Skip to main content
OpenTrials
Completed

NCT Number: NCT05095168

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

PNH

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National University Hospital

Singapore

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CAN106

Drug

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

Placebo

Drug

placebo

Primary outcomes

  1. Incidence of subjects with dose-limiting toxicity (DLTs)

    Time frame: 6-months after dosing

    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.

  2. Incidence of adverse events (AEs)

    Time frame: 6-months after dosing

    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.

  3. Incidence of severe adverse events (SAEs)

    Time frame: 6-months after dosing

    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))

Secondary outcomes

  1. PK parameters - tmax

    Time frame: 6-months after dosing

    time to reach maximum of concentration (days)

  2. PK parameters-Cmax

    Time frame: 6-months after dosing

    peak plasma concentration

  3. PK parameters - AUC0-t

    Time frame: 6-months after dosing

    Area under the plasma concentration versus time curve to the last visit (AUCt)

  4. PK parameters - t1/2

    Time frame: 6-months after dosing

    terminal elimination half-life

  5. PD endpoints-free C5

    Time frame: 6-months after dosing

    maximal change from baseline in free C5 concentrations at each of scheduled post baseline assessment time-points (µg/ml);

  6. PD endpoints-CH50

    Time frame: 6-months after dosing

    maximal change from baseline total complement activity (CH50) at each of scheduled post baseline assessment time-points (%);

  7. PD endpoints-total C5

    Time frame: 6-months after dosing

    meausure the absolute change from baseline in total C5 concentrations at each of scheduled post baseline assessment time-points (µg/ml);

  8. Immunogenicity

    Time frame: 6-months after dosing

    Anti-drug Antibody (ADA) titers

Sponsors and collaborators

Lead sponsor

CARE Pharma Shanghai Ltd.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 27, 2021
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.