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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003914-41 | EudraCT Number | ||
| Covance Study Number: 8392356 | Other Identifier | Covance |
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This was a Phase 1, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetics of orally administered GB1211 will be evaluated in healthy adult subjects and adult subjects with indication of suspected Nonalcoholic steatohepatitis (NASH) and liver fibrosis.
The study consisted of 2 parts: a SAD phase (Part A) which enrolled a total of 5 cohorts of healthy subjects and a MAD phase (Part B) which enrolled 2 cohorts of healthy subjects. Two additional cohorts A6 and A7, were added following dose escalation analysis.
The planned optional Part C was to include a multiple-dose cohort of 25 subjects with suspected NASH and liver fibrosis (Cohort C1). However, Part C of the study was not performed as per Sponsor's decision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 - 5 mg GB1211 single dose and Placebo | Experimental | 6 healthy subjects are administered 5 mg of GB1211 capsules orally as a single dose in the fasted state. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. |
|
| A2 - 20 mg GB1211 single dose and Placebo | Experimental | 6 healthy subjects are administered 20 mg of GB1211 capsules orally as a single dose in the fasted state. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. |
|
| A3 - 50 mg GB1211 single dose (food effect cohort) and Placebo | Experimental | 6 healthy subjects are administered 50 mg of GB1211 capsules orally as a single dose. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. Each subject will participate in 2 treatment periods separated by a minimum of 7 days. In Treatment Period 1 doses will be administered in the fasted state, in Treatment Period 2 doses will be administered 30 minutes after the start of a high fat breakfast. Subjects will receive the same treatment in both periods. |
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| A4 - 100 mg GB1211 single dose and Placebo | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GB1211 | Drug | Hard capsules for oral use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With of Adverse Events (AEs) | The number of participants in each arm that report Adverse Events (AEs) | Up to 5-7 days post final dose (Part A: Single dose), Part B: 6-7 weeks |
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Inclusion Criteria:
Subjects for Parts A and B must satisfy all of the following criteria at the Screening visit unless otherwise stated:
Subjects for Parts C must satisfy all of the following criteria at the Screening visit unless otherwise stated:
Exclusion Criteria:
Subjects from Part A & B will be excluded from the study if they satisfy any of the following criteria at the Screening visit unless otherwise stated:
3 (Part A). Any of the following: a. QTcF > 450 msec confirmed by repeat measurement. b. QRS duration > 110 msec confirmed by repeat measurement. c. PR interval > 220 msec confirmed by repeat measurement. d. findings which would make QTc measurements difficult or QTc data uninterpretable. e. history of additional risk factors for torsades de pointes (eg, heart failure, hypokalaemia, family history of long QT syndrome).
3 (Part B). Clinically significant ECG abnormalities or QTcF greater than 450 msec for males and 470 msec for females at either Screening or Day 1 predose, or any prior history of QT abnormality.
4. History of alcoholism or drug/chemical abuse within 1 year prior to Check-in.
5. Positive hepatitis panel and/or positive human immunodeficiency virus (HIV) test.
6. Participation in a clinical study involving administration of an investigational agent or vaccine (new chemical entity) or having received a biological product in the past 90 days prior to dosing.
7. Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, unless deemed acceptable by the Investigator (or designee).
8. Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing, unless deemed acceptable by the Investigator (or designee).
9. Use of tobacco- or nicotine-containing products within 3 months prior to Check-in, or positive cotinine at Screening or Check-in.
10. Receipt of blood products within 2 months prior to Check-in and donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
11. Subject who, in the opinion of the Investigator (or designee), should not participate in this study.
Subjects from Part C will be excluded from the study if they satisfy any of the following criteria at the Screening visit unless otherwise stated:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Ashley Brooks, MBChB | Covance | Principal Investigator |
| Dr Bertil Lindmark MD PHD, Chief Medical Officer | Galecto Biotech AB | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| (For Parts A and B) Covance Clinical Research Unit Ltd | Leeds | LS2 9LH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36914828 | Derived | Aslanis V, Slack RJ, MacKinnon AC, McClinton C, Tantawi S, Gravelle L, Nilsson UJ, Leffler H, Brooks A, Khindri SK, Marshall RP, Pedersen A, Schambye H, Zetterberg F. Safety and pharmacokinetics of GB1211, an oral galectin-3 inhibitor: a single- and multiple-dose first-in-human study in healthy participants. Cancer Chemother Pharmacol. 2023 Mar;91(3):267-280. doi: 10.1007/s00280-023-04513-y. Epub 2023 Mar 13. |
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A total of 78 subjects entered the study and were randomised to treatment, with 56 subjects in Part A and 22 subjects in Part B.
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| ID | Title | Description |
|---|---|---|
| FG000 | A1 - 5 mg GB1211 Single Dose | 6 healthy subjects are administered 5 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use |
| FG001 | A2 - 20 mg GB1211 Single Dose | 6 healthy subjects are administered 20 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use |
| FG002 | A3 - 50 mg GB1211 Single Dose (Food Effect Cohort) | 6 healthy subjects are administered 50 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. Each subject will participate in 2 treatment periods separated by a minimum of 7 days. In Treatment Period 1 doses will be administered in the fasted state, in Treatment Period 2 doses will be administered 30 minutes after the start of a high fat breakfast. Subjects will receive the same treatment in both periods. GB1211: Hard capsules for oral use |
| FG003 | A4 - 100 mg GB1211 Single Dose | 6 healthy subjects are administered 100 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use |
| FG004 | A5 - 200 mg GB1211 Single Dose | 6 healthy subjects are administered 200 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use |
| FG005 | A6 - 50mg GB1211 Single Dose | 6 healthy subjects are administered 50 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis. GB1211: Hard capsules for oral use |
| FG006 | A7 - 400 mg GB1211 Single Dose | 6 healthy subjects are administered 400 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis. GB1211: Hard capsules for oral use |
| FG007 | Part A - Placebo GB1211 | In Part A, 14 subjects will receive placebo in total. Placebo: Hard capsules for oral use |
| FG008 | B1 - GB1211 Multiple Ascending Doses, 50mg BID | GB1211 50 mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule. GB1211: Hard capsules for oral use |
| FG009 | B2 - GB1211 Multiple Ascending Doses, 100mg BID | GB1211 100 mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule. GB1211: Hard capsules for oral use |
| FG010 | Part B - PLacebo GB1211 (BID) | In Part B, 6 subjects will receive placebo in total. Placebo: Hard capsules for oral use |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A1 - 5 mg GB1211 Single Dose | 6 healthy subjects are administered 5 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use |
| 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 | Number of Participants With of Adverse Events (AEs) | The number of participants in each arm that report Adverse Events (AEs) | All subjects in part A and B were included in the safety populations. The safety population will include all subjects who received at least 1 dose of study treatment (GB1211 or placebo). Safety parameters will be listed and summarised using descriptive statistics. No formal statistical analysis of safety data is planned. | Posted | Number | Count of Participants | Up to 5-7 days post final dose (Part A: Single dose), Part B: 6-7 weeks |
|
Up to 5-7 days post final dose (Part A: Single dose), Part B: 6-7 weeks
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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 | Part A - Placebo for GB1211 | In Part A, 14 subjects will receive placebo in total. Placebo: Hard capsules for oral use |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment | TEAEs reported at Part B Placebo group (1AE) and Part B B1 100mg BID group (2AEs) were determined to be drug related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Bertil Lindmark, Chief Medical Officer | Galecto BIotech | +45 70 70 52 10 | info@galecto.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 25, 2019 | Dec 17, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Nov 5, 2018 | Dec 18, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
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Part A: 56 subjects will be studied in 7 cohorts (Cohorts A1 to A7) Part B: 22 subjects will be studied in 2 cohorts (Cohorts B1 to B2)
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6 healthy subjects are administered 100 mg of GB1211 capsules orally as a single dose in the fasted state. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. |
|
| A5 - 200 mg GB1211 single dose and Placebo | Experimental | 6 healthy subjects are administered 200 mg of GB1211 capsules orally as a single dose in the fasted state. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. |
|
| B1 - GB1211 multiple ascending doses, 50mg BID and Placebo | Experimental | GB1211 administered orally twice daily over 10 days. 8 healthy subjects received GB1211 and 3 subjects will receive placebo. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule. |
|
| B2 - GB1211 multiple ascending doses, 100mg BID and Placebo | Experimental | GB1211 administered orally twice daily over 10 days. 8 healthy subjects received GB1211 and 3 subjects will receive placebo. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule.. |
|
| A6 - 50mg GB1211 single dose and Placebo | Experimental | 8 healthy subjects are administered 50 mg (10 x 5mg capsules) or placebo without sentinel dosing. Optional cohort, as was added following dose-escalation analysis. |
|
| A7 - 400 mg GB1211 single dose and Placebo | Experimental | 8 healthy subjects are administered 400 mg (8 x 50mg capsules) or placebo without sentinel dosing. Optional cohort, as was added following dose-escalation analysis. |
|
| Part A - Placebo for GB1211 | Experimental | In Part A - 2 subjects from each arm (A1-A5) will receive placebo. |
|
| Part B - Placebo for GB1211 (BID) | Experimental | Part B - 3 subjects from each arm B1 and B2 will receive placebo. |
|
| Placebo | Drug | Hard capsules for oral use |
|
|
| BG001 |
| A2 - 20 mg GB1211 Single Dose |
6 healthy subjects are administered 20 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use |
| BG002 | A3 - 50 mg GB1211 Single Dose (Food Effect Cohort) | 6 healthy subjects are administered 50 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use |
| BG003 | A4 - 100 mg GB1211 Single Dose | 6 healthy subjects are administered 100 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use |
| BG004 | A5 - 200 mg GB1211 Single Dose | 6 healthy subjects are administered 200 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use |
| BG005 | A6 - 50mg GB1211 Single Dose | 6 healthy subjects are administered 50 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis. GB1211: Hard capsules for oral use |
| BG006 | A7 - 400 mg GB1211 Single Dose | 6 healthy subjects are administered 400 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis. GB1211: Hard capsules for oral use |
| BG007 | Part A - Placebo for GB1211 | In Part A, 14 subjects will receive placebo in total. Placebo: Hard capsules for oral use Placebo: Hard capsules for oral use |
| BG008 | B1 - GB1211 Multiple Ascending Doses, 50mg BID | GB1211 50mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule. GB1211: Hard capsules for oral use |
| BG009 | B2 - GB1211 Multiple Ascending Doses, 100mg BID | GB1211 100mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule. GB1211: Hard capsules for oral use |
| BG010 | Part B - Placebo for GB1211 (BID) | In Part B, 6 subjects will receive placebo in total. Placebo: Hard capsules for oral use Placebo: Hard capsules for oral use |
| BG011 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kilogram |
|
| Height | Mean | Standard Deviation | centimeter |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | A2 - 20 mg GB1211 Single Dose | 6 healthy subjects are administered 20 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use |
| OG002 | A3 - 50 mg GB1211 Single Dose (Food Effect Cohort) | 6 healthy subjects are administered 50 mg of GB1211 capsules orally as a single dose. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. Each subject will participate in 2 treatment periods separated by a minimum of 7 days. In Treatment Period 1 doses will be administered in the fasted state, in Treatment Period 2 doses will be administered 30 minutes after the start of a high fat breakfast. Subjects will receive the same treatment in both periods. GB1211: Hard capsules for oral use |
| OG003 | A4 - 100 mg GB1211 Single Dose | 6 healthy subjects are administered 100 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use |
| OG004 | A5 - 200 mg GB1211 Single Dose | 6 healthy subjects are administered 200 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use |
| OG005 | A6 - 50mg GB1211 Single Dose | 6 healthy subjects are administered 50 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis. GB1211: Hard capsules for oral use |
| OG006 | A7 - 400 mg GB1211 Single Dose | 6 healthy subjects are administered 400 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis. GB1211: Hard capsules for oral use |
| OG007 | Part A - Placebo for GB1211 | In Part A, 14 subjects will receive placebo in total. Placebo: Hard capsules for oral use |
| OG008 | B1 - GB1211 Multiple Ascending Doses, 50mg BID | GB1211 50 mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule. GB1211: Hard capsules for oral use |
| OG009 | B2 - GB1211 Multiple Ascending Doses, 100mg BID | GB1211 100 mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule. GB1211: Hard capsules for oral use |
| OG010 | Part B - Placebo for GB1211 (BID) | In Part B, 6 subjects will receive placebo in total. Placebo: Hard capsules for oral use |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 5 |
| 14 |
| EG001 | Part A - Placebo GB1211 (Fed) | In Part A, 2 subjects will receive placebo in total in a fed state. Placebo: Hard capsules for oral use | 0 | 2 | 0 | 2 | 1 | 2 |
| EG002 | A1 - 5 mg GB1211 Single Dose | 6 healthy subjects are administered 5 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use | 0 | 6 | 0 | 6 | 3 | 6 |
| EG003 | A2 - 20 mg GB1211 Single Dose | 6 healthy subjects are administered 20 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | A3 - 50 mg GB1211 Single Dose (Period 1: Fasted)" and "A3- 50 mg GB1211 Single Dose (Period 2: Fed) | 6 healthy subjects are administered 50 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use | 0 | 6 | 0 | 6 | 1 | 6 |
| EG005 | A6 - 50mg GB1211 Single Dose | 6 healthy subjects are administered 50 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis. GB1211: Hard capsules for oral use | 0 | 6 | 0 | 6 | 1 | 6 |
| EG006 | A3- 50 mg GB1211 Single Dose (Fed) | 6 healthy subjects are administered 50 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis. GB1211: Hard capsules for oral use | 0 | 6 | 0 | 6 | 1 | 6 |
| EG007 | A4 - 100 mg GB1211 Single Dose | 6 healthy subjects are administered 100 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use | 0 | 6 | 0 | 6 | 1 | 6 |
| EG008 | A5 - 200 mg GB1211 Single Dose | 6 healthy subjects are administered 200 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use | 0 | 6 | 0 | 6 | 0 | 6 |
| EG009 | A7 - 400 mg GB1211 Single Dose | 6 healthy subjects are administered 400 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. GB1211: Hard capsules for oral use | 0 | 6 | 0 | 6 | 1 | 6 |
| EG010 | Part B - Placebo for GB1211 (BID) | In Part B, 6 subjects will receive placebo in total. Placebo: Hard capsules for oral use | 0 | 6 | 0 | 6 | 1 | 6 |
| EG011 | B1 - GB1211 Multiple Ascending Doses, 50mg BID | GB1211 50 mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule. GB1211: Hard capsules for oral use | 0 | 8 | 0 | 8 | 4 | 8 |
| EG012 | B2 - GB1211 Multiple Ascending Doses, 100mg BID | GB1211 100mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule. GB1211: Hard capsules for oral use | 0 | 8 | 0 | 8 | 3 | 8 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment | The TEAE was determined to be drug-related |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment | The TEAE was determined to be drug-related |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment | The TEAE was determined to be drug related |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment | The TEAE was determined to be drug related |
|
| Medical device site reaction | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment | The TEAE was determined to be drug-related |
|
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment | The TEAE reported at Part A Placebo group was determined to be drug related. The TEAE reported on 3 subjects from Part B B1 50mg BID group were determined to be drug related |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment | The TEAE was determined to be drug-related |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment | The TEAE was determined to be drug related |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment | The TEAE was determined to be drug related |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment | The TEAE reported to 2 subjects was determined to be tdrug related |
|
| Dysuria | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment | the TEAE was determined to be drug related |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment | the TEAE was determined to be drug related |
|
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |