A Study to Assess the Safety of MEB-1170 in Healthy Subjects

NCT05748119 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: MEB-1170-101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To determine the safety and tolerability of single and multiple ascending oral doses of MEB-1170 in healthy subjects. Secondary Objectives:

1. 1.To determine the single and multiple oral dose pharmacokinetic profiles of MEB-1170 and the primary metabolite, M373, in healthy subjects.
2. 2.To determine the effect of food on the pharmacokinetic (PK) profile of a single oral dose of MEB-1170 in healthy subjects.
3. 3.To assess the pharmacodynamic (PD) response following single and multiple oral doses of MEB-1170

Conditions

Pain

Outcome Measures

Primary Outcomes (49)

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for hematology

  Hematology parameters to be tested are: • Hemoglobin (HGB)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for hematology

  Hematology parameters to be tested are: • Hematocrit (HCT)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for hematology

  Hematology parameters to be tested are: • Erythrocytes (RBC)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for hematology

  Hematology parameters to be tested are: • Platelets (PLAT)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for hematology

  Hematology parameters to be tested are: • Leukocytes with differential (including Eosinophils (ESN), Neutrophils (NEUT), Basophils (BASO), Lymphocytes (LYM) and Reticulocytes (RETI)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry

  Biochemistry parameters to be tested are: • C-reactive protein (CRP)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry

  Biochemistry parameters to be tested are: • Urea (U)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry

  Biochemistry parameters to be tested - Creatinine (CREAT)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry

  Biochemistry parameters to be tested - Total Bilirubin (BILI) and Direct Bilirubin (BILIDIR)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry

  Biochemistry parameters to be tested - Urate (URATE)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry

  Biochemistry parameters to be tested - Albumin (ALB)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry

  Biochemistry parameters to be tested - Alkaline Phosphatase (ALP)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry

  Biochemistry parameters to be tested - Creatine phosphokinase (CPK)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry

  Biochemistry parameters to be tested - Troponin 1 (TROP1)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry

  Biochemistry parameters to be tested - Aspartate Aminotransferase (AST)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry

  Biochemistry parameters to be tested - Alanine Aminotransferase (ALT)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry

  Biochemistry parameters to be tested - Gamma- glutamyl transpeptidase (GGT)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single Ascending Doses of MEB-1170 for Fasting SAD and MAD laboratory assessments for blood chemistry

  Biochemistry parameters to be tested - Glucose (GLU) (fasting labs only)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry

  Biochemistry parameters to be tested - Sodium (Na)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry

  Biochemistry parameters to be tested - Potassium (K)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry

  Biochemistry parameters to be tested - Calcium (CA)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry

  Biochemistry parameters to be tested - Chloride (CL)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry

  Biochemistry parameters to be tested - Phosphate (PHOS)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry

  Biochemistry parameters to be tested - Bicarbonate (BICARB)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for urine

  Macroscopic urinalysis parameters to be tested - pH (PH)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for urine

  Macroscopic urinalysis parameters to be tested - Specific Gravity (SPGRAV)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for urine

  Macroscopic urinalysis parameters to be tested - Creatinine (CREATININE)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for urine

  Macroscopic urinalysis parameters to be tested - Protein (PROT)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for urine

  Macroscopic urinalysis parameters to be tested - Ketones (KETONES)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for urine

  Macroscopic urinalysis parameters to be tested - Glucose (GLUC)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for urine

  Macroscopic urinalysis parameters to be tested - Total Bilirubin (BILI)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for urine

  Macroscopic urinalysis parameters to be tested - Occult Blood (OCCBLD)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for urine

  Macroscopic urinalysis parameters to be tested - Nitrite (NITRITE)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for urine

  Macroscopic urinalysis parameters to be tested - Urobilinogen (UROBIL)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for urine

  Macroscopic urinalysis parameters to be tested - Leukocytes (WBC)

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assessed by ECG

  A 12-lead ECG will be taken at the time points delineated in the study schedules. Additional ECG monitoring may be performed at other times if deemed necessary. Note that triplicate ECGs are required during SAD, while single ECGs are required during MAD. Readout QT

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assessed by ECG

  A 12-lead ECG will be taken at the time points delineated in the study schedules. Additional ECG monitoring may be performed at other times if deemed necessary. Note that triplicate ECGs are required during SAD, while single ECGs are required during MAD. Readout QTc

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assessed by ECG

  A 12-lead ECG will be taken at the time points delineated in the study schedules. Additional ECG monitoring may be performed at other times if deemed necessary. Note that triplicate ECGs are required during SAD, while single ECGs are required during MAD. Readout PR

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assessed by ECG

  A 12-lead ECG will be taken at the time points delineated in the study schedules. Additional ECG monitoring may be performed at other times if deemed necessary. Note that triplicate ECGs are required during SAD, while single ECGs are required during MAD. Readout RR

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assessed by ECG

  A 12-lead ECG will be taken at the time points delineated in the study schedules. Additional ECG monitoring may be performed at other times if deemed necessary. Note that triplicate ECGs are required during SAD, while single ECGs are required during MAD. Readout QRS

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assessed by ECG

  A 12-lead ECG will be taken at the time points delineated in the study schedules. Additional ECG monitoring may be performed at other times if deemed necessary. Note that triplicate ECGs are required during SAD, while single ECGs are required during MAD. Readout QTcF

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assessed by ECG

  A 12-lead ECG will be taken at the time points delineated in the study schedules. Additional ECG monitoring may be performed at other times if deemed necessary. Note that triplicate ECGs are required during SAD, while single ECGs are required during MAD. Readout QTcB

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 to assess adverse events

  Occurrence of all adverse events from first dose through end of study treatment and follow-up last visit will be monitored and treated as adverse events.

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 to assess suicidality risk

  Utilize C-SSRS to assess suicidality risks. Performed at screening and in both SAD and MAD

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assess vital signs

  Vital sign of oral body temperature will be measured at the time points specified in the study schedules with subjects resting for at least 5 minutes in a supine position. When the time of vital signs measurement coincides with a blood draw, the vital signs will be taken before the scheduled blood draw where possible while ensuring the blood draw is within the window specified in the protocol.

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assess vital signs

  Vital sign of blood pressure will be measured at the time points specified in the study schedules with subjects resting for at least 5 minutes in a supine position. When the time of vital signs measurement coincides with a blood draw, the vital signs will be taken before the scheduled blood draw where possible while ensuring the blood draw is within the window specified in the protocol.

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assess vital signs

  Vital sign of heart rate will be measured at the time points specified in the study schedules with subjects resting for at least 5 minutes in a supine position. When the time of vital signs measurement coincides with a blood draw, the vital signs will be taken before the scheduled blood draw where possible while ensuring the blood draw is within the window specified in the protocol.

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assess vital signs

  Vital sign of respiratory rate will be measured at the time points specified in the study schedules with subjects resting for at least 5 minutes in a supine position. When the time of vital signs measurement coincides with a blood draw, the vital signs will be taken before the scheduled blood draw where possible while ensuring the blood draw is within the window specified in the protocol.

  Through study completion, approximately 12 months

• Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assess subjects with a physical exam

  Complete physical examinations will be performed by a licensed physician, nurse practitioner or physician's assistant at the time points specified in the study schedules to ensure there are no changes compared to baseline assessment physical exams.

  Through study completion, approximately 12 months

Secondary Outcomes (8)

• To determine the single and multiple oral dose pharmacokinetic profiles of MEB-1170 and the primary metabolite, M373, in healthy subjects - AUC

  Through study completion, approximately 12 months

• To determine the single and multiple oral dose pharmacokinetic profiles of MEB-1170 and the primary metabolite, M373, in healthy subjects - Cmax

  Through study completion, approximately 12 months

• To determine the effect of food on the pharmacokinetic (PK) profile of a single oral dose of MEB-1170 in healthy subjects - AUC

  Through study completion, approximately 12 months

• To determine the effect of food on the pharmacokinetic (PK) profile of a single oral dose of MEB-1170 in healthy subjects - Cmax

  Through study completion, approximately 12 months

• To assess the pharmacodynamic (PD) response of Pupillometry following single and multiple oral doses of MEB-1170

  Through study completion, approximately 12 months

Study Arms (32)

A1a Placebo

PLACEBO COMPARATOR

Single Sentinel Placebo Comparator for 20 mg Dose of MEB-1170

Drug: Placebo

A1a MEB-1170

EXPERIMENTAL

Single MEB-1170 Sentinel 20 mg Dose

Drug: MEB-1170

A1b Placebo

PLACEBO COMPARATOR

Single Placebo comparator for 20 mg dose cohort of MEB-1170

Drug: Placebo

A1b MEB-1170

EXPERIMENTAL

Single MEB-1170 20 mg dose cohort

Drug: MEB-1170

A2a Placebo

PLACEBO COMPARATOR

Single Sentinel Placebo Comparator for 60 mg Dose of MEB-1170

Drug: Placebo

A2a MEB-1170

EXPERIMENTAL

Single MEB-1170 Sentinel 60 mg Dose

Drug: MEB-1170

A2b Placebo

PLACEBO COMPARATOR

Single Placebo comparator for 60 mg dose cohort of MEB-1170

Drug: Placebo

A2b MEB-1170

EXPERIMENTAL

Single MEB-1170 60 mg dose cohort

Drug: MEB-1170

A3a Placebo

PLACEBO COMPARATOR

Single Sentinel Placebo Comparator for 120 mg Dose of MEB-1170

Drug: Placebo

A3a MEB-1170

EXPERIMENTAL

Single MEB-1170 Sentinel 120 mg Dose

Drug: MEB-1170

A3b Placebo

PLACEBO COMPARATOR

Single Placebo comparator for 120 mg dose cohort of MEB-1170

Drug: Placebo

A3b MEB-1170

EXPERIMENTAL

Single MEB-1170 120 mg dose cohort

Drug: MEB-1170

A4a Placebo

PLACEBO COMPARATOR

Single Sentinel Placebo Comparator for 200 mg Dose of MEB-1170

Drug: Placebo

A4a MEB-1170

EXPERIMENTAL

Single MEB-1170 Sentinel 200 mg Dose

Drug: MEB-1170

A4b Placebo

PLACEBO COMPARATOR

Single Placebo comparator for 200 mg dose cohort of MEB-1170

Drug: Placebo

A4b MEB-1170

PLACEBO COMPARATOR

Single MEB-1170 200 mg dose cohort

Drug: MEB-1170

A5a Placebo

PLACEBO COMPARATOR

Single Sentinel Placebo Comparator for 400 mg Dose of MEB-1170

Drug: Placebo

A5a MEB-1170

EXPERIMENTAL

Single MEB-1170 Sentinel 400 mg Dose

Drug: MEB-1170

A5b Placebo

PLACEBO COMPARATOR

Single Placebo comparator for 400 mg dose cohort of MEB-1170

Drug: Placebo

A5b MEB-1170

EXPERIMENTAL

Single MEB-1170 400 mg dose cohort

Drug: MEB-1170

B1 Placebo

PLACEBO COMPARATOR

MAD Placebo 60 mg comparator cohort of MEB-1170

Drug: Placebo

B1 MEB-1170

EXPERIMENTAL

MAD 60 mg MEB-1170 cohort

Drug: MEB-1170

B2 Placebo

PLACEBO COMPARATOR

MAD Placebo 100 mg comparator cohort of MEB-1170

Drug: Placebo

B2 MEB-1170

EXPERIMENTAL

MAD 100 mg MEB-1170 cohort

Drug: MEB-1170

B3 Placebo

PLACEBO COMPARATOR

MAD Placebo 200 mg comparator cohort of MEB-1170

Drug: Placebo

B3 MEB-1170

EXPERIMENTAL

MAD 200 mg MEB-1170 cohort

Drug: MEB-1170

B4 Placebo

PLACEBO COMPARATOR

MAD Placebo 400 mg comparator cohort of MEB-1170

Drug: Placebo

B4 MEB-1170

EXPERIMENTAL

MAD 400 mg MEB-1170 cohort

Drug: MEB-1170

A3a Placebo Fed State

PLACEBO COMPARATOR

Single Sentinel Placebo Comparator for 120 mg Dose of MEB-1170 in Fed State

Drug: Placebo

A3a MEB-1170 Fed State

EXPERIMENTAL

Single Sentinel 120 mg Dose of MEB-1170 in Fed State

Drug: MEB-1170

A3b Placebo Fed State

PLACEBO COMPARATOR

Single Placebo comparator for 120 mg dose cohort of MEB-1170 in Fed State

Drug: Placebo

A3b MEB-1170 Fed State

EXPERIMENTAL

Single MEB-1170 120 mg dose cohort in Fed State

Drug: MEB-1170

Interventions

MEB-1170 DRUG

Depending on the dosage, either 20 mg, 40 mg capsules, or a combination of both

A1a MEB-1170; A1b MEB-1170; A2a MEB-1170; A2b MEB-1170; A3a MEB-1170; A3a MEB-1170 Fed State; A3b MEB-1170; A3b MEB-1170 Fed State; A4a MEB-1170; A4b MEB-1170; A5a MEB-1170; A5b MEB-1170; B1 MEB-1170; B2 MEB-1170; B3 MEB-1170; B4 MEB-1170

Placebo DRUG

Equivalent number and size of capsules containing placebo

A1a Placebo; A1b Placebo; A2a Placebo; A2b Placebo; A3a Placebo; A3a Placebo Fed State; A3b Placebo; A3b Placebo Fed State; A4a Placebo; A4b Placebo; A5a Placebo; A5b Placebo; B1 Placebo; B2 Placebo; B3 Placebo; B4 Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provides written IRB-approved informed consent prior to any study procedures.
• Male or female between 18 and 55 years old (inclusive) at the time of screening.
• In good general health at screening, free from clinically significant unstable medical, surgical or psychiatric illness, at the discretion of the Investigator.
• Subjects have a BMI between ≥ 18.0 and ≤ 32.0 kg/m2 at screening.
• Vital signs (measured in supine position after a 5-minute rest) at screening:
• Systolic blood pressure ≥90 and ≤140 mmHg
• Diastolic blood pressure ≥50 and ≤ 90 mmHg
• Heart rate ≥45 and ≤100 bpm
• Temperature ≥35.5 °C and ≤ 37.5 °C
• Vital signs may be repeated once, within a minimum of 10 minutes of the completion of the last set of vital signs (while maintaining supine position until the repeated set of vital signs are collected), if it is suspected that falsely high or low levels have been obtained.
• Adequate venous access to allow collection of multiple blood samples.
• Negative Covid PCR test upon admission to the CRU.
• a. Subjects in Cohort A3 will need a second COVID test prior to admission the CRU for Period 2.
• No relevant dietary restrictions and willingness to consume standard meals and snacks.
• Willing to comply with all study procedures and requirements

You may not qualify if:

• Pregnant or lactating at screening or baseline or planning to become pregnant (self or partner) at any time during the study, including the specified follow-up period.
• History or presence of malignancy at screening or baseline, with the exception of adequately treated localised skin cancer (basal cell or squamous cell carcinoma) or carcinoma in-situ of the cervix.
• Clinically significant infection within 28 days of the start of dosing, or infections requiring parenteral antibiotics within the 6 months prior to screening.
• Clinically significant surgical procedure within 3 months of screening, at the discretion of the Investigator.
• Currently suffering from clinically significant systemic allergic disease at screening or baseline or has a history of significant drug allergies including a history of anaphylactic reaction; allergic reaction due to any drug which led to significant morbidity.
• Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within 3 months prior to study treatment administration; corticosteroids are permitted at the discretion of the Investigator), or exposure to any significantly immune suppressing drug within 30 days prior to screening or 5 half lives, whichever is longer.
• History or presence at screening or baseline of a condition associated with significant immunosuppression.
• Positive test for hepatitis C (HCV), hepatitis B (HBsAg), COVID, or human immunodeficiency virus (HIV) antibody at screening.
• Symptoms of dysphagia at screening or baseline or known difficulty in swallowing capsules.
• Any condition at screening or baseline (eg, chronic diarrhea, inflammatory bowel disease or prior surgery of the gastrointestinal tract) that would interfere with drug absorption or any disease or condition that is likely to affect drug metabolism or excretion, at the discretion of the Investigator.
• History or presence at screening or baseline of clinically significant cardiac arrhythmia or congenital long QT syndrome.
• QT interval corrected using Fridericia's formula (QTcF) \> 450 msec for males or \>470 msec for females.
• Use of tobacco or nicotine containing products in the previous month prior to dosing or a positive urine cotinine test at Screening or Baseline.
• Lack of willingness to abstain from the consumption of tobacco or nicotine-containing products throughout the duration of the study and until completion of the final Follow-up visit.
• Regular alcohol consumption defined as \> 21 alcohol units per week (where 1 unit = 284 mL of beer, 25 mL of 40% spirit or a 125 mL glass of wine) or the subject is unwilling to abstain from alcohol for 48 h prior to admission and 48 h prior to Follow-up study visit.

Sponsors & Collaborators

• Mebias Discovery, Inc: lead

Study Sites (1)

Labcorp Clinical Research Unit, Inc

Daytona Beach, Florida, 32117, United States

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Barbara Lomeli, MD, CPI

CONTACT

816-516-8565; barbara.lomeli@labcorp.com

Sunu Valasseri, MBBS, MSc, DPM

CONTACT

+44(0)7882654874; s.valasseri@labcorp.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: February 28, 2023
• Study Start: November 15, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: February 28, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)