Ignite Creation Date:
2024-07-17 @ 11:04 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488209
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-28
Brief Title:
Single and Multiple Ascending Dose Study in Healthy Participants and Participants With an Autoimmune Disease
Sponsor:
Almirall SA
Organization:
Almirall SA
Study Overview
Official Title:
A Phase 1 Randomized 3-Part Placebo-Controlled Single Ascending and Multiple Ascending Dose Study to Assess Safety Tolerability Pharmacokinetics Immunogenicity and Pharmacodynamics of LAD191 in Healthy Subjects and Subjects With an Autoimmune Disease
Status:
RECRUITING
Status Verified Date:
2024-10
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 main purpose of this study is to to evaluate the safety tolerability pharmacokinetics PK pharmacodynamics PD immunogenicity of LAD191 in healthy adults and in adults with an autoimmune disease
Detailed Description:
This is a 3-part study Part 1 will be comprised of up to 5 cohorts of healthy adult participants and will investigate single ascending doses of LAD191 Part 2 will be comprised of up to 3 cohorts of healthy adult participants and will investigate multiple ascending doses of LAD191 Part 3 will be comprised of single cohort of participants with an autoimmune disease and will investigate repeat doses of LAD191 Each ascending dose level will be investigated by a sequential cohort with dose escalation based on satisfactory safety tolerability PK PD immunogenicity biomarker and clinical response assessments will be performed throughout
Each cohort will be randomized to receive LAD191 and placebo
Each participant will participate for about 14 weeks in Part 1 17 weeks in Part 2 and 18 weeks in Part 3 of the study
Each cohort will be randomized to receive LAD191 and placebo
Each participant will participate for about 14 weeks in Part 1 17 weeks in Part 2 and 18 weeks in Part 3 of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None