NCT02873767

Brief Summary

This study is designed to evaluate the safety and tolerability of single ascending doses of UCB4019 administered by subcutaneous injection in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Aug 2016

Typical duration for phase_1 healthy-volunteers

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

August 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

August 16, 2016

Last Update Submit

February 8, 2017

Conditions

Healthy Volunteers

Keywords

First in humanHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Incidence of treatment emergent adverse events during the study

    An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.

    Day 1 up to Day 57

Secondary Outcomes (6)

  • Maximum plasma concentration (Cmax)

    Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19

  • Area under the curve from 0 to time t, the time of last quantifiable concentration [(AUC0-t)]

    Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19

  • Time to reach Cmax (Tmax)

    Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19

  • Change from Baseline in total Immunoglobulin G (IgG) concentration at day 7

    Predose (Day 1), Day 7

  • Change from Baseline in total Immunoglobulin G (IgG) concentration at day 10

    Predose (Day 1), Day 10

  • +1 more secondary outcomes

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Single dose placebo comparator for each active arm

Other: PL1

UCB4019 Dose 1

EXPERIMENTAL

Dose 1 calculated based on body weight

Drug: PR1

UCB4019 Dose 2

EXPERIMENTAL

Dose 2 calculated based on body weight

Drug: PR1

UCB4019 Dose 3

EXPERIMENTAL

Dose 3 calculated based on body weight

Drug: PR1

UCB4019 Dose 4

EXPERIMENTAL

Dose 4 calculated based on body weight

Drug: PR1

Interventions

PR1DRUG

* Active substance: UCB4019 * Route of Administration: subcutaneously

UCB4019 Dose 1UCB4019 Dose 2UCB4019 Dose 3UCB4019 Dose 4
PL1OTHER

* Active substance: Placebo * Concentration: 0.9 % saline * Route of Administration: subcutaneously

Placebo

Eligibility Criteria

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

You may qualify if:

  • Good physical and mental health
  • At least 18 and less than 65 years of age
  • Female subjects of childbearing potential must agree to use a highly effective method of birth control, during the study and for a period of 3 months after their last dose of study drug

You may not qualify if:

  • Total Immunoglobulin G \<7 g/L or \>16 g/L at the Screening Visit
  • Absolute neutrophil count \<1.5x10\^9/L and/or lymphocyte count \<1.0x10\^9/L
  • Known viral hepatitis, has a positive test for Hepatitis B surface antigen or is Hepatitis C virus antibody positive
  • Positive test to Human Immunodeficiency Virus (HIV) 1/2 antibodies
  • Past medical history or family history of primary immunodeficiency
  • Evidence of latent/active Tuberculosis (TB)
  • Active infection or a serious infection within 6 weeks before the first dose of IMP
  • Renal impairment
  • Hepatic impairment
  • Vaccination within 6 weeks before the Screening Visit or intent to have a vaccination before Day 43 of the Safety Follow-up Period
  • Subject is splenectomized
  • received any IMP or experimental procedure within 90 days before the first dose of IMP
  • received UCB7665 in a clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Up0028 001

London, United Kingdom

Location

Study Officials

  • UCB Cares

    UCB (+1 887 822 9493)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 19, 2016

Study Start

August 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

February 9, 2017

Record last verified: 2017-02

Locations

GB(1)