Healthy VolunteersPhase 1NCT06488209
Single and Multiple Ascending Dose Study in Healthy Participants and Participants With an Autoimmune Disease
A Phase 1 study testing LAD191 in people with Healthy Volunteers and Autoimmune Disease, run by Almirall, S.A. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Autoimmune Disease
- What is being tested?
- LAD191
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Jul 2022to 3 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (Applicable to Both Healthy and an Autoimmune Disease Participants Unless Indicated Otherwise)
- Participant provides written informed consent prior to any protocol related procedures, including screening evaluations. Participant must be able to understand the consent form and instructions and to provide consent directly; no guardian/legal representative or caregiver may provide consent for the participant.
- Male or female, greater than or equal to (>=)18 and less than or equal to (<=) 65 years of age, with a body mass index (BMI) within the range of 18.5 to 29.9 kilogram per square meter (kg/m^2) (inclusive) and body weight of >=50 kilograms (kg).
- Participant is healthy, in the clinical judgement of the Investigator, based medical history, physical examination, vital signs, ECG, and laboratory investigations (i.e., has clinical laboratory tests that are within the reference ranges or are clinically acceptable per Investigator judgment).
- Participant has a seated systolic blood pressure (SBP) >=90 mm Hg and <=140 mm Hg or a seated diastolic BP (DBP) >=50 mm Hg or <=90 mm Hg.
- Participant is willing and able to understand and comply with all aspects of the protocol.
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- Participant must agree to the following requirements during the study:
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result within 7 days prior to first dosing plus a negative urine pregnancy test pre-dose on Day 1 and must be willing to use a highly effective form of contraception (ICH E8 Guideline, 1997; (ICH M3 [R2] Guidance, 2009; (FDA M3 [R2] Guidance, 2010) for the duration of the study and for at least 3 months after the last dose of study medication. Methods like periodic abstinence, post-ovulation procedures and withdrawal are not considered adequate.
- Males with partners of childbearing potential must be willing to use condoms in combination with a second effective method of contraception during the study. Male participants must continue to use contraception (condoms plus a second effective method) for 165 days following administration of the study drug.
- Male participants must agree not to donate sperm during the study and for 165 days following administration of the study drug.
- Participants with an Autoimmune Disease (Cohort 9 Only):
- For participants with an autoimmune disease, the inclusion criteria for healthy participants listed above apply, with the following changes/additions:
- Male or female, >=18 to <=65 years of age, with a BMI within the range 18.5 to 34.9 kg/ m^2, and body weight of >=50 kg.
- Current diagnosis of an autoimmune disease by the Investigator and with signs and symptoms consistent with an autoimmune disease for at least 3 months prior to Day -1 (baseline).
Who cannot join
- (Applicable to Both Healthy and an Autoimmune Disease Participants Unless Indicated Otherwise)
- Participant has received treatment with LAD191 previously.
- Known hypersensitivity to LAD191 or any of its excipients.
- Hypersensitivity or reaction to a prior biologic (antibody-based) therapy (regardless of indication), that was clinically significant, as per judgment of Investigator.
- History of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, inflammatory, or allergic disease (including drug allergies, any active seizure disorder requiring therapy with antiepileptic drugs, active peptic ulcer disease, gastrointestinal bleeding, chronic gastritis, inflammatory bowel disease or chronic diarrhea, but excluding mild seasonal allergies or stable, well-controlled thyroiditis). Note that participants with thyroid hormone deficiency, hypertension, hyperlipidemia, or diabetes mellitus may be included in Part 3 of the study.
- Active chronic or acute infection requiring treatment with systemic antimicrobials, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Day -1, or superficial skin infections within 4 weeks prior to Day -1, or fever > 38°C during within 1 week before Day -1.
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- A positive test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) on Day -1, or the second negative test after a previous SARS CoV-2 infection was <=14 days before Day -1, or the participant's SARS CoV-2-associated symptoms resolved <=14 days before Day -1.
- Presence of skin comorbidities that may interfere with study assessments, in the opinion of the Investigator.
- Participant has current tuberculosis (TB) or any history of active or latent TB, regardless of prior treatment.
- History of malignancy, regardless of outcome.
- Participant has any condition that, in the opinion of the Investigator, would interfere with the PK evaluation of LAD191 or participant safety or the interpretation of study results
- Clinically significant ECG abnormality, including, but not limited to, the following:
- An abnormal PR interval (>=220 msec or <=100 msec).
- QTc prolongation (corrected QT interval by Fredericia's formula [QTcF] >=450 msec).
- Mean heart rate <=45 bpm or >100 bpm.
- Known history of liver disease or clinically significant abnormal (as per judgment of Investigator) liver function test(s) at Screening (ALT, AST, alkaline phosphatase [ALP], or TBili >1.5 x ULN).
- Impaired renal function (laboratory values out of the normal range that are clinically significant, as judged by the Investigator).
- Congenital or acquired immunosuppressive condition that would put participant at risk during the study, per Investigator judgment.
- Neutropenia; defined as a neutrophil count <2.0 x 10^9/L, at Screening.
- Participant has had major surgery (requiring general anesthesia) within 3 months prior to Day -1, or has major surgery planned during the study. For participants with an autoimmune disease may have had incision and drainage of abscesses up to 1 week before Day -1).
- Participant has donated plasma or blood or has lost more than 450 ml blood in the 60 days prior to Day -1, or intends to donate blood during the study or in the 60 days after the last scheduled study visit.
- Participant is pregnant or breastfeeding (or is planning to become pregnant or breastfeed during the study or within 90 days after the last dose of study drug).
- History of, or positive test result at Screening for, hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen (anti-HBcAg), antibody to the hepatitis C virus (anti-HCV), or antibody to the human immunodeficiency virus (HIV-1/2).
- Participant has taken any medications, including over-the-counter (OTC) medications, within 14 days (or at least 5 half-lives, whichever is longer) before Day -1. (Note that hormonal contraceptives are allowed, and acetaminophen is permitted at doses <=2 g/day up to 48 hours prior to each study visit).
- Participant has received any type of live or attenuated vaccinations within 28 days prior to Screening, or is planning to receive any such vaccine during the study (inactive vaccines are allowed) or has received a SARS-CoV-2 vaccine within 14 days of Day 1.
- Participant has received any investigational drug in any clinical study within 30 days (or at least 5 half-lives, whichever is longer) prior to Day -1, or is on extended follow-up from such a clinical study.
- Participant has a history (within 2 years prior to Screening) of alcohol or drug abuse, as per Investigator judgment, or has a positive urine screen for drugs of abuse (opiates, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, cotinine, phencyclidine) at Screening or on Day -1, or a positive urine alcohol test at Screening or on Day -1.
- Consumption of alcohol within 48 hours (2 days) before Day -1.
- Participant is involved in strenuous physical activity or contact sports within 96 hours (4 days) prior to Day -1.
- Consumption of any foods containing poppy seeds within 48 hours (2 days) prior to Screening and Day -1 as this could result in a false positive drug screen result.
- Participant has any other serious or uncontrolled physical or mental dysfunction that, as judged by the Investigator, could place the participant at higher risk derived from his/her participation in the trial, could confound the results of the trial or is likely to prevent the participant from complying with the requirements of the trial or completing the trial.
- Participant is an employee or relative of the Sponsor/vendors, clinical study site, or is an individual or employee directly involved with the conduct of the study or is an immediate family member of such an individual.
- Participants with an Autoimmune Disease (Cohort 9 Only)
- For participants with an autoimmune disease, the exclusion criteria for healthy participants listed above apply, with the following additions:
- 1. Concurrent use of the following medications/treatments:
- Systemic immunosuppressants/immunomodulators or other systemic treatments for autoimmune disease within 28 days or 5 half-lives (whichever is longer) before Day -1.
- Systemic antivirals or antifungals within 28 days prior to Day -1, or systemic antibiotics within 28 days prior to Day -1.
- Oral analgesics including opioids within 14 days prior to Day -1, except for acetaminophen at doses of <=2 g/day for relief of autoimmune disease-associated pain.
- Prescription and OTC medications other than those used for the treatment of an autoimmune disease within 14 days or 5 half-lives (whichever is longer) before Day -1, except for hormonal contraceptives, thyroid replacement medications, and medications used for the treatment of hypertension, diabetes mellitus (but not metformin), or hyperlipidemia which are permitted provided the medication(s) and dosage (dose and frequency) have been stable for at least 6 weeks prior to Day -1. Note that participants with thyroid hormone deficiency, hypertension, diabetes mellitus, or hyperlipidemia may be included in Part 3 of the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Doral Medical Research
Miami, Florida, 33165
Jennifer Parish, MD
Philadelphia, Pennsylvania, 19103
ICON Early Phase Services, LLC
San Antonio, Texas, 78209
About this study
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
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.
Read the 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.
- Conditions
- Healthy Volunteers, Autoimmune Disease
- Being tested
- LAD191, Placebo
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAD191Drug
LAD191 SC injection.
PlaceboOther
Matching placebo SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: LAD191 (Cohort 1) | Experimental | Participants will receive single ascending dose of LAD191 subcutaneous (SC) injection on Day 1. Receives: Drug: LAD191 |
| Part 1: LAD191 (Cohort 2) | Experimental | Participants will receive single ascending dose of LAD191 SC injection on Day 1. Receives: Drug: LAD191 |
| Part 1: LAD191 (Cohort 3) | Experimental | Participants will receive single ascending dose of LAD191 SC injection on Day 1. Receives: Drug: LAD191 |
| Part 1: LAD191 (Cohort 4) | Experimental | Participants will receive single ascending dose of LAD191 SC injection on Day 1. Receives: Drug: LAD191 |
| Part 1: LAD191 (Cohort 5) | Experimental | Participants will receive single ascending dose of LAD191 SC injection on Day 1. Receives: Drug: LAD191 |
| Part 1: Placebo | Placebo comparator | Participants will receive single dose of matching placebo SC injection on Day 1 (Cohort 1 to Cohort 5). Receives: Other: Placebo |
| Part 2: LAD191 (Cohort 6) | Experimental | Participants will receive multiple ascending doses of LAD191 SC injection on Days 1, 8, 15, 22, 29 and 36. Receives: Drug: LAD191 |
| Part 2: LAD191 (Cohort 7) | Experimental | Participants will receive multiple ascending doses of LAD191 SC injection on Days 1, 8, 15, 22, 29 and 36. Receives: Drug: LAD191 |
| Part 2: LAD191 (Cohort 8) | Experimental | Participants will receive multiple ascending doses of LAD191 SC injection on Days 1, 8, 15, 22, 29 and 36. Receives: Drug: LAD191 |
| Part 2: Placebo | Placebo comparator | Participants will receive multiple doses of matching placebo SC injection on Days 1, 8, 15, 22, 29 and 36 (Cohort 6 to Cohort 8). Receives: Other: Placebo |
| Part 3: LAD191 (Cohort 9) | Experimental | Participants will receive repeat doses of LAD191 SC injection on Days 1, 8, 15, 22, 29 and 36. Receives: Drug: LAD191 |
| Part 3: Placebo | Placebo comparator | Participants will receive repeat doses of matching placebo SC injection on Days 1, 8, 15, 22, 29 and 36 (Cohort 9). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 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
Secondary outcomes (41)
Part 1: Maximum Serum Concentration (Cmax) of LAD191
Measured: Pre-dose, 4 hours and 8 hours post-dose on Days 1, 2, 3, 4, 6, 8, 15, 22, 29, 43, 57 and 71
Part 1: Time to Reach Maximum Serum Concentration (Tmax) of LAD191
Measured: Pre-dose, 4 hours and 8 hours post-dose on Days 1, 2, 3, 4, 6, 8, 15, 22, 29, 43, 57 and 71
Part 1: Area Under the Serum Concentration-time Curve from Zero to Time of the Last Quantifiable Concentration (AUC0-t) of LAD191
Measured: Pre-dose, 4 hours and 8 hours post-dose on Days 1, 2, 3, 4, 6, 8, 15, 22, 29, 43, 57 and 71
Part 1: Area Under the Serum Concentration-time Curve from Zero to infinity (AUC0-inf) of LAD191
Measured: Pre-dose, 4 hours and 8 hours post-dose on Days 1, 2, 3, 4, 6, 8, 15, 22, 29, 43, 57 and 71
Part 1: Elimination Half-life (t½) of LAD191
Measured: Pre-dose, 4 hours and 8 hours post-dose on Days 1, 2, 3, 4, 6, 8, 15, 22, 29, 43, 57 and 71
Part 1: Apparent Total Serum Clearance (CL/F) of LAD191
Measured: Pre-dose, 4 hours and 8 hours post-dose on Days 1, 2, 3, 4, 6, 8, 15, 22, 29, 43, 57 and 71
Part 1: Apparent Volume of Distribution Associated with the Terminal Phase (Vd/F) of LAD191
Measured: Pre-dose, 4 hours and 8 hours post-dose on Days 1, 2, 3, 4, 6, 8, 15, 22, 29, 43, 57 and 71
Part 1: Number of Participants with Positive Anti-drug Antibodies (ADA) and Titer of ADA of LAD191
Measured: Pre-dose on Day 1; 24 hours post-dose on Days 15; 48 hours post-dose on Days 43 and 71
Part 2: Area Under the Serum Concentration-time Curve from Zero to Time of the Last Quantifiable Concentration (AUC0-t) of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Area Under the Concentration-time Curve within a Dosing Interval (AUCτau) of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Maximum Serum Concentration (Cmax) of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Time to Reach Maximum Serum Concentration (Tmax) of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Minimum Serum Concentrations (Cmin) of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Time to Cmin (tmin) of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Area Under the Serum Concentration-time Curve from Zero to Time of the Last Quantifiable Concentration (AUC0-t) at Steady State of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Area Under the Concentration-time Curve within a Dosing Interval (AUCτau) at Steady State of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Maximum Serum Concentration (Cmax) at Steady State of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Time to Reach Maximum Serum Concentration (Tmax) at Steady State of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Minimum Serum Concentrations (Cmin) at Steady State of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Time to Cmin (tmin) at Steady State of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Apparent Total Serum Clearance (CL/F) of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Apparent Volume of Distribution Associated with the Terminal Phase (Vd/F) of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Elimination Half-life (t½) of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Accumulation Ratios Based on AUC (R[AUC]) of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2 and 3: Number of Participants with Positive ADA and Titer of ADA of LAD191
Measured: Pre-dose on Days 1, 15, and 29; 4 hours post-dose on Days 43; 48 hours post-dose on 64 and 92
Part 3: Area Under the Serum Concentration-time Curve from Zero to Time of the Last Quantifiable Concentration (AUC0-t) of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Area Under the Concentration-time Curve within a Dosing Interval (AUCτau) of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Maximum Serum Concentration (Cmax) of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Time to Reach Maximum Serum Concentration (Tmax) of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Minimum Serum Concentrations (Cmin) of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Time to Cmin (tmin) of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Area Under the Serum Concentration-time Curve from Zero to Time of the Last Quantifiable Concentration (AUC0-t) at Steady State of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Area Under the Concentration-time Curve within a Dosing Interval (AUCτau) at Steady State of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Maximum Serum Concentration (Cmax) at Steady State of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Time to Reach Maximum Serum Concentration (Tmax) at Steady State of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Minimum Serum Concentrations (Cmin) at Steady State of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Time to Cmin (tmin) at Steady State of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Apparent Total Serum Clearance (CL/F) of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Apparent Volume of Distribution Associated with the Terminal Phase (Vd/F) of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Elimination Half-life (t½) of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Accumulation Ratios Based on AUC (R[AUC]) of LAD191
Measured: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start29 Jul 2022
- Primary completion3 Apr 2025
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Almirall, S.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Almirall, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488209
- Sponsor's protocol ID
- M-27134-01
- Status last verified
- Nov 2025
- First submitted
- 28 Jun 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06488209
- Acronym / sponsor ID
- M-27134-01
- Conditions
- Healthy Volunteers, Autoimmune Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 3 Apr 2025 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Part 1: LAD191 (Cohort 1) | Experimental | Drug: LAD191Participants will receive single ascending dose of LAD191 subcutaneous (SC) injection on Day 1. |
| Part 1: LAD191 (Cohort 2) | Experimental | Drug: LAD191Participants will receive single ascending dose of LAD191 SC injection on Day 1. |
| Part 1: LAD191 (Cohort 3) | Experimental | Drug: LAD191Participants will receive single ascending dose of LAD191 SC injection on Day 1. |
| Part 1: LAD191 (Cohort 4) | Experimental | Drug: LAD191Participants will receive single ascending dose of LAD191 SC injection on Day 1. |
| Part 1: LAD191 (Cohort 5) | Experimental | Drug: LAD191Participants will receive single ascending dose of LAD191 SC injection on Day 1. |
| Part 1: Placebo | Placebo comparator | Other: PlaceboParticipants will receive single dose of matching placebo SC injection on Day 1 (Cohort 1 to Cohort 5). |
| Part 2: LAD191 (Cohort 6) | Experimental | Drug: LAD191Participants will receive multiple ascending doses of LAD191 SC injection on Days 1, 8, 15, 22, 29 and 36. |
| Part 2: LAD191 (Cohort 7) | Experimental | Drug: LAD191Participants will receive multiple ascending doses of LAD191 SC injection on Days 1, 8, 15, 22, 29 and 36. |
| Part 2: LAD191 (Cohort 8) | Experimental | Drug: LAD191Participants will receive multiple ascending doses of LAD191 SC injection on Days 1, 8, 15, 22, 29 and 36. |
| Part 2: Placebo | Placebo comparator | Other: PlaceboParticipants will receive multiple doses of matching placebo SC injection on Days 1, 8, 15, 22, 29 and 36 (Cohort 6 to Cohort 8). |
| Part 3: LAD191 (Cohort 9) | Experimental | Drug: LAD191Participants will receive repeat doses of LAD191 SC injection on Days 1, 8, 15, 22, 29 and 36. |
| Part 3: Placebo | Placebo comparator | Other: PlaceboParticipants will receive repeat doses of matching placebo SC injection on Days 1, 8, 15, 22, 29 and 36 (Cohort 9). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- (Applicable to Both Healthy and an Autoimmune Disease Participants Unless Indicated Otherwise)
- Participant provides written informed consent prior to any protocol related procedures, including screening evaluations. Participant must be able to understand the consent form and instructions and to provide consent directly; no guardian/legal representative or caregiver may provide consent for the participant.
- Male or female, greater than or equal to (>=)18 and less than or equal to (<=) 65 years of age, with a body mass index (BMI) within the range of 18.5 to 29.9 kilogram per square meter (kg/m^2) (inclusive) and body weight of >=50 kilograms (kg).
- Participant is healthy, in the clinical judgement of the Investigator, based medical history, physical examination, vital signs, ECG, and laboratory investigations (i.e., has clinical laboratory tests that are within the reference ranges or are clinically acceptable per Investigator judgment).
- Participant has a seated systolic blood pressure (SBP) >=90 mm Hg and <=140 mm Hg or a seated diastolic BP (DBP) >=50 mm Hg or <=90 mm Hg.
Key exclusion criteria (39 listed)
- (Applicable to Both Healthy and an Autoimmune Disease Participants Unless Indicated Otherwise)
- Participant has received treatment with LAD191 previously.
- Known hypersensitivity to LAD191 or any of its excipients.
- Hypersensitivity or reaction to a prior biologic (antibody-based) therapy (regardless of indication), that was clinically significant, as per judgment of Investigator.
- History of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, inflammatory, or allergic disease (including drug allergies, any active seizure disorder requiring therapy with antiepileptic drugs, active peptic ulcer disease, gastrointestinal bleeding, chronic gastritis, inflammatory bowel disease or chronic diarrhea, but excluding mild seasonal allergies or stable, well-controlled thyroiditis). Note that participants with thyroid hormone deficiency, hypertension, hyperlipidemia, or diabetes mellitus may be included in Part 3 of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAD191LAD191 SC injection. | Drug | Part 1: LAD191 (Cohort 1), Part 1: LAD191 (Cohort 2), Part 1: LAD191 (Cohort 3), Part 1: LAD191 (Cohort 4), Part 1: LAD191 (Cohort 5), Part 2: LAD191 (Cohort 6), Part 2: LAD191 (Cohort 7), Part 2: LAD191 (Cohort 8), Part 3: LAD191 (Cohort 9) |
| PlaceboMatching placebo SC injection. | Other | Part 1: Placebo, Part 2: Placebo, Part 3: Placebo |
Primary outcome
Part 1: Number of Participants with Adverse Events (AEs) and Severity of AEs
Time frame: Baseline up to Day 73
Part 1: Number of Participants who have Dose-limiting Adverse Reactions
Time frame: Baseline up to Day 73
Part 1: Number of Participants with Clinically Significant Changes from Baseline in Vital Sign Parameter
Time frame: Baseline up to Day 73
Part 1: Number of Participants with Clinically Significant Changes from Baseline in Physical Examination Findings
Time frame: Baseline up to Day 73
Part 1: Number of Participants with Clinically Significant Changes from Baseline in Electrocardiograms (ECGs) Parameters
Time frame: Baseline up to Day 73
Part 1: Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters
Time frame: Baseline up to Day 73
Part 2 and 3: Number of Participants with Adverse Events (AEs) and Severity of AEs
Time frame: Baseline up to Day 94
Part 2 and 3: Number of Participants who have Dose-limiting Adverse Reactions
Time frame: Baseline up to Day 94
Part 2 and 3: Number of Participants with Clinically Significant Changes from Baseline in Vital Sign Parameter
Time frame: Baseline up to Day 94
Part 2 and 3: Number of Participants with Clinically Significant Changes from Baseline in Physical Examination Findings
Time frame: Baseline up to Day 94
Part 2 and 3: Number of Participants with Clinically Significant Changes from Baseline in ECGs Parameters
Time frame: Baseline up to Day 94
Part 2 and 3: Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters
Time frame: Baseline up to Day 94
41 secondary outcomes
Part 1: Maximum Serum Concentration (Cmax) of LAD191
Time frame: Pre-dose, 4 hours and 8 hours post-dose on Days 1, 2, 3, 4, 6, 8, 15, 22, 29, 43, 57 and 71
Part 1: Time to Reach Maximum Serum Concentration (Tmax) of LAD191
Time frame: Pre-dose, 4 hours and 8 hours post-dose on Days 1, 2, 3, 4, 6, 8, 15, 22, 29, 43, 57 and 71
Part 1: Area Under the Serum Concentration-time Curve from Zero to Time of the Last Quantifiable Concentration (AUC0-t) of LAD191
Time frame: Pre-dose, 4 hours and 8 hours post-dose on Days 1, 2, 3, 4, 6, 8, 15, 22, 29, 43, 57 and 71
Part 1: Area Under the Serum Concentration-time Curve from Zero to infinity (AUC0-inf) of LAD191
Time frame: Pre-dose, 4 hours and 8 hours post-dose on Days 1, 2, 3, 4, 6, 8, 15, 22, 29, 43, 57 and 71
Part 1: Elimination Half-life (t½) of LAD191
Time frame: Pre-dose, 4 hours and 8 hours post-dose on Days 1, 2, 3, 4, 6, 8, 15, 22, 29, 43, 57 and 71
Part 1: Apparent Total Serum Clearance (CL/F) of LAD191
Time frame: Pre-dose, 4 hours and 8 hours post-dose on Days 1, 2, 3, 4, 6, 8, 15, 22, 29, 43, 57 and 71
Part 1: Apparent Volume of Distribution Associated with the Terminal Phase (Vd/F) of LAD191
Time frame: Pre-dose, 4 hours and 8 hours post-dose on Days 1, 2, 3, 4, 6, 8, 15, 22, 29, 43, 57 and 71
Part 1: Number of Participants with Positive Anti-drug Antibodies (ADA) and Titer of ADA of LAD191
Time frame: Pre-dose on Day 1; 24 hours post-dose on Days 15; 48 hours post-dose on Days 43 and 71
Part 2: Area Under the Serum Concentration-time Curve from Zero to Time of the Last Quantifiable Concentration (AUC0-t) of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Area Under the Concentration-time Curve within a Dosing Interval (AUCτau) of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Maximum Serum Concentration (Cmax) of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Time to Reach Maximum Serum Concentration (Tmax) of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Minimum Serum Concentrations (Cmin) of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Time to Cmin (tmin) of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Area Under the Serum Concentration-time Curve from Zero to Time of the Last Quantifiable Concentration (AUC0-t) at Steady State of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Area Under the Concentration-time Curve within a Dosing Interval (AUCτau) at Steady State of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Maximum Serum Concentration (Cmax) at Steady State of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Time to Reach Maximum Serum Concentration (Tmax) at Steady State of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Minimum Serum Concentrations (Cmin) at Steady State of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Time to Cmin (tmin) at Steady State of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Apparent Total Serum Clearance (CL/F) of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Apparent Volume of Distribution Associated with the Terminal Phase (Vd/F) of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Elimination Half-life (t½) of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2: Accumulation Ratios Based on AUC (R[AUC]) of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours, 24 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 2 and 3: Number of Participants with Positive ADA and Titer of ADA of LAD191
Time frame: Pre-dose on Days 1, 15, and 29; 4 hours post-dose on Days 43; 48 hours post-dose on 64 and 92
Part 3: Area Under the Serum Concentration-time Curve from Zero to Time of the Last Quantifiable Concentration (AUC0-t) of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Area Under the Concentration-time Curve within a Dosing Interval (AUCτau) of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Maximum Serum Concentration (Cmax) of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Time to Reach Maximum Serum Concentration (Tmax) of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Minimum Serum Concentrations (Cmin) of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Time to Cmin (tmin) of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Area Under the Serum Concentration-time Curve from Zero to Time of the Last Quantifiable Concentration (AUC0-t) at Steady State of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Area Under the Concentration-time Curve within a Dosing Interval (AUCτau) at Steady State of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Maximum Serum Concentration (Cmax) at Steady State of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Time to Reach Maximum Serum Concentration (Tmax) at Steady State of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Minimum Serum Concentrations (Cmin) at Steady State of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Time to Cmin (tmin) at Steady State of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Apparent Total Serum Clearance (CL/F) of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Apparent Volume of Distribution Associated with the Terminal Phase (Vd/F) of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Part 3: Elimination Half-life (t½) of LAD191
Time frame: Pre-dose at Days 1, 8, 15, 22, 29, and 36; At 4 hours and 48 hours post-dose on Days 1, 36, 40, 43, 50, 64, 85 and 92
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Almirall, S.A.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LAD191 in people with Healthy Volunteers and Autoimmune Disease, run by Almirall, S.A. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of Participants with Adverse Events (AEs) and Severity of AEs (time frame: Baseline up to Day 73). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.