Safety and TolerabilityPhase 1NCT03809052
A First in Human Study to Evaluate the Safety, Tolerability and PK of GB1211 in Healthy Subjects
A Phase 1 study testing GB1211 in people with Safety and Tolerability, run by Galecto Biotech AB at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Tolerability
- What is being tested?
- GB1211
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jan 2019to 25 Jun 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects for Parts A and B must satisfy all of the following criteria at the Screening visit unless otherwise stated:
- Males or females, of any race, between 18 and 55 years of age (60 years for Part B), inclusive.
- Body mass index (BMI) of 18.0 to 32.0 kg/m^2 (inclusive) with a minimum body weight of 50 kg.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed further in the protocol.
- Male subjects must agree to refrain from sperm donation and females should refrain from ova donation from the date of Check-in (Day -1) until 90 days after the Follow-up visit.
Show all 17Show fewer
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
- Subjects for Parts C must satisfy all of the following criteria at the Screening visit unless otherwise stated:
- Males or females, of any race, between 18 and 60 years of age, inclusive.
- Body mass index (BMI) of ≥ 25.0 and ≤ 38.0 kg/m^2.
- Documented history of fatty liver within the last 24 weeks by one of the following: magnetic resonance imaging (MRI) suggesting liver fat ≥ 8%, ultrasound (US) indicating fatty liver, or Fibroscan Controlled Attenuation Parameter (CAP) > 270 dB/m. In subjects without a documented history of fatty liver, a Fibroscan CAP or US can be performed at Screening. Subjects with Fibroscan CAP > 270 dB/m or US indicating fatty liver are eligible.
- Metabolic syndrome (Adult Treatment Panel III definition) or T2DM (defined as stable diabetes with glycosylated haemoglobin [HbA1c] ≤ 9.5%).
- Alanine aminotransferase (ALT) ≥ 20 U/L for females and ≥ 30 U/L for males at Screening.
- Fibroscan ≥ 7 KPa and < 13 KPa, or Fibrosis-4 (FIB-4) index ≥ 1.1 and <3.25.
- Females of nonchildbearing potential defined as permanently sterile (ie, due to hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy) or postmenopausal (defined as at least 12 months postcessation of menses without an alternative medical cause and follicle-stimulating hormone [FSH] level ≥ 40 mIU/mL). Males will agree to use contraception as detailed in protocol.
- Male subjects must agree to refrain from sperm donation and females should refrain from ova donation from the date of Check-in (Day -1) until 90 days after the Follow-up visit.
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Who cannot join
- 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:
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
- 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.
Show all 29Show fewer
- 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:
- If diabetic and diabetes is other than T2DM.
- Subjects, who have had bariatric surgery of any kind or, in the opinion of the Investigator, have experienced a clinically significant change in body weight within the 3 months prior to Screening.
- History of any known serious disease (such as cancer, except skin basocellular carcinomas, major infection, clinically significant gastrointestinal disorder, major autoimmune disease) or other disease which in the Investigator's opinion would exclude the patient from the study.
- The following clinical laboratory results at Screening: -Total Bilirubin > 2 × ULN, ALT > 155 U/L for females and > 185 U/L for males, AST > 155 U/L for females and > 200 U/L for males
- Other abnormal clinical laboratory values that are considered clinically significant for this population.
- 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.
- History of alcoholism or drug/chemical abuse within 1 year prior to Check-in.
- Alcohol consumption of > 14 units per week for males and for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
- Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at Screening or Check-in.
- Positive hepatitis panel and/or positive HIV test .
- A creatinine clearance of less than 50 mL/min (as calculated by Cockcroft-Gault equation) or estimated glomerular filtration rate (eGFR) < 60 mL/[min*1.73 m²] at Screening.
- Subject taking any antidiabetic medications, with the exception of metformin, sulfonylureas, gliptins, and sodium/glucose co-transporter 2 inhibitors, within 3 months prior to Screening.
- Use of any of the following non-permitted medication within 6 months prior to Screening: amiodarone, bile salt chelators, methotrexate, pharmacological doses of systemic corticosteroids for at least 2 consecutive weeks, or any other medications known to affect liver function.
- Have previously completed or withdrawn from this study investigating GB1211, and have previously received the investigational product.
- Subject who, in the opinion of the Investigator (or designee), should not participate in this study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
(For Parts A and B) Covance Clinical Research Unit Ltd
Leeds, LS2 9LH
About this study
Official title: GB1211 - A Randomised, Double-Blind, Placebo-Controlled, First-In-Human, Study of Orally Administered GB1211 to Evaluate the Safety, Tolerability, and PK of Single Ascending Doses (SAD) and Multiple Ascending Doses (MAD) in Healthy Subjects
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.
Read the detailed description
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.
- Conditions
- Safety and Tolerability
- Being tested
- GB1211, Placebo
- Keywords
- GB1211, Phase 1, First Time in Human, Safety, Tolerability, Pharmacokinetics, Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), Healthy Volunteers, Nonalcoholic Steatohepatitis (NASH), Liver Fibrosis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB1211Drug
Hard capsules for oral use
PlaceboDrug
Also called GB1211
Hard capsules for oral use
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: GB1211 |
| 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. Receives: Drug: GB1211 |
| 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. Receives: Drug: GB1211 |
| A4 - 100 mg GB1211 single dose and Placebo | Experimental | 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. Receives: Drug: GB1211 |
| 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. Receives: Drug: GB1211 |
| 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. Receives: Drug: GB1211 |
| 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.. Receives: Drug: GB1211 |
| 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. Receives: Drug: GB1211 |
| 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. Receives: Drug: GB1211 |
| Part A - Placebo for GB1211 | Experimental | In Part A - 2 subjects from each arm (A1-A5) will receive placebo. Receives: Drug: Placebo |
| Part B - Placebo for GB1211 (BID) | Experimental | Part B - 3 subjects from each arm B1 and B2 will receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With of Adverse Events (AEs)
The number of participants in each arm that report Adverse Events (AEs)
Measured: Up to 5-7 days post final dose (Part A: Single dose), Part B: 6-7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start14 Jan 2019
- Primary completion25 Jun 2019
- Study completion25 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Safety and TolerabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galecto Biotech AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Ashley Brooks, MBChB, Principal investigator, CovanceDr Bertil Lindmark MD PHD, Chief Medical Officer, Study chair, Galecto Biotech AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809052
- Sponsor's protocol ID
- GB1211-001
- Other IDs
- 2018-003914-41, Covance Study Number: 8392356, 2018
- Status last verified
- Jan 2019
- First submitted
- 7 Dec 2018
- Last updated
- 17 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36914828
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GB1211 - A Randomised, Double-Blind, Placebo-Controlled, First-In-Human, Study of Orally Administered GB1211 to Evaluate the Safety, Tolerability, and PK of Single Ascending Doses (SAD) and Multiple Ascending Doses (MAD) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03809052
- Acronym / sponsor ID
- GB1211-001
- Conditions
- Safety and Tolerability
- Keywords
- GB1211, Phase 1, First Time in Human, Safety, Tolerability, Pharmacokinetics, Single Ascending Dose (SAD), Multiple Ascending Dose (MAD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Galecto Biotech ABIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 18 Jan 2019 (actual)
- Results
- Posted 23 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| A1 - 5 mg GB1211 single dose and Placebo | Experimental | Drug: GB12116 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 | Drug: GB12116 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 | Drug: GB12116 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. |
| A4 - 100 mg GB1211 single dose and Placebo | Experimental | Drug: GB12116 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 | Drug: GB12116 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 | Drug: GB1211GB1211 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 | Drug: GB1211GB1211 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 | Drug: GB12118 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 | Drug: GB12118 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 | Drug: PlaceboIn Part A - 2 subjects from each arm (A1-A5) will receive placebo. |
| Part B - Placebo for GB1211 (BID) | Experimental | Drug: PlaceboPart B - 3 subjects from each arm B1 and B2 will receive placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Subjects for Parts A and B must satisfy all of the following criteria at the Screening visit unless otherwise stated:
- Males or females, of any race, between 18 and 55 years of age (60 years for Part B), inclusive.
- Body mass index (BMI) of 18.0 to 32.0 kg/m^2 (inclusive) with a minimum body weight of 50 kg.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed further in the protocol.
Key exclusion criteria (29 listed)
- 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:
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GB1211Hard capsules for oral use | Drug | A1 - 5 mg GB1211 single dose and Placebo, A2 - 20 mg GB1211 single dose and Placebo, A3 - 50 mg GB1211 single dose (food effect cohort) and Placebo, A4 - 100 mg GB1211 single dose and Placebo, A5 - 200 mg GB1211 single dose and Placebo, A6 - 50mg GB1211 single dose and Placebo, A7 - 400 mg GB1211 single dose and Placebo, B1 - GB1211 multiple ascending doses, 50mg BID and Placebo, B2 - GB1211 multiple ascending doses, 100mg BID and Placebo |
| PlaceboAlso: GB1211Hard capsules for oral use | Drug | Part A - Placebo for GB1211, Part B - Placebo for GB1211 (BID) |
Primary outcome
Number of Participants With of Adverse Events (AEs)
Time frame: Up to 5-7 days post final dose (Part A: Single dose), Part B: 6-7 weeks
The number of participants in each arm that report Adverse Events (AEs)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36914828Aslanis 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.
- Individual participant dataSharing planned: No
Related trials for Safety and Tolerability
RecruitingPhase 1
Safety, Tolerability, and Pharmacokinetics of RCS-21 in Healthy Volunteers.
Healthy Volunteers, Safety
Recruiting
Safety and Tolerability Evaluation of IgG Binding Protein LT
Safety and Tolerability in Healthy Volunteers
Not yet recruitingPhase 1
A First-in-Human SAD and MAD Study in HV to Evaluate Oral YR011 Tablet
Safety, Tolerability
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
RecruitingPhase 1/2
Phase 1/2 Clinical Study of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors
Safety, Tolerability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Ashley Brooks, MBChB principal investigator
Covance
Dr Bertil Lindmark MD PHD, Chief Medical Officer study chair
Galecto Biotech AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GB1211 in people with Safety and Tolerability, run by Galecto Biotech AB at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With of Adverse Events (AEs) (time frame: Up to 5-7 days post final dose (Part A: Single dose), Part B: 6-7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03809052, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021; AzTrials last refreshed its copy on 27 Oct 2026.