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



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 65
Updated:2/17/2019
Start Date:December 20, 2018
End Date:December 2, 2019
Contact:US Biogen Clinical Trial Center
Email:clinicaltrials@biogen.com
Phone:866-633-4636

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

This study will assess the safety and tolerability of 99mTc-MAG3-BIIB067 co-administered with
unlabeled BIIB067 to healthy participants and will also evaluate the distribution in the
central nervous system (CNS) of 99mTc-MAG3-BIIB067 co-administered with unlabeled BIIB067.


Key Inclusion Criteria:

- Must have a body mass index between 18 and 30 kilogram per square meter (kg/m^2),
inclusive.

- All men must practice highly effective contraception during the study and for 5 months
after their last dose of study treatment.

- All female participants must be of non-childbearing potential and must meet 1 of the
following criteria to participate in the study: a. Postmenopausal, b. History of
bilateral oophorectomy (performed at least 6 weeks prior to Screening), c. History of
hysterectomy (performed at least 6 weeks prior to Screening), or d. History of female
surgical sterilization (e.g., bilateral tubal ligation; performed at least 6 weeks
prior to Screening).

Key Exclusion Criteria:

- History of or ongoing clinically significant cardiac, endocrinologic, hematologic,
hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic,
psychiatric, renal, or other major disease, as determined by the Investigator.

- Clinically significant abnormal laboratory test values, as determined by the
Investigator, at Screening or Check-in.

- Use of any prescription medication, over-the-counter medication (e.g., aspirin and
nonsteroidal anti-inflammatory drugs [excluding acetaminophen]), or dietary and herbal
supplements (e.g., St. John's wort) within 28 days of Check-in and an unwillingness to
refrain from use through end of study (i.e., through the Day 91 visit), unless
specifically permitted elsewhere within the protocol.

- Current enrollment in any other drug, biologic, device, or clinical study, or
treatment with an investigational drug or approved therapy for investigational use
within 30 days (6 months for biologics) or 5 half-lives, whichever is longer, prior to
Check-in.

- History or physical examination that could be suggestive of a medical or mechanical
condition, disorder, or disease that could represent a relative contraindication to
lumbar puncture (LP), including but not limited to: (a) medication use that prolongs
coagulation times, including aspirin; (b) known disorders of the coagulation cascade,
platelet function, or platelet count; (c) low white blood cell counts; (d) chronic low
back pain; (e) prior lumbar spine surgery; (f) anatomical factors at or near the LP
site; (g) clinical signs of raised intracranial pressure (e.g., headache, papilledema,
or focal neurologic signs).

- Contraindications to radiation exposure for research purposes.

- Exposure to ionizing radiation within the last 12 months that would result in
approaching the exposure limits for healthy volunteers.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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