None listed
Conditions
Brief summary
What is this study about? Biocon Research Limited (India) is developing itolizumab, a humanised monoclonal antibody which is aimed at modifying disease course of various auto-immune diseases. The aim of this study is to study the safety and pharmacokinetics of single ascending doses of Itolizumab (Bmab 600) given subcutaneously and also compare the PK of two formulations of itolizumab given intravenously and subcutaneously and determine the absolute bioavailability of Bmab 600 given subcutaneously.. Who is this study for? This study is for healthy volunteers aged between 18 and 50 years and Body Mass Index between 18-30 kg/m2. What is involved? The study has 2 Stages. Stage 1 will investigate the safety and tolerability of Bmab-600, when administered to healthy volunteers as a subcutaneous injection. That is to find out how it makes people feel and whether there are any side effects or changes to laboratory results. The pharmacokinetics (PK) of single, ascending doses of Bmab-600 will also be investigated. Pharmacokinetics is a science that looks at how the body absorbs, distributes, breaks down and then removes the study product from the body. This will be done by analysing the levels of Bmab-600 that are present in blood at various times following each dose. It will also evaluate whether there are any effects on immune system. Stage two will compare the two formulations of itolizumab – It will investigate if these formulations are processed by the body in the same way, and if they have the same effect. There will be a screening visit which could be up to 28 days before the dosing day and a 3 day confinement period at the study centre. After that, there will be approximately 9 out patient clinic visits. Individual participation in the study will be up to 16 weeks.
Interventions
Itolizumab (Bmab 600)
In Stage 1 -escalating single doses administered subcutaneously at 0.8, 1.6, 2.4 and 3.2 mg/kg dose levels.
In Stage 2 – single dose of 0.8mg/kg administered subcutaneously or intravenous infusion at 0.8 mg/kg dose level over 2 hours
Itolizumab (NS0)
Stage 2- single dose administered as intravenous infusion at 0.8 mg/kg dose level over 2 hours.
All doses will be administered in the clinic by study staff.
Sponsors
Biocon Research Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female between 18 and 50 years of age (inclusive). 2. Healthy with no clinically significant medical problems. 3. BMI between 18 to 30 kg/m2 with weight between 50 to 100 kg (both inclusive). 4. No history of alcohol or drug abuse (Paracetamol, Barbiturates, Benzodiazepines, Cocaine, Methadone, Amphetamines, Methamphetamines, Opiates, Phencyclidine, Tetrahydrocannabinol (cannabis), Tricyclic Antidepressants). Subjects should be enrolled only after passing the urine drug screen (positive test for paracetamol will be allowed). 5. Non smokers or light smokers (Less than 5 cigarettes per day) by history and planned during study. 6. No history of significant allergic diathesis such as urticaria, angioedema or anaphylaxis. 7. No prior exposure to Itolizumab or other biologicals including monoclonal antibodies, fusion proteins etc. 8. Willing and able to sign written, informed consent.
Exclusion criteria
1. Any significant past or current cardiac, pulmonary, hepatic, renal or other medical condition which in the opinion of the investigator would make participation of the subject in this study medically unsafe or compromise the accuracy of assessment of safety, pharmacokinetic and pharmacodynamic data of the study. 2. Subjects who have abnormal safety labs outside the local lab ranges will be excluded as per PI's discretion based on his/her assessment of clinical significance. 3. Subjects with past medical history of malignancy except basal cell or squamous cell carcinoma of the skin who have had curative surgical treatment and at least 6 months has elapsed since the procedure. 4. A value outside the specified range of 90 mm Hg – 140 mm Hg for systolic blood pressure and 50 mm Hg – 90 mm Hg for diastolic blood pressure (both inclusive) at screening. 5. Subjects who show a positive Quantiferon TB test for tuberculosis will be excluded. Subjects with history of tuberculosis will be excluded irrespective of prior successful treatment. 6. History of clinically significant acute bacterial, viral, or fungal systemic infections in the last 4 weeks prior to screening. 7. Clinical or laboratory evidence of an active infection at the time of screening. 8. Serological evidence of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (Anti-HCV) at screening. 9. Vaccination within 3 months of screening for the study or requiring vaccination during the study or within 3 months after completion of the study. 10. Females who are pregnant or nursing. 11. Females of childbearing potential (i.e., any woman who is not surgically sterile e.g., hysterectomy, bilateral oophorectomy or more than 2 years post menopause) and all men who, if participating in heterosexual sexual activity that could lead to pregnancy are unable or unwilling to practice medically effective contraception during the study. They should agree to use two reliable methods of contraception (e.g., double-barrier condom plus diaphragm, condom or diaphragm plus stable dose of hormonal contraception) throughout the study period and until 3 months after receiving study drug. Women of childbearing potential will require compulsory pregnancy testing. A negative pregnancy test (serum and urine) will be documented during screening and at Day -1 respectively. 12. Participation in any other drug study within 8 weeks or 5 half lives of the study drug whichever is longer. 13. Unable or unwilling to comply with the protocol requirements for study visits and procedures. 14. Subjects who do not have good venous access for infusion of study drug or for blood sampling. 15. History of hypersensitivity to diphenhydramine or paracetamol.
Outcome results
None listed