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

NCT ID: NCT05095168

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-22
• Study Completion Date: 2021-11-30

Brief Summary

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.

Conditions

PNH

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Single Ascending Dose (SAD)

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.

Group Type: EXPERIMENTAL

CAN106

Intervention Type: DRUG

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

placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo

Interventions

CAN106

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

Intervention Type: DRUG

Placebo

placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CARE Pharma Shanghai Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National University Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

CAN106-HV-101

Identifier Type: -

Identifier Source: org_study_id