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

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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