Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06144710
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2023-11-13
Brief Title:
SG301-SC Injection Safety Study in Subjects With Systemic Lupus Erythematosus
Sponsor:
Hangzhou Sumgen Biotech Co Ltd
Organization:
Hangzhou Sumgen Biotech Co Ltd
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Phase 1 Clinical Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamic Characteristics of SG301 SC Injection in Single-dose Healthy Subjects and Multiple-dose Systemic Lupus Erythematosus SLE Subjects
Status:
RECRUITING
Status Verified Date:
2024-07
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:
This is a randomized double-blind placebo-controlled phase I clinical study to evaluate the safety tolerability pharmacokinetics and pharmacodynamics of single dose in healthy volunteers and multiple doses of SG301 SC injection in participants with systemic lupus erythematosus SLE
Detailed Description:
This is a phase I single ascending dose SAD study in healthy volunteers and multiple ascending dose MAD study in participants with mild or moderate SLE which consists of Parts A and B Part A adopts a single-center open-label dose escalation trial design and Part B adopts a multi-center randomized double-blind placebo-controlled trial design to evaluate the safety tolerability PK and immunogenicity preliminary efficacy of SG301 SC Injection in patients with mild to moderate SLE
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