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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT02711423

Collaborator

(none)

Enrollment

Location

Arms

5.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Mar 31, 2016

Actual Primary Completion Date :

Sep 28, 2016

Actual Study Completion Date :

Sep 28, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Percentage of participants with adverse events (AEs) [Up to 12 weeks (from Baseline to Day 85 +/- 5 days)]

Secondary Outcome Measures

Maximum observed plasma concentration (Cmax) of gantenerumab [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]
Area under the plasma concentration-time curve (AUC) of gantenerumab [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bioclinica Research	Orlando	Florida	United States	32806

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT02711423

Other Study ID Numbers:

BP30042
2015-005132-17

First Posted:

Mar 17, 2016

Last Update Posted:

Apr 10, 2019

Last Verified:

Apr 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 10, 2019