, 2023

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.

Published trials that share one or more normalized conditions with this study.