A First-In-Human Study With a Single Dose UCB7665 in Healthy Volunteers

Healthy 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 Intravenous and Subcutaneous Doses of UCB7665 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02220153
• Other study ID #: UP0018
• Secondary ID: 2013-005469-38
• Status: Completed
• Phase: Phase 1
• First received: August 18, 2014
• Last updated: October 2, 2015
• Start date: July 2014
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the safety and tolerability of single ascending doses of UCB7665 administered by intravenous or subcutaneous infusion in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Healthy male and female volunteers of non-childbearing potential who gave their consent to the written informed consent form

• Healthy volunteers in the age between 18 and 64 years old with normal weight as determined by a body mass index (BMI) between 18 and 30 kg/m^2, with a body weight of at least 50 kg for male subjects or 45 kg for female subjects

• Subjects has blood pressure (BP) and pulse within normal range in a supine position after 5 minutes rest

• Subject has clinical laboratory test results within the reference ranges of the testing laboratory or test results that are outside the specified ranges and that are deemed as clinically non-significant

• Subject's electrocardiogram (ECG) is considered "normal" or "abnormal" but clinically non-significant

Exclusion Criteria:

• Subject has had significant blood loss, or has donated blood in excess of 400 mL of blood or blood products within 90 days before Day -2, or plans to donate blood during the clinical study

• Subject has a total Immuneglobulin G <7 g/L or >16 g/L at the Screening Visit

• Subject has absolute neutrophil count <1.5x10^9/L and/or lymphocyte count <1.0x10^9/L

• Subject has known viral hepatitis, has a positive test for Hepatitis B surface antigen or is Hepatitis C virus antibody positive

• Subject tests positive to Human Immunodeficiency Virus (HIV) 1/2 antibodies

• Subject has a past medical history or family history of primary immunodeficiency

• Subject is splenectomized

• Subject has a positive TIGRA (T cell interferon ? release assay) at the Screening Visit. If TIGRA is not available, purified protein derivative (PPD) skin test can be substituted and/or chest x-ray performed within 6 months before the Screening Visit showing no evidence of latent/active Tuberculosis (TB)

• Subject has past (in the last 12 months ) or present substance abuse/dependence or concurrent medical conditions that in the opinion of the investigator could confound clinical study interpretation or affect the subject's ability to fully participate in the clinical study

• Subject has a known hypersensitivity to any components of the Investigational Medicinal Product (IMP)

• Subject has an active infection or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks before the first dose of IMP

• Subject has 12-lead electrocardiogram (ECG) with changes considered to be clinically significant upon medical review

• Subject has renal impairment

• Subject has hepatic impairment

• Subject has corrected serum calcium of >11.5 mg/dL (>2.9 mmol/L) or <8.0 mg/dL (<2.0 mmol/L) at the Screening Visit

• Subject has active neoplastic disease or history of neoplastic disease within 5 years of entry in the clinical study

• Subject has any other acute or chronic illness which, in the opinion of the investigator or study physician, could pose a threat or harm to the subjects

• Subject has received a vaccination within 6 weeks before the Screening Visit or intends to have a vaccination before Day 43 of the Safety Follow-up Period

• Subject has received any IMP or experimental procedure within 90 days before the first dose of IMP

• Subject requires a treatment other than Paracetamol during the clinical study

• Subject is a vulnerable subject (e.g. subject kept in detention) (Declaration of Helsinki, 1996)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• UCB7665 Intravenous 1
Active substance: UCB7665 Pharmaceutical form: solution Concentration: 140 mg/mL Route of Administration: intravenous infusion
• UCB7665 Intravenous 2
Active substance: UCB7665 Pharmaceutical form: solution Concentration: 140 mg/mL Route of Administration: intravenous infusion
• UCB7665 Intravenous 3
Active substance: UCB7665 Pharmaceutical form: solution Concentration: 140 mg/mL Route of Administration: intravenous infusion
• UCB7665 Intravenous 4
Active substance: UCB7665 Pharmaceutical form: solution Concentration: 140 mg/mL Route of Administration: intravenous infusion
• UCB7665 Intravenous 5
Active substance: UCB7665 Pharmaceutical form: solution Concentration: 140 mg/mL Route of Administration: intravenous infusion
• UCB7665 Subcutaneous 1
Active substance: UCB7665 Pharmaceutical form: solution Concentration: 140 mg/mL Route of Administration: subcutaneous infusion
• UCB7665 Subcutaneous 2
Active substance: UCB7665 Pharmaceutical form: solution Concentration: 140 mg/mL Route of Administration: subcutaneous infusion
• Intravenous Placebo
Active substance: Placebo Pharmaceutical form: solution Concentration: 0.9 % saline Route of Administration: intravenous infusion
• Subcutaneous Placebo
Active substance: Placebo Pharmaceutical form: solution Concentration: 0.9 % saline Route of Administration: subcutaneous infusion

Locations

Country	Name	City	State
United Kingdom	001	Harrow	Middlesex

Sponsors (2)

Lead Sponsor	Collaborator
UCB Celltech	Parexel

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events during the study		Day -1 up to Day 85	No
Secondary	Maximum plasma concentration (Cmax)	The value of the maximum plasma concentration will be directly obtained from the observed plasma concentration versus time curves. Pharmacokinetic samples will be taken predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.	Predose (Day 1) up to Day 85	No
Secondary	Area under the curve from 0 to infinity (AUC)	AUC will be calculated using plasma concentrations taken at predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.	Predose (Day 1) up to Day 85	No
Secondary	Area under the curve from time 0 to time t, the time of last quantifiable concentration [AUC(0-t)]	AUC(0-t) will be calculated using plasma concentrations taken at predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.	Predose (Day 1) up to Day 85	No
Secondary	Time to reach Cmax (Tmax)	Tmax will be directly obtained from the observed plasma concentration versus time curves, using plasma concentrations taken at predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.	Predose (Day 1) up to Day 85	No
Secondary	Total Immunoglobulin G (IgG ) concentrations	Total Immunoglobulin G will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.	Predose (Day 1) up to Day 85	Yes
Secondary	Immunoglobulin G1 subclass concentrations	Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.	Predose (Day 1) up to Day 85	Yes
Secondary	Immunoglobulin G2 subclass concentrations	Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.	Predose (Day 1) up to Day 85	Yes
Secondary	Immunoglobulin G3 subclass concentrations	Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.	Predose (Day 1) up to Day 85	Yes
Secondary	Immunoglobulin G4 subclass concentrations	Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.	Predose (Day 1) up to Day 85	Yes