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

NCT ID: NCT02220153

Last Updated: 2015-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-09-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

UCB7665 Intravenous 1

Single dose calculated based on body weight for 60 minutes intravenous infusion.

Group Type: EXPERIMENTAL

UCB7665 Intravenous 1

Intervention Type: BIOLOGICAL

• Active substance: UCB7665
• Pharmaceutical form: solution
• Concentration: 140 mg/mL
• Route of Administration: intravenous infusion

UCB7665 Intravenous 2

Single dose calculated based on body weight for 60 minutes intravenous infusion.

Group Type: EXPERIMENTAL

UCB7665 Intravenous 2

Intervention Type: BIOLOGICAL

• Active substance: UCB7665
• Pharmaceutical form: solution
• Concentration: 140 mg/mL
• Route of Administration: intravenous infusion

UCB7665 Intravenous 3

Single dose calculated based on body weight for 60 minutes intravenous infusion.

Group Type: EXPERIMENTAL

UCB7665 Intravenous 3

Intervention Type: BIOLOGICAL

• Active substance: UCB7665
• Pharmaceutical form: solution
• Concentration: 140 mg/mL
• Route of Administration: intravenous infusion

UCB7665 Intravenous 4

Single dose calculated based on body weight for 60 minutes intravenous infusion.

Group Type: EXPERIMENTAL

UCB7665 Intravenous 4

Intervention Type: BIOLOGICAL

• Active substance: UCB7665
• Pharmaceutical form: solution
• Concentration: 140 mg/mL
• Route of Administration: intravenous infusion

UCB7665 Intravenous 5

Single dose calculated based on body weight for 60 minutes intravenous infusion.

Group Type: EXPERIMENTAL

UCB7665 Intravenous 5

Intervention Type: BIOLOGICAL

• Active substance: UCB7665
• Pharmaceutical form: solution
• Concentration: 140 mg/mL
• Route of Administration: intravenous infusion

UCB7665 Subcutaneous 1

Single dose calculated based on body weight for 60 minutes subcutaneous infusion.

Group Type: EXPERIMENTAL

UCB7665 Subcutaneous 1

Intervention Type: BIOLOGICAL

• Active substance: UCB7665
• Pharmaceutical form: solution
• Concentration: 140 mg/mL
• Route of Administration: subcutaneous infusion

UCB7665 Subcutaneous 2

Single dose calculated based on body weight for 60 minutes subcutaneous infusion.

Group Type: EXPERIMENTAL

UCB7665 Subcutaneous 2

Intervention Type: BIOLOGICAL

• Active substance: UCB7665
• Pharmaceutical form: solution
• Concentration: 140 mg/mL
• Route of Administration: subcutaneous infusion

Intravenous Placebo

Single dose placebo comparator for each active arm of intravenous infusion.

Group Type: PLACEBO_COMPARATOR

Intravenous Placebo

Intervention Type: BIOLOGICAL

• Active substance: Placebo
• Pharmaceutical form: solution
• Concentration: 0.9 % saline
• Route of Administration: intravenous infusion

Subcutaneous Placebo

Single dose placebo comparator for each active arm of subcutaneous infusion.

Group Type: PLACEBO_COMPARATOR

Subcutaneous Placebo

Intervention Type: BIOLOGICAL

• Active substance: Placebo
• Pharmaceutical form: solution
• Concentration: 0.9 % saline
• Route of Administration: subcutaneous infusion

Interventions

UCB7665 Intravenous 1

• Active substance: UCB7665
• Pharmaceutical form: solution
• Concentration: 140 mg/mL
• Route of Administration: intravenous infusion

Intervention Type: BIOLOGICAL

UCB7665 Intravenous 2

• Active substance: UCB7665
• Pharmaceutical form: solution
• Concentration: 140 mg/mL
• Route of Administration: intravenous infusion

Intervention Type: BIOLOGICAL

UCB7665 Intravenous 3

• Active substance: UCB7665
• Pharmaceutical form: solution
• Concentration: 140 mg/mL
• Route of Administration: intravenous infusion

Intervention Type: BIOLOGICAL

UCB7665 Intravenous 4

• Active substance: UCB7665
• Pharmaceutical form: solution
• Concentration: 140 mg/mL
• Route of Administration: intravenous infusion

Intervention Type: BIOLOGICAL

UCB7665 Intravenous 5

• Active substance: UCB7665
• Pharmaceutical form: solution
• Concentration: 140 mg/mL
• Route of Administration: intravenous infusion

Intervention Type: BIOLOGICAL

UCB7665 Subcutaneous 1

• Active substance: UCB7665
• Pharmaceutical form: solution
• Concentration: 140 mg/mL
• Route of Administration: subcutaneous infusion

Intervention Type: BIOLOGICAL

UCB7665 Subcutaneous 2

• Active substance: UCB7665
• Pharmaceutical form: solution
• Concentration: 140 mg/mL
• Route of Administration: subcutaneous infusion

Intervention Type: BIOLOGICAL

Intravenous Placebo

• Active substance: Placebo
• Pharmaceutical form: solution
• Concentration: 0.9 % saline
• Route of Administration: intravenous infusion

Intervention Type: BIOLOGICAL

Subcutaneous Placebo

• Active substance: Placebo
• Pharmaceutical form: solution
• Concentration: 0.9 % saline
• Route of Administration: subcutaneous infusion

Intervention Type: BIOLOGICAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

UCB Celltech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

UCB Pharma

Locations

001

Harrow, Middlesex, United Kingdom

Countries

United Kingdom

References

Kiessling P, Lledo-Garcia R, Watanabe S, Langdon G, Tran D, Bari M, Christodoulou L, Jones E, Price G, Smith B, Brennan F, White I, Jolles S. The FcRn inhibitor rozanolixizumab reduces human serum IgG concentration: A randomized phase 1 study. Sci Transl Med. 2017 Nov 1;9(414):eaan1208. doi: 10.1126/scitranslmed.aan1208.

Reference Type: DERIVED

PMID: 29093180 (View on PubMed)

Other Identifiers

2013-005469-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

UP0018

Identifier Type: -

Identifier Source: org_study_id