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

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ClinicalTrials.gov Identifier: NCT03764488
Recruitment Status : Not yet recruiting
First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: BIIB067 Drug: 99mTc-MAG3-BIIB067 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, Safety, Tolerability, and Distribution Study of a Microdose of Radiolabeled BIIB067 Co-administered With BIIB067 to Healthy Adults
Estimated Study Start Date : December 10, 2018
Estimated Primary Completion Date : December 2, 2019
Estimated Study Completion Date : December 2, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIIB067 Low Dose + 99mTc-MAG3-BIIB067 in 15 mL aCSF
Participants will receive intrathecal injection consisting of unlabeled BIIB067 and 99mTc-MAG3-BIIB067 in 15 mL aCSF.
Drug: BIIB067
Administered as specified in the treatment arm.

Drug: 99mTc-MAG3-BIIB067
Administered as specified in the treatment arm.

Experimental: BIIB067 Low Dose + 99mTc-MAG3-BIIB067 in 5 mL aCSF
Participants will receive intrathecal injection consisting of unlabeled BIIB067 and 99mTc-MAG3-BIIB067 in 5 mL aCSF.
Drug: BIIB067
Administered as specified in the treatment arm.

Drug: 99mTc-MAG3-BIIB067
Administered as specified in the treatment arm.

Experimental: BIIB067 Low Dose + 99mTc-MAG3-BIIB067 in 30 mL aCSF
Participants will receive intrathecal injection consisting of unlabeled BIIB067 and 99mTc-MAG3-BIIB067 in 30 mL aCSF.
Drug: BIIB067
Administered as specified in the treatment arm.

Drug: 99mTc-MAG3-BIIB067
Administered as specified in the treatment arm.

Experimental: BIIB067 High Dose + 99mTc-MAG3-BIIB067 in 15 mL aCSF
Participants will receive intrathecal injection consisting of unlabeled BIIB067 and 99mTc-MAG3-BIIB067 in 15 milliliter (mL) artificial cerebrospinal fluid (aCSF).
Drug: BIIB067
Administered as specified in the treatment arm.

Drug: 99mTc-MAG3-BIIB067
Administered as specified in the treatment arm.




Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Day 91 ]
    An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death, in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event), however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or is a medically important event.

  2. Dose of Radiation Absorbed (Dosimetry) in Specific Regions of the CNS [ Time Frame: 1 to 24 hours post-dose on Day 1 ]
    Dose of radiation absorbed (dosimetry) in specific regions of the CNS will be estimated by single-photon emission computed tomography (SPECT)/computed tomography (CT) imaging of 99mTc-MAG3-BIIB067.


Secondary Outcome Measures :
  1. BIIB067 Concentrations Throughout the CNS [ Time Frame: 1 to 24 hours post-dose on Day 1 ]
    BIIB067 concentrations throughout the CNS will be estimated by SPECT/CT imaging of 99mTc-MAG3-BIIB067.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03764488


Contacts
Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com

Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT03764488     History of Changes
Other Study ID Numbers: 233HV101
1709018566 ( Other Identifier: Weill Cornell Medicine eIRB )
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Technetium Tc 99m Mertiatide
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action