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| ID | Type | Description | Link |
|---|---|---|---|
| 75A50124C00033 | Other Grant/Funding Number | BARDA |
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| Name | Class |
|---|---|
| Biomedical Advanced Research and Development Authority | FED |
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The purpose of this study was to investigate the pharmacokinetics and safety of the investigational drug fosmanogepix including its active moiety manogepix following a single dose and multiple doses (by intravenous infusion (IV) or orally) in healthy Chinese adults.
The study consisted of 2 consecutive Parts (Part-1, single-dose part followed by Part-2, multiple-dose part) including a total of 54 subjects (32 subjects in Part-1 and 22 subjects in PART-2) randomized.
Part-1 duration including screening period was up to 64 days including 4 visits at the clinical site and Part-2 duration including screening period was up to 70 days including 5 visits at the clinical site. The study included a total of 4 study sub-groups (Cohorts 1-4) in which fosmanogepix or placebo was administered in different strengths orally or IV.
Subjects were enrolled and randomly assigned to study drug.
During the study, serial blood samples were collected to understand how fosmanogepix was changed and eliminated from the body.
The primary objective of PART-1 (Single-dose) was to evaluate the pharmacokinetic (PK) profile of manogepix (active moiety of fosmanogepix) after single dose administration in healthy adult Chinese subjects.
The primary objective of PART-2 (Multiple-dose) was to evaluate the PK profile of manogepix (active moiety of fosmanogepix) after repeated doses in healthy adult Chinese subjects.
All data analyses are descriptive (no statistical analysis is provided).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-dose Part -1 (Cohort 1, oral) | Experimental | Subjects received fosmanogepix or placebo by oral administration |
|
| Single-dose Part-1 (Cohort 2, IV) | Experimental | Subjects received fosmanogepix or placebo by IV infusion |
|
| Multiple-dose Part-2 (Cohort 3, IV) | Experimental | Subjects received fosmanogepix or placebo as an IV infusion twice 12 hours apart on Day 1 followed by a maintenance daily dose of fosmanogepix or placebo via IV infusion from Day 2 to Day 7 |
|
| Multiple-dose Part-2 (Cohort 4, IV followed by oral) | Experimental | The subjects received fosmanogepix or placebo as an IV infusion twice 12 hours apart on Day 1 followed by an IV maintenance daily dose on Day 2 and Day 3, and then switched to oral administration (of fosmanogepix or placebo) daily from Day 4 to Day 7. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Fosmanogepix | Drug | Oral Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Manogepix in Part-1 | Pharmacokinetic (PK) parameter Cmax for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects | pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose |
| Time to Peak Manogepix Concentration (Tmax) of Manogepix in Part-1 | PK parameter Tmax for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects | pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose |
| Area Under the Plasma Concentration vs. Time Curve for 0-24 Hours (AUC24) of Manogepix in Part-1 | PK parameter AUC 24 for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects | pre-dose, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Manogepix in Part-1 | PK parameter AUClast for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects | pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Manogepix in Part-1 | PK parameter AUC (0 - ∞) for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects |
| Measure | Description | Time Frame |
|---|---|---|
| Fraction of Unbound Manogepix in Plasma in Part 1 | The fraction of unbound manogepix has been assessed after single dose administration (oral / IV) | pre-dose and 3 hours postdose |
| Number of Subjects With Treatment-emergent AE (TEAE) in Part-1 |
Not provided
Main criteria for inclusion and exclusion:
Main exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital, Longchuan North Road | Shanghai | 200237 | China |
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The study was conducted at one site in China
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| ID | Title | Description |
|---|---|---|
| FG000 | Single-dose Part -1 (Cohort 1, Oral 400 mg) | Subjects received 400 mg fosmanogepix by oral administration |
| FG001 | Single-dose Part -1 (Cohort 1, Oral 800 mg) | Subjects received 800 mg fosmanogepix by oral administration |
| FG002 | Single-dose Part-1 (Cohort 2, IV 600 mg) | Subjects received 600 mg fosmanogepix by IV infusion |
| FG003 | Single-dose Part-1 (Cohort 2, IV 1000 mg) | Subjects received 1000 mg fosmanogepix by IV infusion |
| FG004 | Single-dose Part-1 (Placebo) | Subjects received placebo matching the respective Part-1 Cohort treatments |
| FG005 | Multiple-dose Part-2 (Cohort 3, IV 1,000/600 mg) | Subjects received 1,000 mg fosmanogepix as an IV infusion twice 12 hours apart on Day 1 followed by a maintenance daily dose of 600 mg fosmanogepix via IV infusion from Day 2 to Day 7 |
| FG006 | Multiple-dose Part-2 (Cohort 4, IV 1,000/600 mg/Oral 800 mg) | The subjects received 1,000 mg fosmanogepix as an IV infusion twice 12 hours apart on Day 1 followed by an IV 600 mg maintenance daily dose on Day 2 and Day 3, and then switched to 800 mg oral administration daily from Day 4 to Day 7. |
| FG007 | Multiple-dose Part-2 (Placebo) | Subjects received placebo matching the respective Part-2 Cohort treatments |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Demographics and baseline characteristics (Safety set)
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| ID | Title | Description |
|---|---|---|
| BG000 | Single-dose Part -1 (Cohort 1, Oral 400 mg) | Subjects received 400 mg fosmanogepix by oral administration |
| BG001 | Single-dose Part -1 (Cohort 1, Oral 800 mg) | Subjects received 800 mg fosmanogepix by oral administration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Manogepix in Part-1 | Pharmacokinetic (PK) parameter Cmax for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects | PK set included all subjects in the Safety set in Part-1, except for the ones in the placebo group | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose |
|
Overall up to 42 days
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single-dose Part -1 (Cohort 1, Oral 400 mg) | Subjects received 400 mg fosmanogepix by oral administration |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA Version 28.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Kaindl, MD | Basilea Pharmaceutica International Ltd, Allschwil | +41615671505 | thomas.kaindl@basilea.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 18, 2025 | Feb 5, 2026 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 2, 2025 | Feb 5, 2026 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 3, 2025 | Aug 4, 2025 | ICF_000.pdf |
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| IV Fosmanogepix | Drug | IV infusion |
|
| IV placebo | Drug | Matching IV placebo |
|
| oral placebo | Drug | Matching oral placebo |
|
| pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose |
| Maximum Observed Plasma Concentration (Cmax) of Manogepix in Part-2 | PK parameter Cmax after fosmanogepix administration as an IV infusion twice 12 hours apart on Day 1 followed by an IV maintenance daily dose from Day 2 to Day 7 or followed by an IV maintenance dose on Day 2 and Day 3, and then switched to oral administration (of fosmanogepix or placebo) daily from Day 4 to Day 7 | pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240, 360 hours postdose on Day 7 |
| Time to Peak Manogepix Concentration (Tmax) of Manogepix in Part-2 | PK parameter Tmax after fosmanogepix administration as an IV infusion twice 12 hours apart on Day 1 followed by an IV maintenance daily dose on Day 2 and Day 3, and then switched to oral administration (of fosmanogepix or placebo) daily from Day 4 to Day 7 | pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240, 360 hours postdose on Day 7 |
| Area Under the Concentration-time Curve at Steady State Over the Dosing Interval Tau (AUCtau) of Manogepix in Part-2 | PK parameter AUCtau after fosmanogepix administration as an IV infusion twice 12 hours apart on Day 1 followed by an IV maintenance daily dose from Day 2 to Day 7 or followed by an IV maintenance dose on Day 2 and Day 3, and then switched to oral administration (of fosmanogepix or placebo) daily from Day 4 to Day 7 | pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240, 360 hours postdose on Day 7 |
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
| Up to 36 days |
| Number of Subjects With TEAE in Part-2 | A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug | Up to 42 days |
| Did not receive study drug due to safety finding pre-dose |
|
| BG002 | Single-dose Part-1 (Cohort 2, IV 600 mg) | Subjects received 600 mg fosmanogepix by IV infusion |
| BG003 | Single-dose Part-1 (Cohort 2, IV 1000 mg) | Subjects received 1000 mg fosmanogepix by IV infusion |
| BG004 | Single-dose Part-1 (Placebo) | Subjects received placebo matching the respective Part-1 Cohort treatments |
| BG005 | Multiple-dose Part-2 (Cohort 3, IV 1,000/600 mg) | Subjects received 1,000 mg fosmanogepix as an IV infusion twice 12 hours apart on Day 1 followed by a maintenance daily dose of 600 mg fosmanogepix via IV infusion from Day 2 to Day 7 |
| BG006 | Multiple-dose Part-2 (Cohort 4, IV 1,000/600 mg/Oral 800 mg) | The subjects received 1,000 mg fosmanogepix as an IV infusion twice 12 hours apart on Day 1 followed by an IV 600 mg maintenance daily dose on Day 2 and Day 3, and then switched to 800 mg oral administration daily from Day 4 to Day 7. |
| BG007 | Multiple-dose Part-2 (Placebo) | Subjects received placebo matching the respective Part-2 Cohort treatments |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Height (cm) | Mean | Standard Deviation | Cm |
|
| Weight (kg) | Mean | Standard Deviation | Kg |
|
| BMI (kg/m2) | Mean | Standard Deviation | Kg/m2 |
|
Subjects received 800 mg fosmanogepix by oral administration |
| OG002 | Single-dose Part-1 (Cohort 2, IV 600 mg) | Subjects received 600 mg fosmanogepix by IV infusion |
| OG003 | Single-dose Part-1 (Cohort 2, IV 1000 mg) | Subjects received 1000 mg fosmanogepix by IV infusion |
|
|
| Primary | Time to Peak Manogepix Concentration (Tmax) of Manogepix in Part-1 | PK parameter Tmax for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects | PK set included all subjects in the Safety set in Part-1, except for the ones in the placebo group | Posted | Median | Full Range | hour | pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose |
|
|
|
| Primary | Area Under the Plasma Concentration vs. Time Curve for 0-24 Hours (AUC24) of Manogepix in Part-1 | PK parameter AUC 24 for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects | PK set included all subjects in the Safety set in Part-1, except for the ones in the placebo group | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | pre-dose, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose |
|
|
|
| Primary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Manogepix in Part-1 | PK parameter AUClast for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects | PK set included all subjects in the Safety set in Part-1, except for the ones in the placebo group | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose |
|
|
|
| Primary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Manogepix in Part-1 | PK parameter AUC (0 - ∞) for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects | PK set included all subjects in the Safety set in Part-1, except for the ones in the placebo group | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose |
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Manogepix in Part-2 | PK parameter Cmax after fosmanogepix administration as an IV infusion twice 12 hours apart on Day 1 followed by an IV maintenance daily dose from Day 2 to Day 7 or followed by an IV maintenance dose on Day 2 and Day 3, and then switched to oral administration (of fosmanogepix or placebo) daily from Day 4 to Day 7 | PK set included all subjects in the Safety set in Part-2, except for the ones in the placebo group PK and one subject in the IV 1,000/600 mg group, who did not have post-baseline measurable concentration of manogepix | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240, 360 hours postdose on Day 7 |
|
|
|
| Primary | Time to Peak Manogepix Concentration (Tmax) of Manogepix in Part-2 | PK parameter Tmax after fosmanogepix administration as an IV infusion twice 12 hours apart on Day 1 followed by an IV maintenance daily dose on Day 2 and Day 3, and then switched to oral administration (of fosmanogepix or placebo) daily from Day 4 to Day 7 | PK set included all subjects in the Safety set in Part-2, except for the ones in the placebo group PK and one subject in the IV 1,000/600 mg group, who did not have post-baseline measurable concentration of manogepix | Posted | Median | Full Range | hour | pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240, 360 hours postdose on Day 7 |
|
|
|
| Primary | Area Under the Concentration-time Curve at Steady State Over the Dosing Interval Tau (AUCtau) of Manogepix in Part-2 | PK parameter AUCtau after fosmanogepix administration as an IV infusion twice 12 hours apart on Day 1 followed by an IV maintenance daily dose from Day 2 to Day 7 or followed by an IV maintenance dose on Day 2 and Day 3, and then switched to oral administration (of fosmanogepix or placebo) daily from Day 4 to Day 7 | PK set included all subjects in the Safety set in Part-2, except for the ones in the placebo group PK and one subject in the IV 1,000/600 mg group, who did not have post-baseline measurable concentration of manogepix | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240, 360 hours postdose on Day 7 |
|
|
|
| Secondary | Fraction of Unbound Manogepix in Plasma in Part 1 | The fraction of unbound manogepix has been assessed after single dose administration (oral / IV) | PK set included all subjects in the Safety set in Part-1, except for the ones in the placebo group | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage | pre-dose and 3 hours postdose |
|
|
|
| Secondary | Number of Subjects With Treatment-emergent AE (TEAE) in Part-1 | A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug | Safety set consisted of all randomized subjects who had received at least one dose of study drug. Subjects were to be analyzed according to the drug they actually received | Posted | Count of Participants | Participants | Up to 36 days |
|
|
|
| Secondary | Number of Subjects With TEAE in Part-2 | A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug | Safety set consisted of all randomized subjects who had received at least one dose of study drug. Subjects were to be analyzed according to the drug they actually received | Posted | Count of Participants | Participants | Up to 42 days |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | Single-dose Part -1 (Cohort 1, Oral 800 mg) | Subjects received 800 mg fosmanogepix by oral administration | 0 | 6 | 0 | 6 | 3 | 6 |
| EG002 | Single-dose Part-1 (Cohort 2, IV 600 mg) | Subjects received 600 mg fosmanogepix by IV infusion | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | Single-dose Part-1 (Cohort 2, IV 1000 mg) | Subjects received 1000 mg fosmanogepix by IV infusion | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | Single-dose Part-1 (Placebo) | Subjects received placebo matching the respective Part-1 Cohort treatments | 0 | 8 | 0 | 8 | 0 | 8 |
| EG005 | Multiple-dose Part-2 (Cohort 3, IV 1,000/600 mg) | Subjects received 1,000 mg fosmanogepix as an IV infusion twice 12 hours apart on Day 1 followed by a maintenance daily dose of 600 mg fosmanogepix via IV infusion from Day 2 to Day 7 | 0 | 8 | 0 | 8 | 5 | 8 |
| EG006 | Multiple-dose Part-2 (Cohort 4, IV 1,000/600 mg/Oral 800 mg) | The subjects received 1,000 mg fosmanogepix as an IV infusion twice 12 hours apart on Day 1 followed by an IV 600 mg maintenance daily dose on Day 2 and Day 3, and then switched to 800 mg oral administration daily from Day 4 to Day 7. | 0 | 8 | 0 | 8 | 7 | 8 |
| EG007 | Multiple-dose Part-2 (Placebo) | Subjects received placebo matching the respective Part-2 Cohort treatments | 0 | 4 | 0 | 4 | 2 | 4 |
| Creatinine renal clearance decreased | Investigations | MedDRA Version 28.0 | Systematic Assessment |
|
| Electrocardiogram ST segment elevation | Investigations | MedDRA Version 28.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA Version 28.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA Version 28.0 | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA Version 28.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA Version 28.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
|
| Drooling | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
|
| Regurgitation | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 28.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 28.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
|
Not provided
Not provided
| Any treatment-emergent serious adverse event (SAE) |
|
| Any study drug-related TEAE leading to treatment discontinuation |
|
| None TEAE |
|
|
| Any treatment-emergent SAE |
|
| None TEAE |
|