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A Single-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Gantenerumab Following Subcutaneous (SC) Administration in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02711423
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This two-part study is designed to assess the safety, tolerability, and PK of gantenerumab in healthy volunteers. Part I (dose escalation) will randomly assign participants to receive a single blinded SC dose of gantenerumab or placebo. Part II (PK extension) will randomly assign participants to receive a single open-label SC dose of ganenerumab at different dose levels according to safety assessments from Part I.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: Gantenerumab Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single-Center, Randomized, Investigator/Subject-Blind Single-Ascending Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Gantenerumab Following SC Administration in Healthy Subjects
Actual Study Start Date : March 31, 2016
Actual Primary Completion Date : September 28, 2016
Actual Study Completion Date : September 28, 2016

Arm Intervention/treatment
Experimental: Part I (Dose Escalation): Gantenerumab
Participants will receive a single SC dose of gantenerumab on Day 1.
Drug: Gantenerumab
Gantenerumab will be supplied as a high-concentration liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1.
Placebo Comparator: Part I (Dose Escalation): Placebo
Participants will receive a single SC dose of matching placebo on Day 1.
Drug: Placebo
Placebo will be supplied as a matching liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1.
Experimental: Part II (PK Extension): Gantenerumab
Participants will receive a single SC dose of gantenerumab on Day 1. The dose range will be determined by safety and tolerability data collected from Part I.
Drug: Gantenerumab
Gantenerumab will be supplied as a high-concentration liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1.



Primary Outcome Measures :
  1. Percentage of participants with adverse events (AEs) [ Time Frame: Up to 12 weeks (from Baseline to Day 85 +/- 5 days) ]

Secondary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of gantenerumab [ Time Frame: Predose (0 hours) and 1, 6, and 12 hours from single dose administration; once daily from Days 2 to 10; and once daily on Days 12, 15, 21, 29, 43, 64, and 85 ]
  2. Area under the plasma concentration-time curve (AUC) of gantenerumab [ Time Frame: Predose (0 hours) and 1, 6, and 12 hours from single dose administration; once daily from Days 2 to 10; and once daily on Days 12, 15, 21, 29, 43, 64, and 85 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males 18 to 45 years of age, inclusive
  • Body mass index (BMI) 20.0 to 32.0 kilograms per meter-squared (kg/m^2), inclusive

Exclusion Criteria:

  • History of cancer or any clinically significant disease affecting one of the major organ systems
  • Prior administration of gantenerumab
  • Clinically significant laboratory test results
  • Clinically relevant history of hypersensitivity or allergic reaction following exposure to a drug, food, or environmental agent
  • Known hypersensitivity to gantenerumab or excipients of study drug formulation
  • Abnormal skin condition or potentially obscuring tattoo, pigmentation, or lesion in the area intended for SC injection
  • Familial history of early-onset Alzheimer's disease

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): NCT02711423


Locations
United States, Florida
Compass Research
Orlando, Florida, United States, 32806
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02711423     History of Changes
Other Study ID Numbers: BP30042
2015-005132-17 ( EudraCT Number )
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

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

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs