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

CARE Pharma

Status and phase: Completed; Phase 1

Conditions: PNH

Treatments: Drug: Placebo; Drug: CAN106

Study type: Interventional

Funder types: Industry

Identifiers

NCT05095168

CAN106-HV-101

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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31 participants in 2 patient groups, including a placebo group

Single Ascending Dose (SAD)

Experimental group

Description:

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.

Treatment:

Drug: CAN106

placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo