A Study to Test Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous Doses of Zampilimab in Healthy Participants

NCT ID: NCT04705350

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-11
• Study Completion Date: 2021-07-28

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of zampilimab in healthy study participants.

Conditions

Healthy Study Participants

Study Design

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

Study Groups

Zampilimab Cohorts

Participants will be randomized to receive predefined single doses of zampilimab.

Group Type: EXPERIMENTAL

Zampilimab

Intervention Type: DRUG

Participants will receive a single intravenous dose of zampilimab at a pre-specified time point.

Placebo

Participants randomized to this arm will receive matching Placebo to maintain the blinding.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will receive matching placebo at a pre-specified time point to maintain the blinding.

Interventions

Zampilimab

Participants will receive a single intravenous dose of zampilimab at a pre-specified time point.

Intervention Type: DRUG

Placebo

Participants will receive matching placebo at a pre-specified time point to maintain the blinding.

Intervention Type: DRUG

Other Intervention Names

UCB7858; PBO

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UCB Biopharma SRL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: PRINCIPAL_INVESTIGATOR

001 844 599 2273 (UCB)

Locations

Up0105 001

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

2020-004411-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

UP0105

Identifier Type: -

Identifier Source: org_study_id