A Phase 1 interventional study of CAN106 and Placebo in PNH, sponsored by CARE Pharma Shanghai Ltd.. Completed at 1 site in Singapore. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-25.
Sponsored by CARE Pharma Shanghai Ltd. · Phase 1, Interventional, and Treatment
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.
CARE Pharma Shanghai Ltd. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: CAN106
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.
Drug: Placebo
CAN106 is a selective inhibitor of complement activation, which binds to the complement component C5.
placebo
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.
Time frame: 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.
Time frame: 6-months after dosing
Incidence of severe adverse events (SAEs)
Any untoward medical occurrence that at any dose: * Results in death, * Is life-threatening, * Requires inpatient hospitalization or prolongation of existing hospitalization, * Results in persistent or significant disability/incapacity, or * Is a congenital anomaly/birth defect. (ICH E6 (R2))
Time frame: 6-months after dosing
PK parameters - tmax
time to reach maximum of concentration (days)
Time frame: 6-months after dosing
PK parameters-Cmax
peak plasma concentration
Time frame: 6-months after dosing
PK parameters - AUC0-t
Area under the plasma concentration versus time curve to the last visit (AUCt)
Time frame: 6-months after dosing
PK parameters - t1/2
terminal elimination half-life
Time frame: 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);
Time frame: 6-months after dosing
PD endpoints-CH50
maximal change from baseline total complement activity (CH50) at each of scheduled post baseline assessment time-points (%);
Time frame: 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);
Time frame: 6-months after dosing
Immunogenicity
Anti-drug Antibody (ADA) titers
Time frame: 6-months after dosing
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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CARE Pharma Shanghai Ltd.