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

NCT05095168 | Completed Phase 1

• 1 other identifier: CAN106-HV-101
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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.

  6-months after dosing

• Incidence of adverse events (AEs)

  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.

  6-months after dosing

• Incidence of severe adverse events (SAEs)

  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))

  6-months after dosing

Secondary Outcomes (8)

• PK parameters - tmax

  6-months after dosing

• PK parameters-Cmax

  6-months after dosing

• PK parameters - AUC0-t

  6-months after dosing

• PK parameters - t1/2

  6-months after dosing

• PD endpoints-free C5

  6-months after dosing

Study Arms (2)

Single Ascending Dose (SAD)

EXPERIMENTAL

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.

Drug: CAN106

placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

CAN106 DRUG

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

Single Ascending Dose (SAD)

Placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CARE Pharma Shanghai Ltd.: lead

Study Sites (1)

National University Hospital

Singapore, Singapore

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 27, 2021
• Study Start: February 22, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

SG (1)