A Double-blind, Randomized, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Single- and Multiple-ascending Doses of Intravenously Administered Anti-LIGHT Monoclonal Antibody CBS001 in Healthy Volunteers

Capella Bioscience Ltd1 site in 1 country56 target enrollmentApril 14, 2022

ConditionsChronic Inflammatory Disease

InterventionsCBS001 Placebo

DrugsPlacebo CBS001

Overview

Phase: Phase 1
Intervention: CBS001
Conditions: Chronic Inflammatory Disease
Sponsor: Capella Bioscience Ltd
Enrollment: 56
Locations: 1
Primary Endpoint: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part B)
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A Phase 1, first in human (FIH), single-centre, double-blind, randomized, placebo-controlled, dose escalating trial to assess the safety and tolerability, pharmacokinetics (PK), immunogenicity and pharmacodynamics (PD) of CBS001 in healthy subjects. The study will be conducted in 2 parts:

Part A: Single ascending intravenous (IV) doses of CBS001 Part B: Multiple ascending IV doses of CBS001

Registry

clinicaltrials.gov

Start Date

April 14, 2022

End Date

August 22, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Capella Bioscience Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female healthy volunteer.
•Aged 18-65 years.
•A body mass index (BMI; Quetelet index) in the range 18.0-30.
•Body Mass Index = weight (kg)/(height\[m\]\^2
•Ability to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
•Willingness to give written consent to participate after reading the information and consent form (ICF), and after having the opportunity to discuss the trial with the investigator or their delegate.
•Agree to follow the contraception requirements of the trial
•Agree not to donate blood or blood products during the study and for up to 3 months after the administration of the trial medication or until the final follow-up visit (whichever is longer).
•Registered with a General Practitioner (GP) in the United Kingdom.
•Willingness to give written consent to have data entered into The Overvolunteering Prevention System (TOPS).

Exclusion Criteria

•Woman who is pregnant or lactating, or pre-menopausal woman who is sexually active and not using a reliable method of contraception.
•Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.
•Isolated bilirubin \> 1.5 x upper limit of normal (ULN). Isolated bilirubin \> 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is \< 35% indicative of Gilbert's syndrome.
•Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer's participation in the trial or make it unnecessarily hazardous.
•Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, allergic diseases such as asthma or atopic dermatitis requiring medication, or history of any psychotic mental illness.
•Presence or history of severe adverse reaction to any drug or a history of sensitivity to any CBS001 excipient.
•Use of a prescription medicine (except hormone contraceptives or hormone replacement therapy \[HRT\] in women) during the 28 days before the (first) dose of trial medication, or use of an over-the-counter medicine (except acetaminophen \[paracetamol\], dietary supplement, or herbal remedy) including St John's Wort during the 7 days before the (first) dose of trial medication.
•Receipt of an investigational product (including prescription medicines) as part of another clinical trial within the 3 months before \[first\] admission to this study; in the follow-up period of another clinical trial at the time of screening for this study.
•Receipt of an approved or investigational biological product within the 12 months before screening.
•Receipt of a vaccination (except COVID-19 vaccine) within 28 days before (first) dose of trial medication, or planned vaccination during the study.