Single and Multiple Ascending Dose Study in Healthy Participants and Participants With an Autoimmune Disease
NCT06488209 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69
Last updated 2025-11-24
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.
Conditions
- Healthy Volunteers
- Autoimmune Disease
Interventions
- DRUG
-
LAD191
LAD191 SC injection.
- OTHER
-
Placebo
Matching placebo SC injection.
Sponsors & Collaborators
-
Almirall, S.A.
lead INDUSTRY
Principal Investigators
-
Study Director · Almirall, S.A.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-07-29
- Primary Completion
- 2025-04-03
- Completion
- 2025-04-03
- FDA Drug
- Yes
Countries
- United States
Study Locations
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