A First-In-Human Study With a Single Dose UCB4019 in Healthy Volunteers

Study Overview
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Brief Summary
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This study is designed to evaluate the safety and tolerability of single ascending doses of UCB4019 administered by subcutaneous injection in healthy subjects.

Official Title
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A Subject-Blind, Investigator-Blind, Randomized, Placebo-Controlled, First-In-Human Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Subcutaneous Doses of UCB4019 in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: PR1
* Other: PL1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Single dose placebo comparator for each active arm | Other: PL1<br>* Active substance: Placebo Concentration: 0.9 % saline Route of Administration: subcutaneously<br>|
| Experimental: UCB4019 Dose 1<br>Dose 1 calculated based on body weight | Drug: PR1<br>* Active substance: UCB4019 Route of Administration: subcutaneously<br>|
| Experimental: UCB4019 Dose 2<br>Dose 2 calculated based on body weight | Drug: PR1<br>* Active substance: UCB4019 Route of Administration: subcutaneously<br>|
| Experimental: UCB4019 Dose 3<br>Dose 3 calculated based on body weight | Drug: PR1<br>* Active substance: UCB4019 Route of Administration: subcutaneously<br>|
| Experimental: UCB4019 Dose 4<br>Dose 4 calculated based on body weight | Drug: PR1<br>* Active substance: UCB4019 Route of Administration: subcutaneously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment emergent adverse events during the study | 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. | Day 1 up to Day 57 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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First in human, Healthy volunteers