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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02873767
• Other study ID #: UP0028
• Secondary ID: 2016-000772-26
• Status: Completed
• Phase: Phase 1
• First received: August 16, 2016
• Last updated: February 8, 2017
• Start date: August 2016
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• PR1
Active substance: UCB4019 Route of Administration: subcutaneously

Other:
• PL1
Active substance: Placebo Concentration: 0.9 % saline Route of Administration: subcutaneously

Locations

Country	Name	City	State
United Kingdom	Up0028 001	London

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma S.P.R.L.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change from Baseline in total Immunoglobulin G (IgG) concentration at day 7		Predose (Day 1), Day 7
Secondary	Change from Baseline in total Immunoglobulin G (IgG) concentration at day 10		Predose (Day 1), Day 10
Secondary	Change from Baseline in total Immunoglobulin G (IgG) concentration at day 13		Predose (Day 1), Day 13