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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02711423
• Other study ID #: BP30042
• Secondary ID: 2015-005132-17
• Status: Completed
• Phase: Phase 1
• Start date: March 31, 2016
• Est. completion date: September 28, 2016

Study information

• Verified date: April 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 28, 2016
• Est. primary completion date: September 28, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

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
Placebo will be supplied as a matching liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1.

Locations

Country	Name	City	State
United States	Bioclinica Research	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with adverse events (AEs)		Up to 12 weeks (from Baseline to Day 85 +/- 5 days)
Secondary	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
Secondary	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