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
- Conditions
- Sickle Cell DiseaseBlood - Haematological diseasesHuman Genetics and Inherited Disorders - Other human genetics and inherited disorders
- Registration Number
- ACTRN12620001156976
- Lead Sponsor
- inear Clinical Research Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 15
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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..[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)]
- Secondary Outcome Measures
Name Time Method To characterize the plasma pharmacokinetics (PK) of inclacumab in healthy participants including but not limited to, Cmax, AUC, and T1/2<br>[Blood samples for PK will be collected at the following timepoint:<br>Day 1: pre-dose, end of infusion and 2, 6, & 12 hrs post end of infusion<br>Day 2, 3, 4, 8, 15, 22, 29, 43, 57, 71, 85, 99, 120, 141, 162, 183, 203];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[Blood samples for PD will be collected at the following timepoint:<br>Day 1: pre-dose, end of infusion and 2, 6, & 12 hrs post end of infusion<br>Day 2, 3, 4, 8, 15, 29, 57, 71, 85, 99, 120, 141, 162, 183, 203]