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

NCT05323110 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-09-22

No results posted yet for this study

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

Interventions

DRUG

CBS001

Intravenously administered, humanised anti-LIGHT IgG monoclonal antibody.

DRUG

Placebo

CBS001 matched placebo

Sponsors & Collaborators

  • Centessa Pharmaceuticals plc

    collaborator INDUSTRY

  • Capella Bioscience Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-14
Primary Completion
2023-08-22
Completion
2023-08-22

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05323110 on ClinicalTrials.gov