- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04705350
A Study to Test Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous Doses of Zampilimab in Healthy Participants
July 15, 2022 updated by: UCB Biopharma SRL
A Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled Study Evaluating Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous Doses of Zampilimab in Healthy Participants
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of zampilimab in healthy study participants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom
- Up0105 001
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participant must be 18 to 55 years of age inclusive, at the time of signing the Informed Consent Form (ICF)
- Study participant must be considered reliable and capable of adhering to the protocol, according to the judgment of the Investigator, and is able to communicate satisfactorily with the Investigator and comply with all clinical study requirements
- Study participant has adequate peripheral venous access
- Study participant has clinical laboratory test results within the reference ranges of the testing laboratory. Study participants with test results that are outside the specified ranges and that are deemed as clinically nonsignificant will be allowed at the discretion of the Investigator
- Study participant is of normal weight as determined by a body mass index between 18 and 32 kg/m^2, inclusive, with a body weight of at least 50 kg (male) or 45 kg (female) and no greater than 100 kg
- Study participants may be male or female
- Male participants must agree to use contraception during treatment period and for 5 months; female participants of childbearing potential must be not pregnant or breastfeeding and agree to use contraception during the treatment period and for 5 months
Exclusion Criteria:
- Study participant has any medical (acute or chronic) or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the IMP; or interfering with the interpretation of data
- Study participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) as stated in this protocol or participant has a history of moderate to severe allergic reaction to medication(s), including biologics
- Study participant has any clinically relevant abnormal findings in physical examination, laboratory tests, vital signs, or electrocardiogram (ECG), which, in the opinion of the Investigator, may place the participant at risk because of participation in the study
- Study participant has had major surgery (including joint surgery) within 6 months prior to the Screening Period, or has planned surgery within 6 months after IMP
- Study participant has current diagnosis or history of wound healing complications
- Study participant has a history of alcohol and/or drug abuse up to 6 months before the Screening Period
- Study participant has active neoplastic disease or history of neoplastic disease within 5 years of the Screening Period
- Study participant has an active infection during the Screening Period
- Study participant has clinical signs and symptoms consistent with coronavirus disease (COVID-19) or had a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test result within the last 4 weeks prior to the Screening Period or on admission
- Study participant has had a severe course of COVID-19 that required hospitalization
- Study participant has received any prescription or nonprescription medicines, including over the counter (OTC) remedies or herbal and dietary supplements, within 14 days or 5 half-lives of the respective drug, whichever is longer, other than the occasional use of analgesics, such as paracetamol (acetaminophen) or ibuprofen, oral contraceptives, or inhaled corticosteroids for seasonal rhinitis
- Study participant has received treatment with biologic agents (such as monoclonal antibodies (mAbs) including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
- Study participant has received a vaccination within 8 weeks prior to Day 1; or intends to have a vaccination during the course of the study
- Study participant has participated in another study of a IMP (and/or an investigational device) within the previous 3 months or 5 half-lives prior to the Screening Period, whichever is longer, or is currently participating in another study of a IMP (and/or an investigational device)
- Study participant has positive serology test for hepatitis B surface antigen, hepatitis B core antibodies (both immunoglobulin G (IgG) and IgM), hepatitis C virus antibodies, or antibodies to human immunodeficiency virus type 1 and/or type 2 during the Screening Period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Zampilimab Cohorts
Participants will be randomized to receive predefined single doses of zampilimab.
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Participants will receive a single intravenous dose of zampilimab at a pre-specified time point.
Other Names:
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Placebo Comparator: Placebo
Participants randomized to this arm will receive matching Placebo to maintain the blinding.
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Participants will receive matching placebo at a pre-specified time point to maintain the blinding.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidents of treatment-emergent adverse events (TEAEs) through the Safety Follow-up (SFU) Visit
Time Frame: From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days)
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A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the administration of investigational medicinal product (IMP) or any unresolved event already present before administration of IMP that worsens in intensity following exposure to the treatment.
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From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days)
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Maximum intensity of treatment-emergent adverse events (TEAEs) through the Safety Follow-up (SFU) Visit
Time Frame: From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days)
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Maximum intensity across all incidents of each TEAE for each study participant
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From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum zampilimab serum concentration (Cmax)
Time Frame: From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days)
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Cmax: Maximum observed zampilimab serum concentration
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From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days)
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Time to maximum zampilimab serum concentration (tmax)
Time Frame: From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days)
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tmax: Time to maximum observed zampilimab serum concentration
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From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days)
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Area under the zampilimab serum concentration-time curve from time zero to last quantifiable concentration (AUC0-t)
Time Frame: From Day 1 (Start of Treatment Period) at predefined time points to the last quantifiable concentration (up to 120 days)
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AUC0-t: Area under the zampilimab serum concentration-time curve from time zero (Day 1) to the last quantifiable concentration
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From Day 1 (Start of Treatment Period) at predefined time points to the last quantifiable concentration (up to 120 days)
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Area under the zampilimab serum concentration-time curve from time zero to infinity (AUC)
Time Frame: Day 1 (Start of Treatment Period) at predefined time points (up to 120 days)
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AUC: Area under the zampilimab serum concentration-time curve from time 0 (Day 1) to infinity
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Day 1 (Start of Treatment Period) at predefined time points (up to 120 days)
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Clearance (CL) of zampilimab in serum
Time Frame: From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days)
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CL: volume of serum that is cleared from zampilimab per unit of time
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From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days)
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Apparent volume of distribution during terminal phase (Vz) of zampilimab
Time Frame: From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days)
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Vz: apparent volume of distribution during terminal phase
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From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days)
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Apparent terminal half-life (t1/2) of zampilimab
Time Frame: From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days)
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t1/2: terminal zampilimab serum half-life
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From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: UCB Cares, 001 844 599 2273 (UCB)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 11, 2021
Primary Completion (Actual)
July 28, 2021
Study Completion (Actual)
July 28, 2021
Study Registration Dates
First Submitted
January 8, 2021
First Submitted That Met QC Criteria
January 8, 2021
First Posted (Actual)
January 12, 2021
Study Record Updates
Last Update Posted (Actual)
July 19, 2022
Last Update Submitted That Met QC Criteria
July 15, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- UP0105
- 2020-004411-26 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified.
For this reason, data from this trial cannot be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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