Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single site, single dose escalation study in healthy subject with CAN106. The study is to assess the safety and tolerability of single escalating doses of CAN106; to characterize the PK and PD profile of CAN106; and to evaluate the immunogenicity of CAN106 injection.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose (SAD) | Experimental | In the SAD arm subjects will be sequentially included in one of up to six cohorts (dose levels). Additional subjects may be added in any cohort if necessary. |
|
| placebo | Placebo Comparator | In the SAD arm subjects will be sequentially included in one of up to six cohorts (dose levels). In higher dose levels, subjects will be randomized to receive the treatment or placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAN106 | Drug | CAN106 is a selective inhibitor of complement activation, which binds to the complement component C5. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of subjects with dose-limiting toxicity (DLTs) | TEAEs will be categorized as per the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria. a DLT is defined as one subject with a Grade 3 AE or higher, that are assessed as drug-related by the site investigator. | 6-months after dosing |
| Incidence of adverse events (AEs) | An AE is defined as any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | 6-months after dosing |
| Incidence of severe adverse events (SAEs) | Any untoward medical occurrence that at any dose:
| 6-months after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters - tmax | time to reach maximum of concentration (days) | 6-months after dosing |
| PK parameters-Cmax | peak plasma concentration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Singapore | Singapore |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | placebo |
|
| 6-months after dosing |
| PK parameters - AUC0-t | Area under the plasma concentration versus time curve to the last visit (AUCt) | 6-months after dosing |
| PK parameters - t1/2 | terminal elimination half-life | 6-months after dosing |
| PD endpoints-free C5 | maximal change from baseline in free C5 concentrations at each of scheduled post baseline assessment time-points (µg/ml); | 6-months after dosing |
| PD endpoints-CH50 | maximal change from baseline total complement activity (CH50) at each of scheduled post baseline assessment time-points (%); | 6-months after dosing |
| PD endpoints-total C5 | meausure the absolute change from baseline in total C5 concentrations at each of scheduled post baseline assessment time-points (µg/ml); | 6-months after dosing |
| Immunogenicity | Anti-drug Antibody (ADA) titers | 6-months after dosing |