An Open-Label, Single-Dose Study to Assess the Pharmacokinetics and Target Engagement in Cerebral Spinal Fluid and Plasma Following a Single Intravenous Dose of Fremanezumab 900 mg in Healthy Subjects

Study identification

• EU PAS number:
  EUPAS103511
• Study ID:
  104846
• Official title and acronym:
  An Open-Label, Single-Dose Study to Assess the Pharmacokinetics and Target Engagement in Cerebral Spinal Fluid and Plasma Following a Single Intravenous Dose of Fremanezumab 900 mg in Healthy Subjects
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The goal of this study is to characterize the pharmacokinetics and target engagement of fremanezumab within cerebrospinal fluid (CSF) and plasma after single intravenous administration of a 900 mg dose of fremanezumab. The secondary objective is to evaluate the safety and tolerability of fremanezumab administered iv over a 1 hour infusion, and the exploratory objective is to characterize the relationship between fremanezumab exposure in plasma and CSF and fremanezumab-bound CGRP, inferring the effect of free CGRP. This study will be performed in healthy volunteers at a single site. Inclusion criteria includes being male or non-pregnant female ages 18-60 with no medical concerns, key exclusion criteria includes abnormalities in or around the spinal area, coagulation abnormailities, or use of a CGRP monoclonal antibody in the past 6 months. Study completion is expected April 2023. Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please visit www.clinicalstudydatarequest.com to make your request.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Juline Bryson

Study timelines

Date when funding contract was signed

Planned:10/02/2023

Actual:10/02/2023

Study start date

Planned:15/02/2023

Actual:15/02/2023

Date of final study report

Planned:09/11/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Teva Pharmaceuticals

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

TV48125-PK-10183