First-In-Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Escalating Single And Multiple Doses Of CSL040 In Healthy Subjects

• Status: Recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

First-In-Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Escalating Single And Multiple Doses Of CSL040 In Healthy Subjects

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: CSL Behring

Criteria

Inclusion Criteria:

1. Male or female 18 to 64 years of age, inclusive, at Screening

2. Body weight in the range of ≥ 50 kg and ≤ 100 kg, with a body mass index of ≥ 18 kg/m2 and ≤ 30 kg/m2, at Screening

3. Judged as healthy by an Investigator after completion of a comprehensive clinical assessment

4. Capable of providing written informed consent and willing and able to adhere to all protocol requirements

5. Can understand the nature, scope, and possible consequences of the study and able to comply with study procedures, restrictions, and requirements

6. Able to provide proof of vaccination against meningococcal disease according to local requirements or willing to receive meningococcal vaccination aligned with local guidelines (vaccination with recombinant meningococcal B vaccine against B serogroup [Men B] and quadrivalent meningococcal conjugate vaccine against A, C, W, and Y serogroups [Men ACWY]), at least 21 days before the first dose of CSL040

7. Continuous nonsmoker who has not used nicotine- and tobacco-containing products for at least 30 days prior to the first dosing based on urine cotinine testing at Screening and Day-1

Exclusion Criteria:

1. Any individual at high risk of exposure to Neisseria meningitidis, including, but not limited to, health care workers, doctors, nurses, students working in a clinical setting, laboratory workers with exposure to N. meningitidis, individuals residing in a dormitory setting (eg, military workers), and childcare workers

2. Other than the required meningococcal vaccines, any live vaccinations within the last 90 days before and during the study and / or up to 90 days after the last administration of the investigational product

3. A positive test result for hepatitis B surface antigen (HBsAg), hepatitis B core antigen, hepatitis B surface antibody, hepatitis C virus antibody, or human immunodeficiency virus-1/2 antibody.

4. History concerning for a N. meningitidis infection

5. History of allergy or intolerance to Penicillin V

6. History of unexplained, recurrent infection, life-threatening infection, or history that suggests any immunodeficiency (functional immunodeficiency), including asplenia / functional asplenia

7. Infection requiring treatment with systemic antibiotics (IV and / or oral administration for more than 3 days) within the last 90 days prior to dosing

8. Clinical evidence of current active serious infection, including any localized infections, or any infection which makes the participation in this study of healthy subjects unacceptably high risk

9. Blood pressure or pulse rate measurements outside the normal range for the subject's age and assessed as clinically significant

10. Known history of severe hypersensitivity reactions or suspected hypersensitivity to the CSL040 or any of the excipients or other monoclonal antibodies

11. Subject has any condition that may compromise their safety or compliance, impede successful conduct of the study, interfere with interpretation of the results or would otherwise render the subject unsuitable for participation in the study

12. A positive test result for drugs of abuse (including alcohol) at Screening and / or Day -1.

13. Weekly alcohol intake of > 10 units for females and > 14 units for males during the 3 months before Day -1.

14. Any values above the upper limit of normal (ULN) for alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST), or bilirubin test result

15. Use of prescription or over-the-counter medication, herbal and dietary supplements, and vitamins and minerals (except the vaccination as required per protocol) within the 21 days before administration of investigational product

16. Female subject of childbearing potential or fertile male subject who are neither using nor willing to use a highly effective method of contraception

17. Pregnant, lactating, or breastfeeding

18. Donation or loss of more than 500 mL of blood within 3 months, or donated plasma within 7 days, before admission to the unit and for 5 half-lives or until the end of the study, whichever is longer

19. Any planned surgical procedures during the study period

20. Participation in any other investigational product study in which receipt of an investigational product occurred within 5 half-lives or 28 days (whichever is longer) before dosing of investigational product, or participation in more than 4 clinical studies involving administration of an investigational product within the last 12 months before Screening

21. Subject who met all eligibility criteria but was not needed (ie, alternate subjects). Alternate subjects are eligible to participate in subsequent cohorts.