None listed
Conditions
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
Interventions
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.
Sponsors
Linear Clinical Research Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed