Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06213259
Status:
RECRUITING
Last Update Posted:
2024-02-02
First Post:
2023-12-25
Brief Title:
A Study of KD6005 in Healthy Participants and Participants With Rheumatoid Arthritis RA
Sponsor:
Shanghai Kanda Biotechnology Co Ltd
Organization:
Shanghai Kanda Biotechnology Co Ltd
Study Overview
Official Title:
A Phase 1 Randomised Double-blind Placebo-controlled Study to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Pharmacodynamics of KD6005 in Healthy Participants and Participants With Rheumatoid Arthritis RA
Status:
RECRUITING
Status Verified Date:
2023-12
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 phase 1 study will consist of two parts Phase 1a is a single-dose study and will evaluate the safety tolerability pharmacokinetics PK and preliminary pharmacodynamics PD in healthy participants Phase 1b is a multiple doses study and will evaluate the safety tolerability PK and preliminary PD in participants with rheumatoid arthritis RA
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