NCT05323110

Study of Intravenously Administered Anti-LIGHT Monoclonal Antibody CBS001 in Healthy Volunteers

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Capella Bioscience Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Chronic Inflammatory Disease

Interventions

Type	Name	Description
DRUG	CBS001	Intravenously administered, humanised anti-LIGHT IgG monoclonal antibody.
DRUG	Placebo	CBS001 matched placebo

Timeline

• Start date: 2022-04-14
• Primary completion: 2023-08-22
• Completion: 2023-08-22
• First posted: 2022-04-12
• Last updated: 2023-09-22

Locations

1 site across 1 country: United Kingdom