A Study in Healthy Japanese Participants to Evaluate the Safety and Pharmacokinetics of Otilimab

January 24, 2023 updated by: GlaxoSmithKline

A Single Center, Single Dose, Open-label Study in Healthy Japanese Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Otilimab

This study will assess the safety, tolerability and pharmacokinetics (PK) profiles of otilimab in healthy Japanese participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Participant must be 20 to 50 years of age inclusive, at the time of signing the informed consent.
  • Japanese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
  • A Coronavirus Disease-2019 (COVID-19) screening with negative test: Two consecutive approved molecular tests (Polymerase chain reaction [PCR] or antigen test) separated by greater than (>)24 hours. The second test should be within 72 hours of admission to the unit on Day -1.
  • Body mass index (BMI) within the range 18.5 to 24.9 kilograms per meter square (kg/m^2) (inclusive).

Exclusion Criteria:

  • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
  • Active infections (including localized infections), or history of recurrent infections (excluding recurrent fungal infections of the nail bed), or has required management of acute or chronic infections
  • History of any respiratory disease which (in the opinion of the investigator) would compromise participant safety or the ability of the participant to complete the study.
  • Clinically-significant or unstable (in the opinion of the investigator) persistent cough or dyspnea that is unexplained.
  • Current or previous active Tuberculosis (TB), history of untreated or incompletely treated active or latent TB, suspected or known extra pulmonary TB.
  • Previous close contact with a person with active TB and did not receive satisfactory anti-tuberculosis treatment as per World Health Organization (WHO) or national guidelines.
  • Hemoglobin less than or equal to (<=)9 grams per deciliter (g/dL); white blood cell (WBC) count <=3.0 times 10^9/ Liter (L); platelet count <=100 times 10^9/L; absolute neutrophil count (ANC) <=1.0 times 10^9/L; lymphocyte count <=0.75 times 10^9/L at screening.
  • A vaccination (live or attenuated) within 30 days prior to Day 1 or Bacillus Calmette-Guerin (BCG) vaccination within 365 days prior to Day 1, or a live vaccination planned during the course of the study. Any COVID-19 vaccination within 14 days prior to enrolment.
  • Any surgical procedure, including bone or joint surgery/synovectomy within 8 weeks prior to Day 1 or any planned surgery within the duration of the study.
  • Significant allergies to humanized Monoclonal antibody (mAb).
  • Participants with known COVID-19 positive contacts within 14 days prior to screening.
  • History of lymphoma, leukemia, or any malignancy.
  • History of infected joint prosthesis at any time, with the prosthesis still in situ. History of leg ulcers, catheters, chronic sinusitis or recurrent chest or urinary tract infections.
  • Use of prescription or non-prescription drugs within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before the start of study intervention until completion of the evaluation visit, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
  • Treatment with biologic agents (such as mAb including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
  • Blood donation/sampling within 60 days prior to screening.
  • The participant with positive Serological test for syphilis, Human immunodeficiency virus (HIV) antigen/antibody, or Human T-cell lymphotropic virus type 1 (HTLV-1) antibody.
  • The participant with positive test for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis B surface antibody (HBsAb), or Hepatitis C virus (HCV) antibody.
  • Positive pre-study drug/alcohol screen.
  • Participants with signs and symptoms suggestive of COVID-19 (fever, cough) within 14 days prior inpatient admission on Day -1.

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Healthy Japanese participants receiving otilimab
Biological: Otilimab
Otilimab will be administered via pre-filled syringe.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Maximum drug concentration (Cmax) following administration of otilimab
Time Frame: Up to 8 Weeks
Up to 8 Weeks
Area under the concentration-time curve from pre-dose to infinity (AUC[0-infinity]) following administration of otilimab
Time Frame: Up to 8 Weeks
Up to 8 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Area under the plasma concentration-time curve from pre-dose to t (AUC[0-t]) following administration of otilimab
Time Frame: Up to 8 Weeks
Up to 8 Weeks
Time to maximum plasma concentration (Tmax) following administration of otilimab
Time Frame: Up to 8 Weeks
Up to 8 Weeks
Elimination half-life (t1/2) following administration of otilimab
Time Frame: Up to 8 Weeks
Up to 8 Weeks
Time to reach the last quantifiable plasma concentration (Tlast) following administration of otilimab
Time Frame: Up to 8 Weeks
Up to 8 Weeks
Number of participants with Adverse events (AEs), Serious adverse events (SAEs) and Adverse events of special interests (AESIs)
Time Frame: Up to 8 weeks
Up to 8 weeks
Change from Baseline in hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count (Giga cells per liter)
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Change from Baseline in hematology parameter: Red blood cell (RBC) count (Trillion cells per liter)
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Change from Baseline in hematology parameter: Hemoglobin (Grams per Liter)
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Change from Baseline in hematology parameter: Hematocrit (Proportion of red blood cells in blood)
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Change from Baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters)
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Change from Baseline in hematology parameter: Mean corpuscular hemoglobin (MCH) (Picograms)
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Change from Baseline in hematology parameter: Percentage of reticulocytes (Percentage of reticulocytes)
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Change from Baseline in clinical chemistry parameters: Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase (AST), Creatine kinase, Gamma Glutamyl transferase (GGT), Lactate Dehydrogenase (International units per Liter)
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Change from Baseline in clinical chemistry parameters: Calcium, glucose, potassium, sodium, Chloride, Phosphate and Blood urea nitrogen (BUN) (Millimoles per Liter)
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Change from Baseline in clinical chemistry parameters: Creatinine, direct bilirubin, total bilirubin and uric acid (Micromoles per liter)
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Change from Baseline in clinical chemistry parameters: Albumin and Total protein (Grams per liter)
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Change from Baseline in clinical chemistry parameter: C-reactive protein (CRP) (Milligrams per liter
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Change from Baseline in clinical chemistry parameter: Amylase (Units per liter)
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Change from Baseline in lipid panel parameters: Total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol and triglycerides (Millimoles per Liter)
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Number of participants with abnormal urinalysis parameters by Dipstick Method
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Change from Baseline in vital signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) (Millimeters of mercury)
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Change from Baseline in vital sign: Pulse rate (Beats per minute)
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Change from Baseline in vital signs: Body temperature (Degrees Celsius)
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Change from Baseline in Electrocardiogram (ECG) parameters: PR interval, QRS duration, QT interval and corrected QT (QTc) interval (Milliseconds)
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Number of participants with anti-drug antibodies (ADAs) to otilimab
Time Frame: Up to Week 8
Up to Week 8
Number of participants with drug-neutralizing antibodies to otilimab
Time Frame: Up to Week 8
Up to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 8, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 4, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 208326

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

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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