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

UCB

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Other: PL1; Drug: PR1

Study type: Interventional

Funder types: Industry

Identifiers

NCT02873767

UP0028

2016-000772-26 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Single dose placebo comparator for each active arm

Treatment:

Other: PL1

UCB4019 Dose 1

Experimental group

Description:

Dose 1 calculated based on body weight

Treatment:

Drug: PR1

UCB4019 Dose 2

Experimental group

Description:

Dose 2 calculated based on body weight

Treatment:

Drug: PR1

UCB4019 Dose 3

Experimental group

Description:

Dose 3 calculated based on body weight

Treatment:

Drug: PR1

UCB4019 Dose 4

Experimental group

Description:

Dose 4 calculated based on body weight

Treatment:

Drug: PR1