NCT05937581CompletedPhase 1
A Phase 1, Double-Blind (Sponsor-Unblinded), Placebo-Controlled, Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single And Multiple Doses Of CSL040 In Healthy Adult Subjects
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- CSL Behring
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Number of participants with treatment emergent adverse events (TEAEs), adverse events of special interests (AESIs), and serious adverse events (SAEs)
Study Overview
Brief Summary
First-In-Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Escalating Single And Multiple Doses Of CSL040 In Healthy Subjects
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •1.Male or female 18 to 64 years of age, inclusive, at Screening
- •2.Body weight in the range of greater than or equal to (≥) 50 kg and less than or equal to (≤) 100 kilogram (kg) , with a body mass index of ≥ 18 kilogram per meter square (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 adequate vaccination (as determined by the Investigator) against meningococcal disease, including vaccination against meningococcal serogroup B and meningococcal serogroups A, C, W, and Y OR be willing to receive additional vaccinations against these serogroups per the Australian Immunisation Handbook
- •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
- •8.Able to provide proof of adequate vaccination (as determined by the Investigator) against Haemophilus influenzae type b, Pneumococcus OR be willing to receive additional vaccinations against these pathogens with the first dose at least 21 days before the first dose of CSL040
- •9.Able to provide proof of adequate vaccination (as determined by the Investigator) against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS_CoV-2) OR be willing to receive additional vaccination(s) to achieve adequate vaccination status at least 14 days before the first dose of CSL
- •If there is proof of a recent SARS-CoV-2 infection (as determined by the Investigator) within 90 days of the first dose of CSL040, the requirement for a vaccination will follow the current local clinical practice
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. Vaccination with any live replication-competent vaccine 90 days before Day 1 or planned vaccination with the same within 90 days after the last administration of CSL040
- •3.A positive test result for any of the following: hepatitis B screening, 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, as well as to potential backup medications including azithromycin, ciprofloxacin, and ceftriaxone
- •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 infection, or any infection which makes participation in this study 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 CSL040 or any excipients including polysorbate 80, monoclonal antibodies, or any documented history of a severe allergic reaction (in the opinion of the Investigator), angioedema, or anaphylaxis to food or any other drugs.
- •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) and cotinine at Screening and / or Day -
- •13.Weekly alcohol intake of > 10 units for females and > 14 units for males during the 3 months before Day -
- •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 any vaccinations or other medications required/permitted as per protocol) within the 21 days before first 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 milliLiter (mL) of blood within 3 months, or donation of plasma within 7 days, before admission to the unit or plans to donate blood or plasma and for 5 half-lives of the last dose of CSL040 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
- •22. Prior dosing with CSL040
Arms & Interventions
Part A [Single ascending dose (SAD)]: CSL040 (minimum dose)
Experimental
Single Intravenous (IV) Administration
Intervention: CSL040 (Drug)
Part A (SAD): CSL040 (lower dose)
Experimental
Single IV Administration
Intervention: CSL040 (Drug)
Part A (SAD): CSL040 (low dose)
Experimental
Single IV Administration
Intervention: CSL040 (Drug)
Part A (SAD): CSL040 (medium dose)
Experimental
Single IV Administration
Intervention: CSL040 (Drug)
Part A (SAD): CSL040 (medium-high dose)
Experimental
Single IV Administration
Intervention: CSL040 (Drug)
Part A (SAD): CSL040 (maximum dose)
Experimental
Single IV Administration
Intervention: CSL040 (Drug)
Part A (SAD): Placebo
Placebo Comparator
Single IV Administration
Intervention: Placebo (Drug)
Part B [Multiple ascending dose (MAD)]: CSL040 (minimum dose)
Experimental
IV Administration not to exceed 5 doses over 14 days
Intervention: CSL040 (Drug)
Part B (MAD): CSL040 (medium dose)
Experimental
IV Administration not to exceed 5 doses over 14 days
Intervention: CSL040 (Drug)
Part B (MAD): CSL040 (high dose)
Experimental
IV Administration not to exceed 5 doses over 14 days
Intervention: CSL040 (Drug)
Part B (MAD): Placebo
Placebo Comparator
IV Administration not to exceed 5 doses over 14 days
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of participants with treatment emergent adverse events (TEAEs), adverse events of special interests (AESIs), and serious adverse events (SAEs)
Time Frame: Part A (SAD): Up to 105 days; Part B (MAD): Up to 174 days
Percentages of participants with TEAEs, AESIs, and SAEs
Time Frame: Part A (SAD): Up to 105 days; Part B (MAD): Up to 174 days
The Number of Clinically Significant Changes from Baseline in Clinical Laboratory Tests Reported as AE
Time Frame: Baseline and up to 69 days
Clinical laboratory tests include hematology, biochemistry, coagulation, and urinalysis collected during the study. The investigator determines if the changes in laboratory test results are clinically significant.
Number of participants with vital signs out of normal range
Time Frame: Baseline and up to 69 days
Blood pressure (systolic and diastolic), pulse rate, respiratory rate and tympanic temperature will be assessed.
Change from Baseline in corrected QT interval using Fridericia's formula (QTcF) values of triplicate electrocardiograms
Time Frame: Baseline and up to 69 days
Absolute values of QTcF on electrocardiograms
Time Frame: Baseline and up to 69 days
Number of participants with abnormal electrocardiogram findings
Time Frame: Baseline and up to 69 days
Secondary Outcomes
- Part A (SAD): Maximum concentration (Cmax)(Up to 56 days)
- Part A (SAD): Time to reach maximum concentration (Tmax)(Up to 56 days)
- Part A (SAD): Time to Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last)(Up to 56 days)
- Part A (SAD): Area under the concentration-time curve from time 0 to infinity (AUC0-infinity)(Up to 56 days)
- Part A (SAD): Total systemic clearance (CL)(Up to 56 days)
- Part A (SAD): Volume of distribution (V)(Up to 56 days)
- Part A (SAD): Terminal elimination half-life (T1/2)(Up to 56 days)
- Part B (MAD): Maximum concentration (Cmax)(Up to 69 days)
- Part B (MAD): Time to reach maximum concentration (Tmax)(Up to 69 days)
- Part B (MAD): Time to Area under the concentration-time curve in 1 dosing interval (AUCtau)(Up to 69 days)
- Part B (MAD): Accumulation index (accumulation ratio determined by the ratio of steady state AUCtau to single dose AUCtau)(Up to 69 days)
- Part B (MAD): Lowest concentration prior to dosing (Ctrough)(Up to 69 days)
- Part B (MAD): Total systemic clearance (CL)(Up to 69 days)
- Part B (MAD): Volume of distribution at steady state (Vss)(Up to 69 days)
- Part A (SAD) and Part B (MAD): Percent change from Baseline in pharmacodynamic (PD) parameters(Up to 56 days (Part A) and up to 69 days (Part B))
- Part A (SAD) and Part B (MAD): Maximum percent change from Baseline (Emax) in PD parameters(Up to 56 days (Part A) and up to 69 days (Part B))
- Part A (SAD) and Part B (MAD): Time to maximum percent change from Baseline (TEmax) in PD parameters(Up to 56 days (Part A) and up to 69 days (Part B))
- Part A (SAD) and Part B (MAD): Time below Baseline in PD parameters(Up to 56 days (Part A) and up to 69 days (Part B))
- Part A (SAD) and Part B (MAD): AUC below Baseline in PD parameters(Up to 56 days (Part A) and up to 69 days (Part B))
- Part A (SAD) and Part B (MAD): Number of serum samples with Positive antidrug antibodies (ADAs) binding to CSL040(Up to 56 days (Part A) and up to 69 days (Part B))
- Part A (SAD) and Part B (MAD): Number of participants with presence of treatment-emergent ADAs(Up to 56 days (Part A) and up to 69 days (Part B))
Investigators
Study Sites (1)
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