A study to investigate the safety, tolerability, and processing by the body of RO7223280 following single-dose administration in healthy Chinese participants
| ISRCTN | ISRCTN60758609 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60758609 |
| Secondary identifying numbers | BP44069 |
- Submission date
- 02/02/2023
- Registration date
- 07/02/2023
- Last edited
- 03/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The study drug RO7223280 is being developed for the possible treatment of bacterial infection caused by the bacteria Acinetobacter baumannii. RO7223280 is an experimental drug, which means Health Authorities have not approved RO7223280 for treating any bacterial infection. This study aims to test the safety of RO7223280 at different dose levels and to find out the effects, good or bad, of RO7223280 on the study participants.
Who can participate?
Healthy Chinese males and females aged between 18 and 64 years old
What does the study involve?
Participants will have to be a part of the study for about 6 weeks (from screening to follow-up), which will be divided as follows:
Screening Period: To check if the participants are eligible for the study. This visit will occur up to 28 days before the study treatment administration.
Treatment Period (residential/in-house): The participant will need to come to the clinic 1 day before the treatment administration (Day –1) and stay in the clinic for 5 nights (from Day -1 to Day 5).
Participants will be randomly assigned to one of the treatment groups to receive one single IV dose of either 600 milligrams (mg), 1000 mg, or 1500 mg of RO7223280 or a placebo (a substance that looks like the study drug but contains no active medication) through a tube or cannula introduced into a vein in the arm (intravenous infusion) on Day 1 of the treatment period.
Follow-up: To check on the participant after treatment is finished. This visit will occur approximately 14 days after the last study treatment administration.
What are the possible benefits and risks of participating?
RO7223280 is being given purely for research purposes, it is not intended for participants to receive any benefit from it. Future patients may benefit from the information collected in this study.
Participants may experience side effects from the study treatment or procedure. The side effects can vary from mild to very serious and may be different from person to person. RO7223280 has had limited testing in humans and not all side effects are known at this time.
The most common side effect includes infusion-related reactions (e.g., itching, flushing, shortness of breath). Other side effects include headache and side effects that are associated with either patch from the device that is used to monitor the heart electrocardiogram (ECG) or from the needle used to inject the drug (e.g., skin swelling (inflammation), skin bruising).
There may be a risk in exposing an unborn child to the study treatment, and not all potential consequences are known at this time. Women and men must take precautions to avoid exposing an unborn child or a breastfed baby to the study treatment. Participants who are pregnant, become pregnant, or are currently breastfeeding cannot take part in this study.
Where is the study run from?
F. Hoffmann-La Roche Ltd (Switzerland)
When is the study starting and how long is it expected to run for?
May 2022 to May 2023
Who is funding the study?
F. Hoffmann-La Roche Ltd (USA)
Who is the main contact?
global-roche-genentech-trials@gene.com
Contact information
Public
Building 1
Grenzacherstrasse 124
Basel
CH-4070
Switzerland
| Phone | +1 888-662-6728 |
|---|---|
| global-roche-genentech-trials@gene.com |
Study information
| Study design | Phase I single-dose sponsor-open randomized 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 |
| Scientific title | A sponsor-open, randomized, placebo-controlled, phase I study to investigate the pharmacokinetics, safety, and tolerability of RO7223280 in healthy Chinese participants following single IV dose administration |
| Study objectives | The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of RO7223280, a novel narrow-spectrum antibiotic, administered intravenously (IV) to healthy Chinese participants to support further global clinical development of RO7223280. |
| Ethics approval(s) | Approved 18/11/2022, Ethics Review Committee of Huashan Hospital affiliated to Fudan University (No. 12, Urumqi Middle Road, Shanghai, 200040, China; 021-52888045; wucuiyun@fudan.edu.cn), ref: 2022M-017 |
| Health condition(s) or problem(s) studied | Healthy volunteers |
| Intervention | RO7223280: Participants in each cohort will receive a single dose of RO7223280 or a matching placebo, as an IV infusion, on Day 1 of the dosing period. The planned dose-escalation sequence is 600 milligrams (mg), 1000 mg and 1500mg. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | RO7223280 |
| Primary outcome measure | 1. Time to maximum plasma concentration (Tmax) of RO7223280 calculated using standard non-compartmental methods of analysis at pre-dose and multiple time-points post-dose from Day 1 up to Day 5 2. Maximum observed serum concentration (Cmax) of RO7223280 calculated using standard non-compartmental methods of analysis at pre-dose and multiple time-points post-dose from Day 1 up to Day 5 3. Time to the last measurable time point (Tlast) of RO7223280 calculated using standard non-compartmental methods of analysis at pre-dose and multiple time-points post-dose from Day 1 up to Day 5 4. Observed last measurable plasma concentration (Clast) of RO7223280 calculated using standard non-compartmental methods of analysis at pre-dose and multiple time-points post-dose from Day 1 up to Day 5 5. Area under the plasma concentration versus time curve from zero to the last measurable concentration (AUClast) of RO7223280 calculated using standard non-compartmental methods of analysis at pre-dose and multiple time-points post-dose from Day 1 up to Day 5 6. Area under the plasma concentration versus time curve from zero to 72 hours (AUC0-72) of RO7223280 calculated using standard non-compartmental methods of analysis at pre-dose and multiple time-points post-dose from Day 1 up to Day 5 7. Area under the plasma concentration versus time curve extrapolated to Infinity (AUCinf) of RO7223280 calculated using standard non-compartmental methods of analysis at pre-dose and multiple time-points post-dose from Day 1 up to Day 5 8. Terminal rate constant (λz) of RO7223280 calculated using standard non-compartmental methods of analysis at pre-dose and multiple time-points post-dose from Day 1 up to Day 5 9. Apparent terminal half-life (T1/2) of RO7223280 Calculated Using Standard Non-compartmental Methods of Analysis at Pre-dose and Multiple Time-points Post-dose from Day 1 up to Day 5 10. Total body clearance (CL) of RO7223280 calculated using standard non-compartmental methods of analysis at pre-dose and multiple time-points post-dose from Day 1 up to Day 5 11. Volume of distribution at steady-state (V of RO7223280 calculated using standard non-compartmental methods of analysis at pre-dose and multiple time-points post-dose from Day 1 up to Day 5 12. Amount of RO7223280 excreted (Ae) into urine calculated using standard non-compartmental methods of analysis at pre-dose and multiple time-points post-dose from Day 1 up to Day 4 13. Fraction of the dose of RO7223280 administered excreted (Fe) into urine calculated using standard non-compartmental methods of analysis at pre-dose and multiple time-points post-dose from Day 1 up to Day 4 14. Renal clearance (CLr) of RO7223280, calculated using standard non-compartmental methods of analysis at pre-dose and multiple time-points post-dose from Day 1 up to Day 4 15. Number of participants with adverse events (AEs) and severity of AEs determined according to National Cancer Institute common terminology criteria for adverse events version 5.0 (NCI CTCAE v5.0) from screening up to 14 days after the last study treatment administration (up to approximately 44 days) |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 16/05/2022 |
| Completion date | 19/05/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Participants aged 18 to 64 years inclusive at screening 2. Healthy Chinese males and females (women of non-childbearing potential [WONCBP]) participants 3. Body weight of at least 50 kilograms (kg) and body mass index (BMI) within the range of 18 to 32 kilograms per square meter (kg/m2) (inclusive) |
| Key exclusion criteria | 1. History or evidence of any medical condition potentially altering the absorption, metabolism, or elimination of drugs 2. History of malignancy 3. Vaccination is prohibited within two months prior to Day 1 4. Use of glucocorticoids and other immunosuppressive medications is prohibited within 30 days (or within five times the elimination half-life, whichever is longer), prior to Day 1 5. Participation in an investigational drug medicinal product or medical device study within 30 days prior to screening or within five times the elimination half-life if known, whichever is longer 6. Clinically significant abnormalities (as judged by the Investigator) in laboratory test results 7. Positive results on human immunodeficiency virus (HIV)-1, HIV-2, hepatitis B virus, or hepatitis C virus (HCV) tests (including hepatitis B surface antigen, HCV antibody, and HIV antigen/antibody tests at screening) |
| Date of first enrolment | 24/02/2023 |
| Date of final enrolment | 28/04/2023 |
Locations
Countries of recruitment
- China
Study participating centre
China
Sponsor information
Industry
Building 1
Grenzacherstrasse 124
Basel
CH-4070
Switzerland
| Phone | +1 888-662-6728 |
|---|---|
| global-roche-genentech-trials@gene.com | |
| Website | https://www.roche.com/about/ |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Hoffman-La Roche, F. Hoffmann-La Roche Ltd.
- Location
- Switzerland
Results and Publications
| Intention to publish date | 28/03/2024 |
|---|---|
| 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 |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study are not expected to be made available due to participant-level data not being a regulatory requirement. |
Editorial Notes
03/02/2023: Trial's existence confirmed by the Ethics Review Committee of Huashan Hospital affiliated with the Fudan University (China).
