Single and Multiple Ascending Dose Study in Healthy Participants and Participants With an Autoimmune Disease
← catalyst calendarSponsored by Almirall, S.A. (industry) · ALM.MC — their whole pipeline →.
Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
69actual
Sites
3
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-07-29 | actual | When the study began enrolling |
| Primary completion | 2025-04-03 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-04-03 | actual | The whole study's end, after follow-up |
| First posted | 2024-07-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-11-24 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Healthy Volunteers
- Autoimmune Disease
Interventions
- Drug: LAD191
- Other: Placebo
Primary outcomes
what the primary-completion date above is the date OFPart 1: Number of Participants with Adverse Events (AEs) and Severity of AEs
measured Baseline up to Day 73
Part 1: Number of Participants who have Dose-limiting Adverse Reactions
measured Baseline up to Day 73
Part 1: Number of Participants with Clinically Significant Changes from Baseline in Vital Sign Parameter
measured Baseline up to Day 73
Part 1: Number of Participants with Clinically Significant Changes from Baseline in Physical Examination Findings
measured Baseline up to Day 73
Part 1: Number of Participants with Clinically Significant Changes from Baseline in Electrocardiograms (ECGs) Parameters
measured Baseline up to Day 73
Part 1: Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters
measured Baseline up to Day 73
Part 2 and 3: Number of Participants with Adverse Events (AEs) and Severity of AEs
measured Baseline up to Day 94
Part 2 and 3: Number of Participants who have Dose-limiting Adverse Reactions
measured Baseline up to Day 94
Part 2 and 3: Number of Participants with Clinically Significant Changes from Baseline in Vital Sign Parameter
measured Baseline up to Day 94
Part 2 and 3: Number of Participants with Clinically Significant Changes from Baseline in Physical Examination Findings
measured Baseline up to Day 94
Part 2 and 3: Number of Participants with Clinically Significant Changes from Baseline in ECGs Parameters
measured Baseline up to Day 94
Part 2 and 3: Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters
measured Baseline up to Day 94
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