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 type

• Study type:
  Clinical trial
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Pharmcakinetics/ Pharmacodynamics

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  FREMANEZUMAB

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
• Estimated number of subjects:
  25

Study design details

• Main study objective:
  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.
• Outcomes:
  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. To evaluate the safety and tolerability of fremanezumab administered iv over a 1 hour infusion
• Data analysis plan:
  Descriptive statistics (n, mean, standard deviation, standard error of mean, median, minimum, and maximum) will be provided for actual values