A Single Ascending Dose Study to Investigate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Intravenously Administered RO7126209 in Healthy Participants

NCT04023994 | Completed Phase 1 Results FDA Drug

• 1 other identifier: BP41192
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Study BP41192 is a randomized, adaptive, placebo-controlled parallel group study to investigate the safety, tolerability, immunogenicity and pharmacokinetics of single-ascending intravenous (IV) doses of RO7126209 in healthy participants. RO7126209 is being developed for the treatment of Alzheimer's Disease.

Conditions

Alzheimers Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Events (AEs)

  An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events.

  Up to approximately 9 weeks

Secondary Outcomes (11)

• Concentration at the End of Infusion (Cend) of RO7126209

  Day 1

• Area Under the Plasma Concentration Versus Time Curve From Zero to 24 h Postdose (AUC0-24h) of RO7126209

  Days 1 and 2

• Area Under the Plasma Concentration Versus Time Curve From Zero to 168h Postdose (AUC0-168h) of RO7126209

  Days 1, 2, 3, 4, 5 and 8

• Area Under the Plasma Concentration Versus Time Curve From Zero to the Last Measurable Concentration (AUC0-last) of RO7126209

  Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57

• Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf)

  Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57

Study Arms (6)

Placebo

PLACEBO COMPARATOR

In Cohorts 1-5, there were ten participants in total who received placebo, two in each cohort.

Drug: Placebo

RO7126209 (0.1 mg/kg)

EXPERIMENTAL

Healthy volunteers will be administered a single intravenous dose of RO7126209 (0.1 mg/kg).

Drug: RO7126209

RO7126209 (0.4 mg/kg)

EXPERIMENTAL

Healthy volunteers will be administered a single intravenous dose of RO7126209 (0.4 mg/kg).

Drug: RO7126209

RO7126209 (1.2 mg/kg)

EXPERIMENTAL

Healthy volunteers will be administered a single intravenous dose of RO7126209 (1.2 mg/kg).

Drug: RO7126209

RO7126209 (3.6 mg/kg)

EXPERIMENTAL

Healthy volunteers will be administered a single intravenous dose of RO7126209 (3.6 mg/kg).

Drug: RO7126209

RO7126209 (7.2 mg/kg)

EXPERIMENTAL

Healthy volunteers will be administered a single intravenous dose of RO7126209 (7.2 mg/kg).

Drug: RO7126209

Interventions

RO7126209 DRUG

Participants will be administered single-ascending intravenous doses of RO7126209 with at least 2 weeks between each dose level. After the starting dose, the subsequent doses will be selected in an adaptive design. Sentinel dosing will be employed.

RO7126209 (0.1 mg/kg); RO7126209 (0.4 mg/kg); RO7126209 (1.2 mg/kg); RO7126209 (3.6 mg/kg); RO7126209 (7.2 mg/kg)

Placebo DRUG

Participants will be administered a single intravenous dose of matching placebo.

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy status is defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, ophthalmologic examination, hematology, blood chemistry, coagulation, serology, and urinalysis.
• Body mass index (BMI) of 18-30 kg/m2 inclusive
• During the treatment period and until the final follow up visit, agreement to: (1) Remain abstinent or use contraceptive measures such as a condom plus an additional contraceptive method that together result in a failure rate of \<1% per year, with a partner who is a woman of childbearing potential. (2) With pregnant female partner, remain abstinent or use contraceptive measures such as a condom to avoid exposing the embryo. (3) Refrain from donating sperm from Day 1 of the study until 90 days after last dose.

You may not qualify if:

• Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study.
• History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, ophthalmologic, hematological or allergic disease, metabolic disorder, cancer or cirrhosis.
• Any suspicion or history of alcohol abuse and/or suspicion of regular consumption of drug of abuse within the last 5 years.
• Positive result on hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV) 1 and 2.
• History or presence of clinically significant ECG abnormalities or cardiovascular disease.
• Clinically-significant abnormalities in laboratory test results.
• Any major illness within one month before the screening examination or any febrile illness within one week prior to screening and up to first dose administration.
• Impaired hepatic function as indicated by screening aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>=1.5 x the upper limit of normal (ULN) or abnormal total bilirubin unless due to Gilbert's disease.
• Any clinically relevant history of hypersensitivity or allergic reactions, either spontaneous or following drug administration, or exposure to foods or environmental agents.
• History of hypersensitivity to biologic agents or any of the excipients in the formulation.
• History of raised intra-cerebral pressure or vertebral joint pathology
• Use of prohibited medication or herbal remedies as described in the section of concomitant medications
• Prior administration of gantenerumab (RO4909832)
• Any vaccination within two months prior to Day 1
• Participation in an investigational drug medicinal product or medical device study within 30 days before screening or within seven times the elimination half-life if known, whichever is longer.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

PRA Health Sciences

Raleigh, North Carolina, 27612, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 18, 2019
• Study Start: August 3, 2019
• Primary Completion: July 17, 2020
• Study Completion: July 17, 2020
• Last Updated: August 9, 2021
• Results First Posted: August 9, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)