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Trial registered on ANZCTR
Registration number
ACTRN12620001156976
Ethics application status
Approved
Date submitted
4/09/2020
Date registered
4/11/2020
Date last updated
17/03/2022
Date data sharing statement initially provided
4/11/2020
Type of registration
Retrospectively registered
Titles & IDs
Public title
A study to evaluate the safety, tolerability, pharmacokinetics (PK – how your body uses the study drug) and pharmacodynamics (PD – how the study drug carries out its actions on the body) profile of Inclacumab following a single intravenous infusion in healthy participants
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Scientific title
An Open-label, Single-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Inclacumab Following Intravenous Infusion in Healthy Participants
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Secondary ID [1]
302024
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GBT2104-111
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sickle Cell Disease
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Condition category
Condition code
Blood
316620
316620
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0
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Haematological diseases
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Human Genetics and Inherited Disorders
317255
317255
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Inclacumab is a recombinant human monoclonal antibody (huMAb) being developed for the treatment of sickle cell disease (SCD).
15 eligible participants will be enrolled in 2 dose cohorts and receive a single intravenous dose of 20 mg/kg or 40 mg/kg of inclacumab over a period of 1 hour. Doses will be administered by the study nurse.
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Intervention code [1]
318324
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Treatment: Drugs
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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To assess the safety and tolerability of inclacumab after a single dose at different dose levels in healthy participants. Safety and tolerability will be assessed through review of ongoing safety assessments including clinical laboratory testing, physical examination, ECG and vitals as well as recording of any side effects..
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Assessment method [1]
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Timepoint [1]
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Safety and tolerability will be assessed during the inpatient period following dosing (daily assessments for up to 4 days post-dose) and during the outpatient follow-up period, up to Day 203 (14 outpatient visits, 1-3 weeks apart)
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Secondary outcome [1]
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To characterize the plasma pharmacokinetics (PK) of inclacumab in healthy participants including but not limited to, Cmax, AUC, and T1/2
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Assessment method [1]
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Timepoint [1]
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Blood samples for PK will be collected at the following timepoint:
Day 1: pre-dose, end of infusion and 2, 6, & 12 hrs post end of infusion
Day 2, 3, 4, 8, 15, 22, 29, 43, 57, 71, 85, 99, 120, 141, 162, 183, 203
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Secondary outcome [2]
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To characterize the effect of inclacumab on pharmacodynamics (PD) in healthy participants including including P-selectin inhibition, platelet-leukocyte aggregation, and plasma soluble P-selectin
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Assessment method [2]
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Timepoint [2]
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Blood samples for PD will be collected at the following timepoint:
Day 1: pre-dose, end of infusion and 2, 6, & 12 hrs post end of infusion
Day 2, 3, 4, 8, 15, 29, 57, 71, 85, 99, 120, 141, 162, 183, 203
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Eligibility
Key inclusion criteria
1. Healthy male or female participants between 18 and 65 years of age, inclusive.
2. Participants in good health as determined by the Investigator’s review of medical history,
physical examination, vital sign measurements, 12-lead ECG, and clinical laboratory
tests.
3. Body weight equal to or greater than 50 kg (male) or equal to or greater than 45 kg (female), and equal to or less than 110 kg and a body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
4. Ability to comply with all the requirements of the study.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1.. Use of prescription medications or herbal remedies within 14 days of the Day -1 (with the
exceptions of hormonal contraceptives and other medications at the discretion of the
Investigator and/or Sponsor).
2. Use of over-the-counter medication within 7 days of the Day -1. Medications such as
paracetamol or non-steroidal anti-inflammatories and routinely taken dietary supplements
are allowed at the discretion of the Investigator and/or Sponsor.
3. Clinically significant abnormalities in laboratory results including:
a. Absolute neutrophil count (ANC) < 1.5 × 10^9/L;
b. Platelet count < 150 × 10^9/L;
c. Creatinine clearance (calculated by Cockcroft-Gault) < 60 mL/min;
d. Direct conjugated bilirubin >1.5 × upper limit of normal (ULN);
e. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 × ULN;
f. Hemoglobin < 12 g/dL.
4. History of alcohol abuse or use of drugs of abuse in the 12 months prior to the Day -1.
Excess alcohol is defined as more than 14 drinks/week for women and 21 drinks/week for
men. A drink is defined as 360 mL of beer, 150 mL of wine, or 45 mL of spirits.
5. Females who are pregnant or breastfeeding.
6. Prior exposure to inclacumab or crizanlizumab.
7. Received an investigational drug within 30 days or 5 half-lives, whichever is longer, of
the Day -1, or is currently participating in another trial of an investigational or marketed
drug (or medical device).
8. Vaccination with live vaccine (with the exception of seasonal flu vaccine) within 6 weeks of Day -1 or planning for vaccination while participating in the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Single study drug dose will be administered on Day 1 only
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Phase
Phase 1
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Type of endpoint/s
Safety
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Statistical methods / analysis
15 healthy volunteers between 18-65 years of age will be enrolled in this study.
Due to the exploratory nature of this study, no formal power or sample size calculations were used to determine cohort size. A sufficient number of healthy volunteers will be screened to ensure at least 6 participants are enrolled and dosed in each cohort.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
15/09/2020
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Date of last participant enrolment
Anticipated
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Actual
23/10/2020
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Date of last data collection
Anticipated
3/05/2021
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Actual
13/05/2021
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Sample size
Target
15
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Accrual to date
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Final
15
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
17252
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Linear Clinical Research - Nedlands
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Recruitment postcode(s) [1]
30964
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6009 - Nedlands
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Global Blood Therapeutics, Inc.
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Address [1]
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181 Oyster Point Blvd.
South San Francisco
CA 94080
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Country [1]
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Linear Clinical Research Ltd
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Address
Level 1, B Block
Hospital Ave
Nedlands WA 6009
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Country
Australia
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
306963
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Global Blood Therapeutics, Inc.
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Address [1]
306963
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181 Oyster Point Blvd.
South San Francisco
CA 94080
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Country [1]
306963
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United States of America
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306653
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Bellberry Limited
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Ethics committee address [1]
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123 Glen Osmond Rd Eastwood SA 5063
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Ethics committee country [1]
306653
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Australia
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Date submitted for ethics approval [1]
306653
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15/07/2020
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Approval date [1]
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25/08/2020
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Ethics approval number [1]
306653
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2020-07-658
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Summary
Brief summary
The purpose of this study is to assess the safety and tolerability of inclacumab, as well as the pharmacokinetics (PK – how your body uses the study drug) and pharmacodynamics (PD – how the study drug carries out its actions on the body). Inclacumab will be tested in 15 healthy participants aged 18 to 65 years. Participants will be administered a single doses of inclacumab as an intravenous infusion over 1 hour. Participants will then be followed up for 203 days for safety and PK/PD assessments
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Andrew Redfern
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Address
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Linear Clinical Research
Level 1, B Block, Hospital Ave
Nedlands, WA 6009
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Country
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Australia
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Phone
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+61 433 078 719
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Margot Hottmann
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Address
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Global Blood Therapeutics, Inc.
181 Oyster Point Blvd.
South San Francisco, CA 94080
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Country
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United States of America
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Phone
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+1 650 822 8728
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dan Cooper
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Address
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Global Blood Therapeutics, Inc.
181 Oyster Point Blvd.
South San Francisco, CA 94080
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Country
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United States of America
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Phone
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+1 650 888 9896
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Fax
104568
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
IPD will not be available.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
A phase 1 study in healthy participants to characterize the safety and pharmacology of inclacumab, a fully human anti-P-selectin antibody, in development for treatment of sickle cell disease.
2023
https://dx.doi.org/10.1007/s00228-023-03514-3
N.B. These documents automatically identified may not have been verified by the study sponsor.
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