A study to evaluate the safety of RO7303509 in healthy volunteers
| ISRCTN | ISRCTN13175485 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13175485 |
| Secondary identifying numbers | GA42285 |
- Submission date
- 06/08/2020
- Registration date
- 20/08/2020
- Last edited
- 26/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
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 May 2022
Who is funding the study?
Genentech, Inc. (USA)
Who is the main contact?
global-roche-genentech-trials@gene.com
Contact information
Scientific
Genentech, Inc.
1 DNA Way
San Francisco
94080
United States of America
| Phone | +1 888-662-6728 |
|---|---|
| global-roche-genentech-trials@gene.com |
Study information
| Study design | Phase Ia randomized double-blind placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| Study objectives | To assess the safety, tolerability and pharmacokinetics of single-ascending doses of R07303509 in healthy volunteers. |
| Ethics approval(s) | Approved 12/08/2020, Advarra IRB (6940 Columbia Gateway Drive, Suite 110, Columbia, MD 21046, USA; +1 4108842900; no email provided), ref: none provided |
| Health condition(s) or problem(s) studied | Inflammation |
| Intervention | Current intervention as of 22/07/2022: 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 single doses of 150 mg IV (Cohort B), 240 mg IV (Cohort C), and 240 mg SC Cohort D) have been tested. Cohort E will receive 675 mg SC and the highest dose will be determined based on the review of safety, PK, and anti-drug antibody (ADA) data (if available) and will not exceed 1200 mg SC. 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. _____ Previous 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/05/2020 |
| Completion date | 19/05/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 57 |
| Total final enrolment | 57 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 29/09/2020 |
| Date of final enrolment | 24/02/2022 |
Locations
Countries of recruitment
- United States of America
Study participating centre
37920
United States of America
Sponsor information
Industry
1 DNA Way
South San Francisco
94080
United States of America
| Phone | +1 (0)888 662 6728 |
|---|---|
| global.clinical_trial_registry@roche.com | |
| Website | http://www.roche.com/about_roche/roche_worldwide.htm |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Genentech, Inc., Genentech USA, Inc., Genentech USA
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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 plan | Data will not be shared to protect the privacy of trial participants. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 25/04/2024 | 26/04/2024 | Yes | No |
Editorial Notes
26/04/2024: Publication reference added.
22/07/2022: The following changes have been made:
1. The recruitment start date has been changed from 01/09/2020 to 29/09/2020.
2. The recruitment end date has been changed from 01/01/2022 to 24/02/2022.
3. The overall trial end date has been changed from 01/06/2022 to 19/05/2022 and the plain English summary updated accordingly.
4. The intervention has been changed.
5. The target number of participants has been changed from 56 to 57.
6. The total final enrolment has been changed.
7. The trial participating centre has been changed from Volunteer Research Group to Alliance for Multispecialty Research LLC.
20/11/2020: The following changes were made to the trial record:
1. The contact was updated.
2. The plain English summary was updated to reflect these changes.
07/08/2020: Trial’s existence confirmed by the U.S. Food and Drug Administration.
