Condition category
Signs and Symptoms
Date applied
06/08/2020
Date assigned
20/08/2020
Last edited
19/08/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://www.roche.com/about_roche/roche_worldwide.htm

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

Publication citations

Additional files

Editorial Notes

07/08/2020: Trial’s existence confirmed by the U.S. Food and Drug Administration.