Plain English Summary
Background and study aims
The aim of this study is to test RO7303509 compared with placebo at different doses, to find out if it is safe and to understand the way people process the drug. A placebo looks like a drug but has no active ingredient.
Who can participate?
Healthy male and female volunteers aged 18 to 75 years, inclusive
What does the study involve?
Participants are randomly assigned to receive either RO7303509 or placebo as a single dose to determine the safety of the drug. The total maximum study duration on study for participants is about 85 days.
What are the possible benefits and risks of participating?
Participants are not expected to receive any direct benefits from the study, but the information that is learned may help other people in the future. RO7303509 has not yet been tested in humans. For this reason, the side effects of this drug are not known at this time.
Where is the study run from?
Alliance for Multispecialty Research, LLC (USA)
When is the study starting and how long is it expected to run for?
May 2020 to June 2022
Who is funding the study?
Genentech, Inc. (USA)
Who is the main contact?
Dr Katie Tuckwell
tuckwell.katie@gene.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Katie Tuckwell
ORCID ID
http://orcid.org/0000-0002-6918-822X
Contact details
Genentech
Inc.
1 DNA Way
South San Francisco
CA
94080
United States of America
+1 (0)650 467 7475
tuckwell.katie@gene.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
GA42285
Study information
Scientific title
A Phase Ia, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single-ascending doses of RO7303509 in healthy volunteers
Acronym
Study hypothesis
To assess the safety, tolerability and pharmacokinetics of single-ascending doses of R07303509 in healthy volunteers.
Ethics approval
Approved 12/08/2020, Advarra IRB (6940 Columbia Gateway Drive, Suite 110, Columbia, MD 21046, USA; +1 4108842900; no email provided), ref: none provided
Study design
Phase Ia randomized double-blind placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Inflammation
Intervention
Participants will be randomized to the treatment arms through an interactive voice or web-based response system (IxRS). In this single-ascending dose (SAD) study, each cohort will evaluate either IV or SC administration of RO7303509. The initial dose of RO7303509 will be 50 mg IV and the highest dose will be determined based on review of safety and PK data. All participants will reside at the clinical research unit for a minimum of 48 hours after dosing. Participants will then return for regularly scheduled non-residential follow-up visits through Day 85.
Intervention type
Drug
Phase
Phase I
Drug names
RO7303509
Primary outcome measure
The safety of single doses of RO7303509 according to the World Health Organization (WHO) Toxicity Grading Scale and vital signs, labs and ECG from baseline to day 85
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
01/05/2020
Overall trial end date
01/06/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age ≥ 18 years and ≤ 75 years
2. Ability to comply with the study protocol, in the investigator’s judgment
3. Use of contraceptive measures
Participant type
Healthy volunteer
Age group
Mixed
Gender
Both
Target number of participants
56
Participant exclusion criteria
1. Pregnant or breastfeeding, or intending to become pregnant during the study or within 85 days after the dose of RO7303509
2. No comorbid conditions that may interfere with the evaluation of an investigational medical product
3. No history or evidence of substance abuse that would pose a risk to participants safety, interfere with the conduct of the study, or have an impact on the study results
4. History of severe allergic or anaphylactic reactions to human, humanized, or Current treatment with medications that are well known to prolong the QT
Recruitment start date
01/09/2020
Recruitment end date
01/01/2022
Locations
Countries of recruitment
United States of America
Trial participating centre
Volunteer Research Group
37920
United States of America
Sponsor information
Organisation
Genentech, Inc.
Sponsor details
1 DNA Way
South San Francisco
94080
United States of America
+1 (0)888 662 6728
global.clinical_trial_registry@roche.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Genentech
Alternative name(s)
Genentech, Inc., Genentech Inc, Genentech USA Inc, The Genentech, Genentech Inc., Genentech USA, Inc., Genentech USA Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal approximately 1 year after the anticipated trial end date. Additional trial documents (i.e., study protocol) will not be made available.
IPD sharing statement
Data will not be shared to protect the privacy of trial participants.
Intention to publish date
01/06/2023
Participant level data
Not expected to be available
Basic results (scientific)
Publication list