Healthy Volunteers
Conditions
Keywords
First in human, Healthy volunteers
Brief summary
This study is designed to evaluate the safety and tolerability of single ascending doses of UCB4019 administered by subcutaneous injection in healthy subjects.
Interventions
DRUGPR1
* Active substance: UCB4019 * Route of Administration: subcutaneously
OTHERPL1
* Active substance: Placebo * Concentration: 0.9 % saline * Route of Administration: subcutaneously
Sponsors
UCB Biopharma S.P.R.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Good physical and mental health * At least 18 and less than 65 years of age * Female subjects of childbearing potential must agree to use a highly effective method of birth control, during the study and for a period of 3 months after their last dose of study drug
Exclusion criteria
* Total Immunoglobulin G \<7 g/L or \>16 g/L at the Screening Visit * Absolute neutrophil count \<1.5x10\^9/L and/or lymphocyte count \<1.0x10\^9/L * Known viral hepatitis, has a positive test for Hepatitis B surface antigen or is Hepatitis C virus antibody positive * Positive test to Human Immunodeficiency Virus (HIV) 1/2 antibodies * Past medical history or family history of primary immunodeficiency * Evidence of latent/active Tuberculosis (TB) * Active infection or a serious infection within 6 weeks before the first dose of IMP * Renal impairment * Hepatic impairment * Vaccination within 6 weeks before the Screening Visit or intent to have a vaccination before Day 43 of the Safety Follow-up Period * Subject is splenectomized * received any IMP or experimental procedure within 90 days before the first dose of IMP * received UCB7665 in a clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment emergent adverse events during the study | Day 1 up to Day 57 | An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. |
Secondary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration (Cmax) | Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19 |
| Area under the curve from 0 to time t, the time of last quantifiable concentration [(AUC0-t)] | Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19 |
| Time to reach Cmax (Tmax) | Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19 |
| Change from Baseline in total Immunoglobulin G (IgG) concentration at day 7 | Predose (Day 1), Day 7 |
| Change from Baseline in total Immunoglobulin G (IgG) concentration at day 10 | Predose (Day 1), Day 10 |
| Change from Baseline in total Immunoglobulin G (IgG) concentration at day 13 | Predose (Day 1), Day 13 |
Countries
United Kingdom
Outcome results
None listed