NCT05539248

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

A Multicenter, Open-label, Multiple Ascending Dose Phase 1b/2 Trial to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of CAN106 Intravenously in Subjects With PNH Naïve to Complement-Inhibitor Treatment

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: CARE Pharma Shanghai Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label, multiple dose escalation study to assess the safety, tolerability, efficacy, PK, PD and immunogenicity of CAN106 given as an IV infusion. The data presented is up to the primary completion date of the study and is for the 26-week primary evaluation period. The study also includes an extension period of up to 52 weeks.

Conditions

• PNH
• Hemolysis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-25
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2022-09-14
• Last updated: 2022-09-14

Locations

1 site across 1 country: China