Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310746
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-03-07
Brief Title:
A Randomized Double-Blind Placebo-Controlled Single-Dose Escalation Phase I Clinical Study to Assess the Safety Pharmacokinetics and Immunogenicity of HLX6018 in Healthy Subjects
Sponsor:
Shanghai Henlius Biotech
Organization:
Shanghai Henlius Biotech
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Single-Dose Escalation Phase I Clinical Study to Assess the Safety Pharmacokinetics and Immunogenicity of HLX6018 in Healthy Subjects
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the safety PK and immunogenicity of a single intravenous administration of HLX6018 in healthy subjects based on the preliminary efficacy and safety established through in vitro and in vivo experiments
This is a randomized double-blind placebo-controlled study with single dose escalation design to assess the safety PK and immunogenicity of HLX6018 in healthy subjects It is planned to enroll 8-10 subjects in each of seven dose groups 025 mgkg 10 mgkg 40 mgkg 12 mgkg 25 mgkg 50 mgkg and 70 mgkg This is the first-in-human study of the investigational product
This is a randomized double-blind placebo-controlled study with single dose escalation design to assess the safety PK and immunogenicity of HLX6018 in healthy subjects It is planned to enroll 8-10 subjects in each of seven dose groups 025 mgkg 10 mgkg 40 mgkg 12 mgkg 25 mgkg 50 mgkg and 70 mgkg This is the first-in-human study of the investigational product
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None