NCT03764488

A Study to Evaluate Safety, Tolerability, and Distribution of a Microdose of Radiolabeled BIIB067 (99mTc-MAG3-BIIB067) Co-administered With BIIB067 (Tofersen) to Healthy Adults

A Phase 1, Safety, Tolerability, and Distribution Study of a Microdose of Radiolabeled BIIB067 Co-administered With BIIB067 to Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to evaluate the distribution in the central nervous system (CNS) of a microdose 99mTc-MAG3-BIIB067 co-administered with unlabeled BIIB067 (Tofersen). The secondary objective of the study is to assess the safety and tolerability of unlabeled BIIB067 co-administered with a microdose of 99mTc-MAG3-BIIB067 to healthy participants.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Tofersen	Administered as specified in the treatment arm.
DRUG	99mTc-MAG3-BIIB067	Administered as specified in the treatment arm.

Timeline

• Start date: 2018-12-20
• Primary completion: 2021-06-10
• Completion: 2021-07-10
• First posted: 2018-12-05
• Last updated: 2023-06-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study