NCT02220153

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2014

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 5, 2015

Status Verified

October 1, 2015

Enrollment Period

1.2 years

First QC Date

August 18, 2014

Last Update Submit

October 2, 2015

Conditions

Healthy

Keywords

Monoclonal antibodysubjectsFirst in human

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events during the study

    Day -1 up to Day 85

Secondary Outcomes (9)

  • Maximum plasma concentration (Cmax)

    Predose (Day 1) up to Day 85

  • Area under the curve from 0 to infinity (AUC)

    Predose (Day 1) up to Day 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

  • Time to reach Cmax (Tmax)

    Predose (Day 1) up to Day 85

  • Total Immunoglobulin G (IgG ) concentrations

    Predose (Day 1) up to Day 85

  • +4 more secondary outcomes

Study Arms (9)

UCB7665 Intravenous 1

EXPERIMENTAL

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

Biological: UCB7665 Intravenous 1

UCB7665 Intravenous 2

EXPERIMENTAL

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

Biological: UCB7665 Intravenous 2

UCB7665 Intravenous 3

EXPERIMENTAL

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

Biological: UCB7665 Intravenous 3

UCB7665 Intravenous 4

EXPERIMENTAL

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

Biological: UCB7665 Intravenous 4

UCB7665 Intravenous 5

EXPERIMENTAL

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

Biological: UCB7665 Intravenous 5

UCB7665 Subcutaneous 1

EXPERIMENTAL

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

Biological: UCB7665 Subcutaneous 1

UCB7665 Subcutaneous 2

EXPERIMENTAL

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

Biological: UCB7665 Subcutaneous 2

Intravenous Placebo

PLACEBO COMPARATOR

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

Biological: Intravenous Placebo

Subcutaneous Placebo

PLACEBO COMPARATOR

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

Biological: Subcutaneous Placebo

Interventions

UCB7665 Intravenous 1BIOLOGICAL

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

UCB7665 Intravenous 1
UCB7665 Intravenous 2BIOLOGICAL

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

UCB7665 Intravenous 2
UCB7665 Intravenous 3BIOLOGICAL

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

UCB7665 Intravenous 3
UCB7665 Intravenous 4BIOLOGICAL

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

UCB7665 Intravenous 4
UCB7665 Intravenous 5BIOLOGICAL

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

UCB7665 Intravenous 5
UCB7665 Subcutaneous 1BIOLOGICAL

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

UCB7665 Subcutaneous 1
UCB7665 Subcutaneous 2BIOLOGICAL

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

UCB7665 Subcutaneous 2
Intravenous PlaceboBIOLOGICAL

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

Intravenous Placebo
Subcutaneous PlaceboBIOLOGICAL

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

Subcutaneous Placebo

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

001

Harrow, Middlesex, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 29093180DERIVED

Study Officials

  • UCB Clinical Trial Call Center

    UCB Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2014

First Posted

August 19, 2014

Study Start

July 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 5, 2015

Record last verified: 2015-10

Locations

GB(1)