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A Study on the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of CAN106 in Subjects With PNH

NCT05539248 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2022-09-14

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of CAN106 administered intravenously to subjects with PNH who have not previously been treated with a complement inhibitor.

Conditions

  • PNH
  • Hemolysis

Interventions

DRUG

CAN106 20 mg/kg

Induction and maintenance dosing for cohort 1: 12 mg/kg on Day 1, 16 mg/kg on Day 8, and 20 mg/kg on Day 15 and every 4 weeks thereafter;

DRUG

CAN106 40 mg/kg

Induction and maintenance dosing for cohort 2: 30 mg/kg on Day 1, and 40mg/kg on Day 8 and every 4 weeks thereafter；

DRUG

CAN106 80 mg/kg

Induction and maintenance dosing for cohort 3: 60 mg/kg on day 1, and 80 mg/kg on day 15 and every 8 weeks thereafter.

Sponsors & Collaborators

  • CARE Pharma Shanghai Ltd.

    lead INDUSTRY

Principal Investigators

  • Bing Han, MD · Peking Union Medical College Hospital

  • Hongzhong Liu, MMed · Peking Union Medical College Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-25
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05539248 on ClinicalTrials.gov