NCT05539248View on ClinicalTrials.gov

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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

March 25, 2022

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2025

Conditions
PNHHemolysis
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."

Trial Locations (1)

100730

RECRUITING

Peking Union Medical College Hospital, Beijing

All Listed Sponsors
lead

CARE Pharma Shanghai Ltd.

INDUSTRY