Safety, Tolerability, PK, PD of Subcutaneous CSL730 in Healthy Adults
Research type
Research Study
Full title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects
IRAS ID
276099
Contact name
Pablo Forte Soto
Contact email
Sponsor organisation
CSL Behring GmBH
Eudract number
2019-001940-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 14 days
Research summary
This is a Phase I, randomised, double-blind, placebo-controlled study to assess safety, tolerability, PK and PD of single doses of CSL730 at rising dose levels. The main purpose of the study is to see if the study drug is safe and well-tolerated. The study will also investigate how CSL730 is taken up into the body, chemically broken down, distributed through the body, and excreted by the body (overall referred to as PK), and the effects of CSL730 on the body using biomarkers (referred to as PD). Subjects’ blood will be tested for possible antibodies against CSL730 that might have formed in the body after dosing.
Approximately 60 healthy male and female subjects will be enrolled in 10 study cohorts. Females must be of non-childbearing potential. The study includes a screening period, an in-house treatment period of 6 days and a follow-up period up to 8 weeks after dosing.
This is not a first-in-human study. To date, 26 healthy Caucasian subjects have received CSL730 or placebo intravenously in a Phase I study that was temporarily halted by the Sponsor due to adverse effects of cytokine release and elevated liver enzymes. To mitigate risk in this study, the study medication will be administered under the skin (subcutaneously). Sentinel dosing will be applied throughout. All available subject data will be assessed before a next cohort is started. In Cohorts 1-3, subjects will be premedicated for reasons described in the protocol. If deemed necessary for subject safety, subjects in the remaining cohorts may receive premedication.
The study drug is being developed for the treatment of autoimmune diseases, conditions in which the human body mistakenly produces antibodies that attack its own tissues. This results in inflammation and tissue damage. CSL730 aims to suppress this autoimmune response and thereby address the patient’s need for effective treatment.REC name
London - Hampstead Research Ethics Committee
REC reference
20/LO/0062
Date of REC Opinion
11 Mar 2020
REC opinion
Further Information Favourable Opinion