Prostatic Neoplasms
Conditions
Keywords
Prostate Neoplasm Cancer Carcinoma, Safety Extension
Brief summary
This is a safety extension of up to 12 months of additional treatment with LMIS 50 mg after the subject has completed 12 months of treatment under Protocol FP01C-13-001 and remain eligible for continued treatment with androgen deprivation therapy. Subjects participating in Protocol FP01C-13-001-EX will be followed for safety only.
Detailed description
This is a multi-center, open-label, single-arm safety extension study. After completing 12 months of treatment with LMIS 50 mg under Protocol FP01C-13-001 (with last dose under Protocol FP01C-13-001 approximately 6 months prior to Day 0 or Protocol FP01C-13-001-EX) and providing a written informed consent, subjects will be screened against baseline inclusion/exclusion criteria necessary for study eligibility. Eligible subjects will receive LMIS 50 mg from the prefilled syringes (without dilution or other mixing) in up to two single subcutaneous injections given 6 months apart.
Interventions
DRUGLMIS 50 mg
Subcutaneous injection of 50 mg Leuprolide Mesylate
Sponsors
QPS-Qualitix
Foresee Pharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Complete 12 months of treatment with LMIS 50 mg under Protocol FP01C-13-001. If a subject wishes to enter the Extension study after more than 28 days following his end of study visit for Protocol FP01C-13-001, his serum testosterone level should be repeated at the screening visit to confirm that his castrate-level testosterone has been maintained. 2. Laboratory values * Absolute neutrophil count ≥ 1,500 cells/µL * Platelets≥100,000 cells/µL * Hemoglobin ≥ 10 gm/dL * Total bilirubin ≤ 1.5 × upper limit of normal (ULN) * Aspartate Transaminase (AST/SGOT) ≤ 2.5 × ULN * Alanine Aminotransferase (ALT/SGPT) ≤ 2.5 × ULN * Serum creatinine ≤ 1.5 mg/dL * Lipid profile within acceptable range according to investigator's opinion * Serum glucose within acceptable range according to investigator's opinion * HgbA1c within acceptable range according to investigator's opinion * Clinical chemistries (K, Na, Mg, Ca and P) within acceptable range according to investigator's judgment * Urinalysis within normal range according to the investigator's judgment 3. Agree to use male contraceptive methods during study trial 4. In the Investigator's opinion, the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol 5. All aspects of the protocol explained and written informed consent obtained \*If the patient completed 12 months of treatment with LMIS 50 mg more than 28 days prior to entering the Extension study, the Eastern Cooperative Oncology Group (ECOG), Physical Examination (PE), ECG, laboratory and Prostate Specific Antigen (PSA) tests should be repeated. If the patient has completed 12 months of treatment with LMIS 50 mg under Protocol FP01C-13-001 within the last 28 days, they will be allowed to enter the Extension study without repeating the testosterone measurements, ECG, PE, laboratory and the PSA tests
Exclusion criteria
1. Receipt of chemotherapy, immunotherapy, cryotherapy, radiotherapy, or anti-androgen therapy other than LMIS 50 mg under Protocol FP01C-13-001 for treatment of carcinoma of the prostate during the subject's participation in Protocol FP01C-13-001. Radiation for pain control will be allowed during the study. 2. Receipt of any Luteinizing Hormone-releasing Hormone (LHRH) suppressive therapy within 6 months of Screening Visit other than LMIS 50 mg under Protocol FP01C-13-001 3. Subject has used prohibited treatments as listed in the Section 8.2 during participation in Protocol FP01C-13-001. 4. Any pathological event, clinical adverse event, or any change in the subject's status at the end of FP01C-13-001 giving indication to the investigator that further participation in the study may not be the best interest of the subject 5. Investigator considers that it is no longer feasible for the subject to be included in a study of LMIS 50 mg 6. Subjects with persistent, non-castrate testosterone levels judged by the investigator 7. Uncontrolled intercurrent illness that would jeopardize the subject's safety, interfere with the objectives of the protocol, or limit the subject's compliance with study requirements, as determined by the Investigator in consultation with the Sponsor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | Up to 48 weeks | Evaluate the incidence of adverse events, drug-related adverse events, and serious adverse events |
| Evaluate the Effect of LMIS 50 mg on Cardiovascular Function | Up to 48 weeks | Use 12-lead resting electrocardiograms (ECGs) to evaluate the effect of LMIS 50 mg on cardiovascular function, such as heart rate, RR interval, QRS complex, PR interval, and QT interval. |
| Laboratory Assessments - Hematology | 48 weeks | Hematology assessments performed in this study included hemoglobin, hematocrit, Red Blood Cell (RBC), White Blood Cell (WBC), platelets, neutrophil, eosinophil, basophil, lymphocyte, monocyte, and HbA1c. |
| Laboratory Assessments - Biochemistry | 48 weeks | Biochemical assessments performed in this study included Alanine Aminotransferase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP), total bilirubin, Blood Urea Nitrogen (BUN), serum Cr, potassium, sodium, magnesium, calcium, phosphorus, blood glucose, Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and triglycerides. |
| Laboratory Assessments - Urinalysis | 48 weeks | Urinalysis was performed to assess the safety profile of LMIS 50 mg during the study period, including pH, specific gravity, and the presences of leukocytes, erythrocytes, or protein. |
Countries
United States
Participant flow
Recruitment details
All subjects were males with advanced prostate carcinoma that completed 12 months (48-week) of therapy with Leuprolide Mesylate Injectable Suspension (LMIS) 50 mg under the Protocol FP01C-13-001 and were suitable candidates for continued medical androgen ablation therapy as judged by investigators.
Participants by arm
| Arm | Count |
|---|---|
| LMIS 50 mg All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)
LMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Transferred to another facility | 1 |
| Overall Study | Treating with the prohibited medications | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | LMIS 50 mg |
|---|---|
| Age, Continuous | 75.0 years STANDARD_DEVIATION 7.86 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 4 / 30 |
| serious Total, serious adverse events | 4 / 30 |
Outcome results
Primary
Evaluate the Effect of LMIS 50 mg on Cardiovascular Function
Use 12-lead resting electrocardiograms (ECGs) to evaluate the effect of LMIS 50 mg on cardiovascular function, such as heart rate, RR interval, QRS complex, PR interval, and QT interval.
Time frame: Up to 48 weeks
Population: 8 subjects did not receive the second dose due to drug supply expiration, and 4 subjects due to early termination. Hence, only 18 subjects entered Day 168 (V4). 3 subjects were unable or unwilling to return on Day 336 (V6/EOS) due to early termination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LMIS 50 mg | Evaluate the Effect of LMIS 50 mg on Cardiovascular Function | Overall Interpretation at Screening (V1) | Normal | 4 Participants |
| LMIS 50 mg | Evaluate the Effect of LMIS 50 mg on Cardiovascular Function | Overall Interpretation at Screening (V1) | Abnormal-No clinical significance | 25 Participants |
| LMIS 50 mg | Evaluate the Effect of LMIS 50 mg on Cardiovascular Function | Overall Interpretation on Day 168 (V4) | Normal | 2 Participants |
| LMIS 50 mg | Evaluate the Effect of LMIS 50 mg on Cardiovascular Function | Overall Interpretation on Day 168 (V4) | Abnormal-No clinical significance | 16 Participants |
| LMIS 50 mg | Evaluate the Effect of LMIS 50 mg on Cardiovascular Function | Overall Interpretation on Day 336 (V6/EOS) | Normal | 7 Participants |
| LMIS 50 mg | Evaluate the Effect of LMIS 50 mg on Cardiovascular Function | Overall Interpretation on Day 336 (V6/EOS) | Abnormal-No clinical significance | 20 Participants |
Primary
Laboratory Assessments - Biochemistry
Biochemical assessments performed in this study included Alanine Aminotransferase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP), total bilirubin, Blood Urea Nitrogen (BUN), serum Cr, potassium, sodium, magnesium, calcium, phosphorus, blood glucose, Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and triglycerides.
Time frame: 48 weeks
Population: 8 subjects did not receive the second dose due to drug supply expiration, and 4 subjects due to early termination. Hence, only 18 subjects entered Day 168 (V4). 3 subjects were unable or unwilling to return on Day 336 (V6/EOS) due to early termination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LMIS 50 mg | Laboratory Assessments - Biochemistry | ALT (U/L) at Screening (V1) | Normal | 28 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | ALT (U/L) at Screening (V1) | Abnormal - No clinical significance | 2 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | ALT (U/L) on Day 336 (V6/EOS) | Normal | 26 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | ALT (U/L) on Day 336 (V6/EOS) | Abnormal - No clinical significance | 1 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | ALP (U/L) on Day 168 (V4) | Normal | 10 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | BUN (mg/dL) at Screening (V1) | Normal | 21 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | BUN (mg/dL) at Screening (V1) | Abnormal - No clinical significance | 9 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | HDL (mg/dL) on Day 168 (V4) | Normal | 12 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Blood glucose (mg/dL) at Screening (V1) | Normal | 22 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Triglycerides(mg/dL) at Screening (V1) | Normal | 17 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Triglycerides(mg/dL) at Screening (V1) | Abnormal - No clinical significance | 13 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | ALT (U/L) at Screening (V1) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | ALT (U/L) on Day 168 (V4) | Normal | 17 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | ALT (U/L) on Day 168 (V4) | Abnormal - No clinical significance | 1 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | ALT (U/L) on Day 168 (V4) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | ALT (U/L) on Day 336 (V6/EOS) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | AST (U/L) at Screening (V1) | Normal | 29 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | AST (U/L) at Screening (V1) | Abnormal - No clinical significance | 1 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | AST (U/L) at Screening (V1) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | AST (U/L) on Day 168 (V4) | Normal | 16 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | AST (U/L) on Day 168 (V4) | Abnormal - No clinical significance | 2 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | AST (U/L) on Day 168 (V4) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | AST (U/L) on Day 336 (V6/EOS) | Normal | 25 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | AST (U/L) on Day 336 (V6/EOS) | Abnormal - No clinical significance | 2 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | AST (U/L) on Day 336 (V6/EOS) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | ALP (U/L) at Screening (V1) | Normal | 26 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | ALP (U/L) at Screening (V1) | Abnormal - No clinical significance | 3 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | ALP (U/L) at Screening (V1) | Abnormal - Clinical significance | 1 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | ALP (U/L) on Day 168 (V4) | Abnormal - No clinical significance | 8 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | ALP (U/L) on Day 168 (V4) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | ALP (U/L) on Day 336 (V6/EOS) | Normal | 17 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | ALP (U/L) on Day 336 (V6/EOS) | Abnormal - No clinical significance | 10 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | ALP (U/L) on Day 336 (V6/EOS) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Total bilirubin(mg/dL) at Screening (V1) | Normal | 30 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Total bilirubin(mg/dL) at Screening (V1) | Abnormal - No clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Total bilirubin(mg/dL) at Screening (V1) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Total bilirubin(mg/dL) on Day 168 (V4) | Normal | 18 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Total bilirubin(mg/dL) on Day 168 (V4) | Abnormal - No clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Total bilirubin(mg/dL) on Day 168 (V4) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Total bilirubin(mg/dL) on Day 336 (V6/EOS) | Normal | 27 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Total bilirubin(mg/dL) on Day 336 (V6/EOS) | Abnormal - No clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Total bilirubin(mg/dL) on Day 336 (V6/EOS) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | BUN (mg/dL) at Screening (V1) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | BUN (mg/dL) on Day 168 (V4) | Normal | 9 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | BUN (mg/dL) on Day 168 (V4) | Abnormal - No clinical significance | 9 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | BUN (mg/dL) on Day 168 (V4) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | BUN (mg/dL) on Day 336 (V6/EOS) | Normal | 15 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | BUN (mg/dL) on Day 336 (V6/EOS) | Abnormal - No clinical significance | 12 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | BUN (mg/dL) on Day 336 (V6/EOS) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Serum Cr. (mg/dL) at Screening (V1) | Normal | 27 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Serum Cr. (mg/dL) at Screening (V1) | Abnormal - No clinical significance | 3 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Serum Cr. (mg/dL) at Screening (V1) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Serum Cr. (mg/dL) on Day 168 (V4) | Normal | 15 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Serum Cr. (mg/dL) on Day 168 (V4) | Abnormal - No clinical significance | 3 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Serum Cr. (mg/dL) on Day 168 (V4) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Serum Cr. (mg/dL) on Day 336 (V6/EOS) | Normal | 24 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Serum Cr. (mg/dL) on Day 336 (V6/EOS) | Abnormal - No clinical significance | 3 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Serum Cr. (mg/dL) on Day 336 (V6/EOS) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Potassium (mEq/L) at Screening (V1) | Normal | 28 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Potassium (mEq/L) at Screening (V1) | Abnormal - No clinical significance | 2 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Potassium (mEq/L) at Screening (V1) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Potassium (mEq/L) on Day 168 (V4) | Normal | 18 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Potassium (mEq/L) on Day 168 (V4) | Abnormal - No clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Potassium (mEq/L) on Day 168 (V4) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Potassium (mEq/L) on Day 336 (V6/EOS) | Normal | 26 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Potassium (mEq/L) on Day 336 (V6/EOS) | Abnormal - No clinical significance | 1 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Potassium (mEq/L) on Day 336 (V6/EOS) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Sodium (mEq/L) at Screening (V1) | Normal | 30 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Sodium (mEq/L) at Screening (V1) | Abnormal - No clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Sodium (mEq/L) at Screening (V1) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Magnesium (mg/dL) on Day 336 (V6/EOS) | Normal | 23 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Sodium (mEq/L) on Day 168 (V4) | Normal | 17 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Sodium (mEq/L) on Day 168 (V4) | Abnormal - No clinical significance | 1 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Sodium (mEq/L) on Day 168 (V4) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Sodium (mEq/L) on Day 336 (V6/EOS) | Normal | 26 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Sodium (mEq/L) on Day 336 (V6/EOS) | Abnormal - No clinical significance | 1 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Sodium (mEq/L) on Day 336 (V6/EOS) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Magnesium (mg/dL) at Screening (V1) | Normal | 26 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Magnesium (mg/dL) at Screening (V1) | Abnormal - No clinical significance | 4 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Magnesium (mg/dL) at Screening (V1) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Magnesium (mg/dL) on Day 168 (V4) | Normal | 14 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Magnesium (mg/dL) on Day 168 (V4) | Abnormal - No clinical significance | 4 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Magnesium (mg/dL) on Day 168 (V4) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Magnesium (mg/dL) on Day 336 (V6/EOS) | Abnormal - No clinical significance | 4 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Magnesium (mg/dL) on Day 336 (V6/EOS) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Calcium (mg/dL) at Screening (V1) | Normal | 29 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Calcium (mg/dL) at Screening (V1) | Abnormal - No clinical significance | 1 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Calcium (mg/dL) at Screening (V1) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Calcium (mg/dL) on Day 168 (V4) | Normal | 17 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Calcium (mg/dL) on Day 168 (V4) | Abnormal - No clinical significance | 1 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Calcium (mg/dL) on Day 168 (V4) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Calcium (mg/dL) on Day 336 (V6/EOS) | Normal | 25 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Calcium (mg/dL) on Day 336 (V6/EOS) | Abnormal - No clinical significance | 2 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Calcium (mg/dL) on Day 336 (V6/EOS) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Phosphorus (mg/dL) at Screening (V1) | Normal | 29 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Phosphorus (mg/dL) at Screening (V1) | Abnormal - No clinical significance | 1 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Phosphorus (mg/dL) at Screening (V1) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Phosphorus (mg/dL) on Day 168 (V4) | Normal | 16 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Phosphorus (mg/dL) on Day 168 (V4) | Abnormal - No clinical significance | 2 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Phosphorus (mg/dL) on Day 168 (V4) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Phosphorus (mg/dL) on Day 336 (V6/EOS) | Normal | 25 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Phosphorus (mg/dL) on Day 336 (V6/EOS) | Abnormal - No clinical significance | 2 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Phosphorus (mg/dL) on Day 336 (V6/EOS) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Blood glucose (mg/dL) at Screening (V1) | Abnormal - No clinical significance | 8 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Blood glucose (mg/dL) at Screening (V1) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Blood glucose (mg/dL) on Day 168 (V4) | Normal | 13 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Blood glucose (mg/dL) on Day 168 (V4) | Abnormal - No clinical significance | 5 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Blood glucose (mg/dL) on Day 168 (V4) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Blood glucose (mg/dL) on Day 336 (V6/EOS) | Normal | 14 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Blood glucose (mg/dL) on Day 336 (V6/EOS) | Abnormal - No clinical significance | 12 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Blood glucose (mg/dL) on Day 336 (V6/EOS) | Abnormal - Clinical significance | 1 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | LDL (mg/dL) at Screening (V1) | Normal | 28 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | LDL (mg/dL) at Screening (V1) | Abnormal - No clinical significance | 1 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | LDL (mg/dL) at Screening (V1) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | LDL (mg/dL) on Day 168 (V4) | Normal | 13 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | LDL (mg/dL) on Day 168 (V4) | Abnormal - No clinical significance | 5 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | HDL (mg/dL) on Day 168 (V4) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | LDL (mg/dL) on Day 168 (V4) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | LDL (mg/dL) on Day 336 (V6/EOS) | Normal | 19 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | LDL (mg/dL) on Day 336 (V6/EOS) | Abnormal - No clinical significance | 7 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | LDL (mg/dL) on Day 336 (V6/EOS) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | HDL (mg/dL) at Screening (V1) | Normal | 21 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | HDL (mg/dL) at Screening (V1) | Abnormal - No clinical significance | 9 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | HDL (mg/dL) at Screening (V1) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | HDL (mg/dL) on Day 168 (V4) | Abnormal - No clinical significance | 6 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | HDL (mg/dL) on Day 336 (V6/EOS) | Normal | 21 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | HDL (mg/dL) on Day 336 (V6/EOS) | Abnormal - No clinical significance | 6 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | HDL (mg/dL) on Day 336 (V6/EOS) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Triglycerides(mg/dL) at Screening (V1) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Triglycerides(mg/dL) on Day 168 (V4) | Normal | 6 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Triglycerides(mg/dL) on Day 168 (V4) | Abnormal - No clinical significance | 12 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Triglycerides(mg/dL) on Day 168 (V4) | Abnormal - Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Triglycerides(mg/dL) on Day 336 (V6/EOS) | Normal | 13 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Triglycerides(mg/dL) on Day 336 (V6/EOS) | Abnormal - No clinical significance | 14 Participants |
| LMIS 50 mg | Laboratory Assessments - Biochemistry | Triglycerides(mg/dL) on Day 336 (V6/EOS) | Abnormal - Clinical significance | 0 Participants |
Primary
Laboratory Assessments - Hematology
Hematology assessments performed in this study included hemoglobin, hematocrit, Red Blood Cell (RBC), White Blood Cell (WBC), platelets, neutrophil, eosinophil, basophil, lymphocyte, monocyte, and HbA1c.
Time frame: 48 weeks
Population: 8 subjects did not receive the second dose due to drug supply expiration, and 4 subjects due to early termination. Hence, only 18 subjects entered Day 168 (V4). 3 subjects were unable or unwilling to return on Day 336 (V6/EOS) due to early termination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LMIS 50 mg | Laboratory Assessments - Hematology | Hemoglobin (gm/dL) on Day 336 (V6/EOS) | Normal | 13 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Hemoglobin (gm/dL) on Day 336 (V6/EOS) | Abnormal-No clinical significance | 14 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Hematocrit (%) on Day 168 (V4) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Hematocrit (%) on Day 336 (V6/EOS) | Normal | 7 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | RBC (x10.e6/uL) at Screening (V1) | Normal | 15 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | RBC (x10.e6/uL) at Screening (V1) | Abnormal-No clinical significance | 15 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | RBC (x10.e6/uL) at Screening (V1) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | RBC (x10.e6/uL) on Day 168 (V4) | Normal | 2 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | RBC (x10.e6/uL) on Day 168 (V4) | Abnormal-No clinical significance | 16 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Basophils (%) on Day 168 (V4) | Normal | 16 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Monocytes (%) on Day 168 (V4) | Abnormal-No clinical significance | 2 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | HgbA1c (%) at Screening (V1) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | HgbA1c (%) on Day 336 (V6/EOS) | Normal | 14 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | HgbA1c (%) on Day 336 (V6/EOS) | Abnormal-No clinical significance | 10 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | HgbA1c (%) on Day 336 (V6/EOS) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Hemoglobin (gm/dL) at Screening (V1) | Normal | 17 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Hemoglobin (gm/dL) at Screening (V1) | Abnormal-No clinical significance | 13 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Hemoglobin (gm/dL) at Screening (V1) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Hemoglobin (gm/dL) on Day 168 (V4) | Normal | 9 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Hemoglobin (gm/dL) on Day 168 (V4) | Abnormal-No clinical significance | 9 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Hemoglobin (gm/dL) on Day 168 (V4) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Hemoglobin (gm/dL) on Day 336 (V6/EOS) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Hematocrit (%) at Screening (V1) | Normal | 18 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Hematocrit (%) at Screening (V1) | Abnormal-No clinical significance | 12 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Hematocrit (%) at Screening (V1) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Hematocrit (%) on Day 168 (V4) | Normal | 4 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Hematocrit (%) on Day 168 (V4) | Abnormal-No clinical significance | 14 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Hematocrit (%) on Day 336 (V6/EOS) | Abnormal-No clinical significance | 20 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Hematocrit (%) on Day 336 (V6/EOS) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | RBC (x10.e6/uL) on Day 168 (V4) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | RBC (x10.e6/uL) on Day 336 (V6/EOS) | Normal | 6 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | RBC (x10.e6/uL) on Day 336 (V6/EOS) | Abnormal-No clinical significance | 21 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | RBC (x10.e6/uL) on Day 336 (V6/EOS) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | WBC (x10.e3/uL) at Screening (V1) | Normal | 26 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | WBC (x10.e3/uL) at Screening (V1) | Abnormal-No clinical significance | 4 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | WBC (x10.e3/uL) at Screening (V1) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | WBC (x10.e3/uL) on Day 168 (V4) | Normal | 18 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | WBC (x10.e3/uL) on Day 168 (V4) | Abnormal-No clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | WBC (x10.e3/uL) on Day 168 (V4) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | WBC (x10.e3/uL) on Day 336 (V6/EOS) | Normal | 22 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | WBC (x10.e3/uL) on Day 336 (V6/EOS) | Abnormal-No clinical significance | 5 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | WBC (x10.e3/uL) on Day 336 (V6/EOS) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Platelets (x10.e3/uL) at Screening (V1) | Normal | 27 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Platelets (x10.e3/uL) at Screening (V1) | Abnormal-No clinical significance | 3 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Platelets (x10.e3/uL) at Screening (V1) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Platelets (x10.e3/uL) on Day 168 (V4) | Normal | 14 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Platelets (x10.e3/uL) on Day 168 (V4) | Abnormal-No clinical significance | 4 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Platelets (x10.e3/uL) on Day 168 (V4) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Platelets (x10.e3/uL) on Day 336 (V6/EOS) | Normal | 23 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Platelets (x10.e3/uL) on Day 336 (V6/EOS) | Abnormal-No clinical significance | 4 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Platelets (x10.e3/uL) on Day 336 (V6/EOS) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Neutrophils(%) at Screening (V1) | Normal | 28 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Neutrophils(%) at Screening (V1) | Abnormal-No clinical significance | 2 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Neutrophils(%) at Screening (V1) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Neutrophils(%) on Day 168 (V4) | Normal | 15 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Neutrophils(%) on Day 168 (V4) | Abnormal-No clinical significance | 2 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Neutrophils(%) on Day 168 (V4) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Neutrophils(%) on Day 336 (V6/EOS) | Normal | 22 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Neutrophils(%) on Day 336 (V6/EOS) | Abnormal-No clinical significance | 4 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Neutrophils(%) on Day 336 (V6/EOS) | Abnormal-Clinical significance | 1 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Eosinophils(%) at Screening (V1) | Normal | 25 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Eosinophils(%) at Screening (V1) | Abnormal-No clinical significance | 5 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Eosinophils(%) at Screening (V1) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Eosinophils(%) on Day 168 (V4) | Normal | 15 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Eosinophils(%) on Day 168 (V4) | Abnormal-No clinical significance | 2 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Eosinophils(%) on Day 168 (V4) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Eosinophils(%) on Day 336 (V6/EOS) | Normal | 20 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Eosinophils(%) on Day 336 (V6/EOS) | Abnormal-No clinical significance | 7 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Eosinophils(%) on Day 336 (V6/EOS) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Basophils (%) at Screening (V1) | Normal | 30 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Basophils (%) at Screening (V1) | Abnormal-No clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Basophils (%) at Screening (V1) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Basophils (%) on Day 168 (V4) | Abnormal-No clinical significance | 1 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Basophils (%) on Day 168 (V4) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Basophils (%) on Day 336 (V6/EOS) | Normal | 27 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Basophils (%) on Day 336 (V6/EOS) | Abnormal-No clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Basophils (%) on Day 336 (V6/EOS) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Lymphocytes (%) at Screening (V1) | Normal | 28 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Lymphocytes (%) at Screening (V1) | Abnormal-No clinical significance | 2 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Lymphocytes (%) at Screening (V1) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Lymphocytes (%) on Day 168 (V4) | Normal | 14 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Lymphocytes (%) on Day 168 (V4) | Abnormal-No clinical significance | 3 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Lymphocytes (%) on Day 168 (V4) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Lymphocytes (%) on Day 336 (V6/EOS) | Normal | 21 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Lymphocytes (%) on Day 336 (V6/EOS) | Abnormal-No clinical significance | 6 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Lymphocytes (%) on Day 336 (V6/EOS) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Monocytes (%) at Screening (V1) | Normal | 26 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Monocytes (%) at Screening (V1) | Abnormal-No clinical significance | 4 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Monocytes (%) at Screening (V1) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Monocytes (%) on Day 168 (V4) | Normal | 15 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Monocytes (%) on Day 168 (V4) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Monocytes (%) on Day 336 (V6/EOS) | Normal | 24 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Monocytes (%) on Day 336 (V6/EOS) | Abnormal-No clinical significance | 3 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | Monocytes (%) on Day 336 (V6/EOS) | Abnormal-Clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | HgbA1c (%) at Screening (V1) | Normal | 22 Participants |
| LMIS 50 mg | Laboratory Assessments - Hematology | HgbA1c (%) at Screening (V1) | Abnormal-No clinical significance | 8 Participants |
Primary
Laboratory Assessments - Urinalysis
Urinalysis was performed to assess the safety profile of LMIS 50 mg during the study period, including pH, specific gravity, and the presences of leukocytes, erythrocytes, or protein.
Time frame: 48 weeks
Population: 8 subjects did not receive the second dose due to drug supply expiration, and 4 subjects due to early termination. Hence, only 18 subjects entered Day 168 (V4). 3 subjects were unable or unwilling to return on Day 336 (V6/EOS) due to early termination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LMIS 50 mg | Laboratory Assessments - Urinalysis | pH at Screening (V1) | Normal | 30 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | pH at Screening (V1) | Abnormal - No clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | pH on Day 168 (V4) | Normal | 18 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | pH on Day 168 (V4) | Abnormal - No clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | pH on Day 336 (V6/EOS) | Normal | 27 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | pH on Day 336 (V6/EOS) | Abnormal - No clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Specific gravity at Screening (V1) | Normal | 30 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Specific gravity at Screening (V1) | Abnormal - No clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Specific gravity on Day 168 (V4) | Normal | 18 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Specific gravity on Day 168 (V4) | Abnormal - No clinical significance | 0 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Specific gravity on Day 336 (V6/EOS) | Normal | 26 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Specific gravity on Day 336 (V6/EOS) | Abnormal - No clinical significance | 1 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Leukocyte at Screening (V1) | Normal | 27 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Leukocyte at Screening (V1) | Abnormal - No clinical significance | 3 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Leukocyte on Day 168 (V4) | Normal | 16 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Leukocyte on Day 168 (V4) | Abnormal - No clinical significance | 2 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Leukocyte on Day 336 (V6/EOS) | Normal | 23 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Leukocyte on Day 336 (V6/EOS) | Abnormal - No clinical significance | 4 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Erythrocyte at Screening (V1) | Normal | 28 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Erythrocyte at Screening (V1) | Abnormal - No clinical significance | 2 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Erythrocyte on Day 168 (V4) | Normal | 17 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Erythrocyte on Day 168 (V4) | Abnormal - No clinical significance | 1 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Erythrocyte on Day 336 (V6/EOS) | Normal | 25 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Erythrocyte on Day 336 (V6/EOS) | Abnormal - No clinical significance | 2 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Protein at Screening (V1) | Normal | 24 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Protein at Screening (V1) | Abnormal - No clinical significance | 6 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Protein on Day 168 (V4) | Normal | 17 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Protein on Day 168 (V4) | Abnormal - No clinical significance | 1 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Protein on Day 336 (V6/EOS) | Normal | 23 Participants |
| LMIS 50 mg | Laboratory Assessments - Urinalysis | Protein on Day 336 (V6/EOS) | Abnormal - No clinical significance | 4 Participants |
Primary
Number of Participants With Adverse Events
Evaluate the incidence of adverse events, drug-related adverse events, and serious adverse events
Time frame: Up to 48 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LMIS 50 mg | Number of Participants With Adverse Events | TEAE | 12 Participants |
| LMIS 50 mg | Number of Participants With Adverse Events | Drug-related AE | 1 Participants |
| LMIS 50 mg | Number of Participants With Adverse Events | Serious Adverse Event (SAE) | 4 Participants |