Single-Ascending-Dose Study of BIIB076 in Healthy Volunteers and Participants With Alzheimer's Disease

Phase 1

Completed

• Conditions: Alzheimer's Disease; Healthy Volunteer
• Interventions: Drug: BIIB076; Drug: Placebo

• Registration Number: NCT03056729
• Lead Sponsor: Biogen

Brief Summary

The primary objective of the study is to evaluate the safety and tolerability of single-ascending intravenous (IV) infusions of BIIB076 in healthy volunteers and participants with Alzheimer's disease (AD). A secondary objective of the study for both healthy volunteers and participants with AD is to assess the serum pharmacokinetic(s) (PK) profile of BIIB076 after single-dose administration. Another secondary objective is to evaluate the immunogenicity of BIIB076 in serum after single-dose administration.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-15
• Study Start: 2017-02-17
• Study First Posted: 2017-02-17
• Status Verified: 2020-03
• Primary Completion: 2020-03-03
• Study Completion: 2020-03-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort HV1	Placebo	-
Cohort HV2	Placebo	-
Cohort HV3	BIIB076	-
Cohort HV1	BIIB076	-
Cohort HV2	BIIB076	-
Cohort HV3	Placebo	-
Cohort HV4	Placebo	-
Cohort HV4	BIIB076	-
Cohort HV5	BIIB076	-
Cohort HV5	Placebo	-
Cohort AD1	BIIB076	-
Cohort AD1	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline up to Week 20	Safety surveillance

Secondary Outcome Measures

Name	Time	Method
BIIB076 serum pharmacokinetics (PK) concentration levels	Up to Week 20	Assessment of BIIB076 pharmacokinetics in blood
PK parameter of BIIB076: Area under the concentration-time curve from time zero to infinity (AUCinf)	Up to Week 20	Assessment of BIIB076 pharmacokinetics in blood
PK parameter of BIIB076: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)	Up to Week 20	Assessment of BIIB076 pharmacokinetics in blood
PK parameter of BIIB076: Maximum observed concentration (Cmax)	Up to Week 20	Assessment of BIIB076 pharmacokinetics in blood
PK parameter of BIIB076: Time to reach maximum observed concentration (Tmax)	Up to Week 20	Assessment of BIIB076 pharmacokinetics in blood
PK parameter of BIIB076: Terminal elimination half-life (t1/2)	Up to Week 20	Assessment of BIIB076 pharmacokinetics in blood
PK parameter of BIIB076: Clearance (CL)	Up to Week 20	Assessment of BIIB076 pharmacokinetics in blood
PK parameter of BIIB076: Volume of distribution (Vd)	Up to Week 20	Assessment of BIIB076 pharmacokinetics in blood
Number of participants with positive serum BIIB076 antibodies	Up to Week 20	Serological assessment (of anti-BIIB076 antibodies in blood)

Trial Locations

Locations (8)

St Louis Clinical Trial; 🇺🇸 Saint Louis, Missouri, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

MD Clinical; 🇺🇸 Hallandale Beach, Florida, United States

Progressive Medical Research; 🇺🇸 Port Orange, Florida, United States

Hawaii Pacific Neuroscience; 🇺🇸 Honolulu, Hawaii, United States

Covance Dallas CRU; 🇺🇸 Dallas, Texas, United States

Bioclinica Research; 🇺🇸 Orlando, Florida, United States

Covance CRU; 🇺🇸 Madison, Wisconsin, United States