Safety, tolerability, pharmacokinetics and pharmacodynamics of CBP-201 in healthy volunteers

The study will enroll 5 cohorts of subjects who will be randomized to receive a single dose of CBP-201 or placebo. Four of the 5 cohorts will receive study drug via subcutaneous administration. The 5th cohort will receive drug via intravenous injection. Subjects will receive a single dose of CBP-201 or matching placebo administered by subcutaneous injection at a planned dose level of 75 mg, 150 mg, 300 mg or 600 mg (cohorts 1- 4 respectively). Cohort 5 will receive 300 mg of CBP-201 or placebo via intravenous injection. Each cohort will enroll 8 subjects, 6 to receive active and 2 to receive placebo. Sentinel subjects will be used with the initial cohort and with all dose escalations. If dosing of this sentinel participants proceed without clinically-significant adverse events (AEs) (as adjudicated by the Safety Monitoring Committee [SMC]), the remaining participants will be dosed. All subjects will remain under observation in the clinical center for 24 hours after receiving study drug to allow for PK sample collection, to assess for adverse events (AEs) and injection site reactions. After the last enrolled subject at a given dose level has completed Visit 4 (Day 15), the available blinded safety/tolerability data for that cohort will be reviewed by a Safety Review Committee (SRC) The SRC will determine if is safe to escalate to the next dose group. If all 5 cohorts are dosed, a total of 40 subjects will be enrolled (30 active; 10 placebo). Study duration will be for approximately 105 days or 113 if optional visit to only collect blood is required (30 days screening; 1 day for treatment, and 12 weeks post treatment follow-up plus the potential additional visit on Day 113). Screening will take place from day -30 to day -1. The study will be explained and participants will be asked to provide informed consent. Following consent, each potential subject will be examined before the start of the study to determine their eligibility for participation, including review of medical history and eligibility as per the inclusion/ exclusion criteria. Participants will be confined to the clinic from day -1 to day 2, with single dose administered on day 1. Subjects will receive their study injection in the morning of day 1, and will remain in the clinical centre for observation for the following 24 hour period. Blood samples will be taken at baseline and at various timepoints post dose throughout the day. Vital signs will be recorded every 15 mins for 1 hour post dose, and then every 4 hours. A post injection ECG will also be performed. Post treatment follow up visits will be conducted on day 2 before the subject is discharged, then subsequently as an outpatient on days 4,8,11,15,22,29,43,57 and 85. The follow up visits will record adverse events and concomitant meds, vital signs will be reviewed in addition to review of injection site findings. Bloods will be collected for safety and for pharmacokinetic and pharmacodynamics analysis. A 12-lead ECG will also be performed. There will be an optional day 113 PK visit which may be required to obtain a blood sample