This is a randomized, double-blind, placebo-controlled phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of single ascending IV doses of CGB3002 in healthy participants. CGB3002 is being developed to treat Alzheimer's Disease.
This study includes 5 planned sequential cohorts. Participants will be randomized to receive a single IV dose of CGB3002, active comparator or placebo, with doses administered in ascending order. Based on the emerging data, there will be options to adjust the number of participants on active or placebo per subsequent dose level, and doses may be repeated or adjusted based on safety, tolerability and plasma pharmacokinetic data. Optional cohorts may be added to evaluate an intermediate dose level or to expand the dose level by SRC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
46
Cohorts 1: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 0.08 mg/kg.
Cohorts 2: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 0.4 mg/kg.
Cohorts 3: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 1.2 mg/kg.
Nucleus Network
Melbourne, Victoria, Australia
RECRUITINGPercentage of Participants with Adverse Events as a Measure of Safety and Tolerability
Safety assessment variables will include all adverse events (AEs) including AEs, physical examinations, neurological examinations, vital sign measurements, electrocardiograms, laboratory parameters.
Time frame: up to Day 15 weeks.
PK of CGB3002: Maximum Concentration (Cmax)
Cmax after single intravenous infusion of CGB3002 based on non-compartmental analysis.
Time frame: up to 8 weeks
PK of CGB3002: time attain to Cmax (Tmax)
Tmax after single intravenous infusion of CGB3002 based on non-compartmental analysis.
Time frame: up to 8 weeks
PK of CGB3002: Apparent terminal half-life (T1/2)
T1/2 after single intravenous infusion of CGB3002 based on non-compartmental analysis.
Time frame: up to 8 weeks
PK of CGB3002: Area under the plasma concentration versus time curve from zero to t h post-dose (AUC0-t)
AUC0-t after single intravenous infusion of CGB3002 based on non-compartmental analysis.
Time frame: up to 8 weeks
PK of CGB3002: Area under the plasma concentration versus time curve extrapolated to infinity (AUC0-inf)
AUC0-inf after single intravenous infusion of CGB3002 based on non-compartmental analysis.
Time frame: up to 8 weeks
PK of CGB3002: the total body clearance (CL)
CL after single intravenous infusion of CGB3002 based on non-compartmental analysis.
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Cohorts 4: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 3.6 mg/kg.
Cohorts 5: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 7.2 mg/kg.
Healthy participants will be administered a single intravenous dose of matching placebo.
Healthy participants will receive a single intravenous dose of the comparator drug at the same dose level as CGB3002.
Time frame: up to 8 weeks
PK of CGB3002: Volume of distribution during the terminal phase (Vz)
Vz after single intravenous infusion of CGB3002 based on non-compartmental analysis.
Time frame: up to 8 weeks
Concentration ratio of CSF to plasma
CSF concentrations were measured by a specific and validated method. Concentration ratio of CSF to plasma on Day 3 post dose will be calculated.
Time frame: Day 3
Incidence of anti-CGB3002 antibodies (ADAs)
For each dose group, the numbers and proportions of participants who were positive or negative for anti-drug antibodies (ADA) at baseline (baseline prevalence) and after study drug administration (post-baseline incidence during the treatment and follow-up periods) were summarized.
Time frame: up to 8 weeks