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| Name | Class |
|---|---|
| ChainGen Biopharma (Australia) Pty Ltd | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Cohorts 1-5 each has 2 participants who will receive placebo, 10 in total. |
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| Active Comparator | Active Comparator | Cohorts 1-5 each has 2 participants will receive active comparator, 10 in total. |
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| CGB3002 0.08 mg/kg | Experimental | Healthy participants will be administered a single intravenous dose of CGB3002 (0.08 mg/kg). |
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| CGB3002 0.4 mg/kg | Experimental | Healthy participants will be administered a single intravenous dose of CGB3002 (0.4 mg/kg). |
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| CGB3002 1.2 mg/kg | Experimental | Healthy participants will be administered a single intravenous dose of CGB3002 (1.2 mg/kg). |
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| CGB3002 3.6 mg/kg | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGB3002 0.08 mg/kg | Drug | Cohorts 1: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 0.08 mg/kg. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage 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. | up to Day 15 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| PK of CGB3002: Maximum Concentration (Cmax) | Cmax after single intravenous infusion of CGB3002 based on non-compartmental analysis. | up to 8 weeks |
| PK of CGB3002: time attain to Cmax (Tmax) | Tmax after single intravenous infusion of CGB3002 based on non-compartmental analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ofer Gonen, M.D. | Contact | (03) 8593 9801 | o.gonen@nucleusnetwork.com.au |
| Name | Affiliation | Role |
|---|---|---|
| Zhizheng Zhang, M.D. | ChainGen Biopharma Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Recruiting | Melbourne | Victoria | 3004 | Australia |
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Healthy participants will be administered a single intravenous dose of CGB3002 (3.6 mg/kg).
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| CGB3002 7.2 mg/kg | Experimental | Healthy participants will be administered a single intravenous dose of CGB3002 (7.2 mg/kg). |
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| CGB3002 0.4 mg/kg | Drug | Cohorts 2: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 0.4 mg/kg. |
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| CGB3002 1.2 mg/kg | Drug | Cohorts 3: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 1.2 mg/kg. |
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| CGB3002 3.6 mg/kg | Drug | Cohorts 4: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 3.6 mg/kg. |
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| CGB3002 7.2 mg/kg | Drug | Cohorts 5: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 7.2 mg/kg. |
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| Placebo | Drug | Healthy participants will be administered a single intravenous dose of matching placebo. |
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| Comparator Drug | Drug | Healthy participants will receive a single intravenous dose of the comparator drug at the same dose level as CGB3002. |
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| 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. | 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. | 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. | up to 8 weeks |
| PK of CGB3002: the total body clearance (CL) | CL after single intravenous infusion of CGB3002 based on non-compartmental analysis. | 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. | 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. | 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. | up to 8 weeks |