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

Sponsor

UCB Celltech (Industry)

Overall Status

Completed

CT.gov ID

NCT02220153

Collaborator

Parexel (Industry)

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Biological: UCB7665 Intravenous 1 Biological: UCB7665 Intravenous 2 Biological: UCB7665 Intravenous 3 Biological: UCB7665 Intravenous 4 Biological: UCB7665 Intravenous 5 Biological: UCB7665 Subcutaneous 1 Biological: UCB7665 Subcutaneous 2 Biological: Intravenous Placebo Biological: Subcutaneous Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: UCB7665 Intravenous 1 Single dose calculated based on body weight for 60 minutes intravenous infusion.	Biological: UCB7665 Intravenous 1 Active substance: UCB7665 Pharmaceutical form: solution Concentration: 140 mg/mL Route of Administration: intravenous infusion
Experimental: UCB7665 Intravenous 2 Single dose calculated based on body weight for 60 minutes intravenous infusion.	Biological: UCB7665 Intravenous 2 Active substance: UCB7665 Pharmaceutical form: solution Concentration: 140 mg/mL Route of Administration: intravenous infusion
Experimental: UCB7665 Intravenous 3 Single dose calculated based on body weight for 60 minutes intravenous infusion.	Biological: UCB7665 Intravenous 3 Active substance: UCB7665 Pharmaceutical form: solution Concentration: 140 mg/mL Route of Administration: intravenous infusion
Experimental: UCB7665 Intravenous 4 Single dose calculated based on body weight for 60 minutes intravenous infusion.	Biological: UCB7665 Intravenous 4 Active substance: UCB7665 Pharmaceutical form: solution Concentration: 140 mg/mL Route of Administration: intravenous infusion
Experimental: UCB7665 Intravenous 5 Single dose calculated based on body weight for 60 minutes intravenous infusion.	Biological: UCB7665 Intravenous 5 Active substance: UCB7665 Pharmaceutical form: solution Concentration: 140 mg/mL Route of Administration: intravenous infusion
Experimental: UCB7665 Subcutaneous 1 Single dose calculated based on body weight for 60 minutes subcutaneous infusion.	Biological: UCB7665 Subcutaneous 1 Active substance: UCB7665 Pharmaceutical form: solution Concentration: 140 mg/mL Route of Administration: subcutaneous infusion
Experimental: UCB7665 Subcutaneous 2 Single dose calculated based on body weight for 60 minutes subcutaneous infusion.	Biological: UCB7665 Subcutaneous 2 Active substance: UCB7665 Pharmaceutical form: solution Concentration: 140 mg/mL Route of Administration: subcutaneous infusion
Placebo Comparator: Intravenous Placebo Single dose placebo comparator for each active arm of intravenous infusion.	Biological: Intravenous Placebo Active substance: Placebo Pharmaceutical form: solution Concentration: 0.9 % saline Route of Administration: intravenous infusion
Placebo Comparator: Subcutaneous Placebo Single dose placebo comparator for each active arm of subcutaneous infusion.	Biological: Subcutaneous Placebo Active substance: Placebo Pharmaceutical form: solution Concentration: 0.9 % saline Route of Administration: subcutaneous infusion

Outcome Measures

Primary Outcome Measures

Incidence of adverse events during the study [Day -1 up to Day 85]

Secondary Outcome Measures

Maximum plasma concentration (Cmax) [Predose (Day 1) up to Day 85]
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.
Area under the curve from 0 to infinity (AUC) [Predose (Day 1) up to Day 85]
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.
Area under the curve from time 0 to time t, the time of last quantifiable concentration [AUC(0-t)] [Predose (Day 1) up to Day 85]
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.
Time to reach Cmax (Tmax) [Predose (Day 1) up to Day 85]
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.
Total Immunoglobulin G (IgG ) concentrations [Predose (Day 1) up to Day 85]
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.
Immunoglobulin G1 subclass concentrations [Predose (Day 1) up to Day 85]
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.
Immunoglobulin G2 subclass concentrations [Predose (Day 1) up to Day 85]
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.
Immunoglobulin G3 subclass concentrations [Predose (Day 1) up to Day 85]
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.
Immunoglobulin G4 subclass concentrations [Predose (Day 1) up to Day 85]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 γ 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	001	Harrow	Middlesex	United Kingdom

Sponsors and Collaborators

UCB Celltech
Parexel

Investigators

Study Director: UCB Clinical Trial Call Center, UCB Pharma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

UCB Celltech

ClinicalTrials.gov Identifier:

NCT02220153

Other Study ID Numbers:

UP0018
2013-005469-38

First Posted:

Aug 19, 2014

Last Update Posted:

Oct 5, 2015

Last Verified:

Oct 1, 2015

Keywords provided by UCB Celltech

Monoclonal antibody

subjects

First in human

Additional relevant MeSH terms:

Rozanolixizumab

Study Results

No Results Posted as of Oct 5, 2015