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

• Sponsor: UCB Biopharma S.P.R.L. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02873767
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 5
• Duration (Months): 6
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: PR1; Other: PL1	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Basic Science
• 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
• Study Start Date: Aug 1, 2016
• Actual Primary Completion Date: Feb 1, 2017
• Actual Study Completion Date: Feb 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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]

2. 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]

3. 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]

4. Change from Baseline in total Immunoglobulin G (IgG) concentration at day 7 [Predose (Day 1), Day 7]

5. Change from Baseline in total Immunoglobulin G (IgG) concentration at day 10 [Predose (Day 1), Day 10]

6. Change from Baseline in total Immunoglobulin G (IgG) concentration at day 13 [Predose (Day 1), Day 13]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Up0028 001	London		United Kingdom

Sponsors and Collaborators

• UCB Biopharma S.P.R.L.

Investigators

• Study Director: UCB Cares, UCB ([phone])

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: UCB Biopharma S.P.R.L.
• ClinicalTrials.gov Identifier: NCT02873767
• Other Study ID Numbers: UP0028; 2016-000772-26
• First Posted: Aug 19, 2016
• Last Update Posted: Feb 9, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by UCB Biopharma S.P.R.L.: First in human; Healthy volunteers

Study Results

No Results Posted as of Feb 9, 2017