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

UCB

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Biological: UCB7665 Intravenous 4

Biological: UCB7665 Subcutaneous 1

Biological: UCB7665 Intravenous 1

Biological: UCB7665 Intravenous 2

Biological: Intravenous Placebo

Biological: UCB7665 Subcutaneous 2

Biological: UCB7665 Intravenous 3

Biological: UCB7665 Intravenous 5

Biological: Subcutaneous Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02220153

UP0018

2013-005469-38 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

41 participants in 9 patient groups, including a placebo group

UCB7665 Intravenous 1

Experimental group

Description: