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

NCT05304130 | Withdrawn Phase 1

• 1 other identifier: 208326
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Arthritis, Rheumatoid

Keywords

Japanese participants; Otilimab; Pharmacokinetics; Rheumatoid arthritis; Safety; Tolerability

Outcome Measures

Primary Outcomes (2)

• Maximum drug concentration (Cmax) following administration of otilimab

  Up to 8 Weeks

• Area under the concentration-time curve from pre-dose to infinity (AUC[0-infinity]) following administration of otilimab

  Up to 8 Weeks

Secondary Outcomes (26)

• Area under the plasma concentration-time curve from pre-dose to t (AUC[0-t]) following administration of otilimab

  Up to 8 Weeks

• Time to maximum plasma concentration (Tmax) following administration of otilimab

  Up to 8 Weeks

• Elimination half-life (t1/2) following administration of otilimab

  Up to 8 Weeks

• Time to reach the last quantifiable plasma concentration (Tlast) following administration of otilimab

  Up to 8 Weeks

• Number of participants with Adverse events (AEs), Serious adverse events (SAEs) and Adverse events of special interests (AESIs)

  Up to 8 weeks

Study Arms (1)

Healthy Japanese participants receiving otilimab

EXPERIMENTAL

Biological: Otilimab

Interventions

Otilimab BIOLOGICAL

Otilimab will be administered via pre-filled syringe.

Healthy Japanese participants receiving otilimab

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Otilimab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible participants will receive treatment with otilimab.

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: February 8, 2023
• Primary Completion: May 4, 2023
• Study Completion: May 4, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.