Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Ascending Dose (SAD) of CAN106 Administered Intravenously (IV) in Healthy Subjects

CARE Pharma Shanghai Ltd.31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

PNH

Interventions

CAN106DRUG

CAN106 is a selective inhibitor of complement activation, which binds to the complement component C5.

PlaceboDRUG

placebo

Eligibility

Sex: ALLMin age: 21 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects must be able to understand and provide informed consent. * Males or females, between 21 and 45 years of age, inclusive; * Body mass index must be within the range of 18.5 to 32.0 kg/m2; * 12-lead electrocardiogram (ECG) within normal limits with no clinically significant abnormalities in the opinion of the Investigator； * Systolic blood pressure ≤140 mmHg and a diastolic blood pressure of ≤ 90 mmHg after 5 minutes with supine rest； * non-pregnancy * meningococcal vaccinations for at least 2 weeks before dosing Exclusion Criteria: * Disease or conditions interfere with participating the trial * Active serious mental illness or psychiatric disorder * clinically relevant abnormal test results in hepatic function * unacceptable CBC lab test * asymptomatic complement deficiency * Any other clinical safety laboratory test * HIV, HBV, HCV positive * Alcohol and drug abuse * etc.

Locations (1)

National University Hospital

Singapore, Singapore

Outcomes

Primary Outcomes

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.