Healthy ParticipantsPhase 1NCT03505190

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RO7062931 in Healthy Chinese Volunteers.

A Phase 1 study testing RO7062931 in people with Healthy Participants, run by Hoffmann-La Roche at 2 sites in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This randomized study will evaluate the safety, tolerability and pharmacokinetics of single ascending subcutaneously administered doses of RO7062931 in healthy volunteers. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: RO7062931
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 41 participants
Where: 2 sitesHong Kong
Study dates: 3 May 2018to 5 Jul 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Chinese healthy male and female (of non-childbearing potential) volunteers.
A Body Mass Index (BMI) between 19 to 27 kilogram per square meter (kg/m2) inclusive and a body weight of at least 45 kg.
Women should be of non-childbearing potential. These include those who have undergone surgical sterilization (removal of ovaries and/or uterus) or are post-menopausal.
Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures during treatment and up to 105 days after the last dose of RO7062931, and agree to refrain from donating sperm during this same period.
Non-smoker (nor tobacco containing products) for at least 90 days prior to dosing on Day 1 and agree to remain as non-smoker during the study.

Who cannot join

History of drug or alcohol abuse or dependence in previous 6 months.
Positive urine drug and alcohol screen or positive cotinine test at Screening or Day -1.
Positive result on hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV)-1 and -2 at Screening.
Confirmed blood pressure or resting pulse rate outside of accepted ranges.
Participation in an investigational drug or device study within 90 days prior to screening.
Donation of blood over 500 milliliters (mL) within three months prior to screening.

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Any major illness within the one month, or any febrile illness within two weeks preceding the screening visit.
Alcohol consumption of more than 2 standard drinks per day on average.
Screening or baseline ECG evidence of atrial fibrillation, atrial flutter, complete right or left bundle branch block, Wolff-Parkinson-White syndrome, or cardiac pacemaker.
Any out of range findings in liver function tests, INR and renal function tests or any clinically significant abnormalities (as judged by the Investigator) in the physical examination and in the remaining laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis) at Screening or on Day-1.

Trial locations and contacts

2 sites in 1 country.

Hong Kong2 sites

Queen Mary Hospital
Hong Kong
Prince of Wales Hospital
Shatin, New Territories

Other trials in Hong Kong

About this study

Official title: A Randomized, Sponsor-Open, Investigator-Blind, Subject-Blind, Placebo-Controlled, Single Ascending Dose, to Investigate the Safety, Tolerability and Pharmacokinetics of RO7062931 Following Subcutaneously Administration in Healthy Chinese Volunteers

This randomized study will evaluate the safety, tolerability and pharmacokinetics of single ascending subcutaneously administered doses of RO7062931 in healthy volunteers.

Conditions: Healthy Participants
Being tested: RO7062931, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RO7062931Drug
RO7062931 will be administered SC in single ascending doses with starting of 0.3 mg/kg and subsequent doses of 1.0 mg/kg, 2.0 mg/kg and 3.0 mg/kg, respectively. Additional (optional) dose of 4.0 mg/kg may be administered based on safety, tolerability and PK data.
PlaceboDrug
Matching placebo will be administered subcutaneously (SC).

Study groups in NCT03505190
Study group	Role	What they receive
RO7062931 0.3mg/kg	Experimental	Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931. Receives: Drug: RO7062931; Drug: Placebo
RO7062931 1.0mg/kg	Experimental	Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931. Receives: Drug: RO7062931; Drug: Placebo
RO7062931 2.0mg/kg	Experimental	Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931. Receives: Drug: RO7062931; Drug: Placebo
RO7062931 4.0mg/kg	Experimental	Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931. Receives: Drug: RO7062931; Drug: Placebo
Placebo	Placebo comparator	Participants will receive matching placebo. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Adverse Events and AEs of Special Interest
Adverse events of special interest for this study include the following:
- Cases of an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice
- Suspected transmission of an infectious agent by the study drug
- Severe injection site reactions
- Renal adverse events
Measured: Up to 16 weeks
Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results
Marked reference range has been predefined for each laboratory parameter. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range that also represent a defined change from baseline will be considered marked laboratory abnormalities (i.e., potentially clinically relevant). If a baseline value is not available for a study subject, the midpoint of the standard reference range will be used as the study participant baseline value for the purposes of determining marked laboratory abnormalities.
Measured: Baseline, Day 2, 8, 15, 29, 85
Percentage of Participants With Electrocardiogram (ECG) Abnormalities
Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Measured: Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85
Percentage of Participants With T-wave Abnormalities
Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Measured: Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85
Percentage of Participants With U-wave Abnormalities
Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Measured: Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85

Secondary outcomes (9)

Maximum Plasma Concentration (Cmax) for RO7062931
Observed Maximum Plasma Concentration were obtained after the participants received the RO7062931
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8
Time to Reach Maximum Plasma Concentration (Tmax) for RO7062931
Time to reach the observed Maximum Plasma Concentration were obtained after the participants received the RO7062931.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) for RO7062931
Area Under the Plasma Concentration-time Curve Extrapolated to infinity was calculated based on Non-Compartment Analysis.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8
Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) for RO7062931
Area Under the Plasma Concentration-time Curve up to the last measurable concentration was calculated based on Non-Compartment Analysis
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8
Terminal Elimination Half-Life (t1/2) for RO7062931
Terminal Half-life was calculated based on Non-Compartment Analysis.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8
Apparent Clearance (CL/F) for RO7062931
Apparent oral clearance was calculated from Dose/AUCinf.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8
Apparent Volume of Distribution (Vz/F) for RO7062931
Apparent volume of distribution was calculated from Dose/AUCinf
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8
Cumulative Amount of RO7062931 Excreted in Urine (Ae)
Ae: cumulative amount of drug excreted in urine over a 24 hour period or over defined time periods linked to the pools of urine collected.
Measured: (0-4), (4-8), (8-12), (12-24)h post-dose Day 1
Fraction of Cumulative Amount of RO7062931 Excreted in the Urine Over Total Dose (Fe)
The fraction of cumulative amount in urine were calculated based on Ae/Dose
Measured: 0-24h h post-dose Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 May 20185 Jul 2019

First posted23 Apr 2018
Study start3 May 2018
Primary completion5 Jul 2019
Study completion5 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03505190
Sponsor's protocol ID: YP39432
Status last verified: Jul 2020
First submitted: 13 Apr 2018
Last updated: 3 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Sponsor-Open, Investigator-Blind, Subject-Blind, Placebo-Controlled, Single Ascending Dose, to Investigate the Safety, Tolerability and Pharmacokinetics of RO7062931 Following Subcutaneously Administration in Healthy Chinese Volunteers
ClinicalTrials.gov ID: NCT03505190
Acronym / sponsor ID: YP39432
Conditions: Healthy Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 3 May 2018 (actual)
Primary completion: 5 Jul 2019 (actual)
Study completion: 5 Jul 2019 (actual)
First posted: 23 Apr 2018 (actual)
Results: Posted 3 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This randomized study will evaluate the safety, tolerability and pharmacokinetics of single ascending subcutaneously administered doses of RO7062931 in healthy volunteers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
RO7062931 0.3mg/kg	Experimental	Drug: RO7062931, Drug: PlaceboParticipants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
RO7062931 1.0mg/kg	Experimental	Drug: RO7062931, Drug: PlaceboParticipants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
RO7062931 2.0mg/kg	Experimental	Drug: RO7062931, Drug: PlaceboParticipants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
RO7062931 4.0mg/kg	Experimental	Drug: RO7062931, Drug: PlaceboParticipants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive matching placebo.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Chinese healthy male and female (of non-childbearing potential) volunteers.
A Body Mass Index (BMI) between 19 to 27 kilogram per square meter (kg/m2) inclusive and a body weight of at least 45 kg.
Women should be of non-childbearing potential. These include those who have undergone surgical sterilization (removal of ovaries and/or uterus) or are post-menopausal.
Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures during treatment and up to 105 days after the last dose of RO7062931, and agree to refrain from donating sperm during this same period.
Non-smoker (nor tobacco containing products) for at least 90 days prior to dosing on Day 1 and agree to remain as non-smoker during the study.

Key exclusion criteria (10 listed)

History of drug or alcohol abuse or dependence in previous 6 months.
Positive urine drug and alcohol screen or positive cotinine test at Screening or Day -1.
Positive result on hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV)-1 and -2 at Screening.
Confirmed blood pressure or resting pulse rate outside of accepted ranges.
Participation in an investigational drug or device study within 90 days prior to screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RO7062931RO7062931 will be administered SC in single ascending doses with starting of 0.3 mg/kg and subsequent doses of 1.0 mg/kg, 2.0 mg/kg and 3.0 mg/kg, respectively. Additional (optional) dose of 4.0 mg/kg may be administered based on safety, tolerability and PK data.	Drug	RO7062931 0.3mg/kg, RO7062931 1.0mg/kg, RO7062931 2.0mg/kg, RO7062931 4.0mg/kg
PlaceboMatching placebo will be administered subcutaneously (SC).	Drug	Placebo, RO7062931 0.3mg/kg, RO7062931 1.0mg/kg, RO7062931 2.0mg/kg, RO7062931 4.0mg/kg

Primary outcome

Percentage of Participants With Adverse Events and AEs of Special Interest
Time frame: Up to 16 weeks
Adverse events of special interest for this study include the following: * Cases of an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice * Suspected transmission of an infectious agent by the study drug * Severe injection site reactions * Renal adverse events
Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results
Time frame: Baseline, Day 2, 8, 15, 29, 85
Marked reference range has been predefined for each laboratory parameter. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range that also represent a defined change from baseline will be considered marked laboratory abnormalities (i.e., potentially clinically relevant). If a baseline value is not available for a study subject, the midpoint of the standard reference range will be used as the study participant baseline value for the purposes of determining marked laboratory abnormalities.
Percentage of Participants With Electrocardiogram (ECG) Abnormalities
Time frame: Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85
Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Percentage of Participants With T-wave Abnormalities
Time frame: Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85
Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Percentage of Participants With U-wave Abnormalities
Time frame: Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85
Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.

9 secondary outcomes

Maximum Plasma Concentration (Cmax) for RO7062931
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8
Time to Reach Maximum Plasma Concentration (Tmax) for RO7062931
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) for RO7062931
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8
Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) for RO7062931
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8
Terminal Elimination Half-Life (t1/2) for RO7062931
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8
Apparent Clearance (CL/F) for RO7062931
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8
Apparent Volume of Distribution (Vz/F) for RO7062931
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8
Cumulative Amount of RO7062931 Excreted in Urine (Ae)
Time frame: (0-4), (4-8), (8-12), (12-24)h post-dose Day 1
Fraction of Cumulative Amount of RO7062931 Excreted in the Urine Over Total Dose (Fe)
Time frame: 0-24h h post-dose Day 1

Results and safety

Results posted to the registry on 3 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RO7062931 0.3mg/kg	9	9
RO7062931 1.0mg/kg	8	8
RO7062931 2.0mg/kg	8	8
RO7062931 4.0mg/kg	8	8
Placebo	8	8

Primary outcome: Percentage of Participants With Adverse Events and AEs of Special Interest

Time frame: Up to 16 weeks. Number. Unit: Percentage of Participants

Measure	RO7062931 0.3mg/kg n = 9	RO7062931 1.0mg/kg n = 8	RO7062931 2.0mg/kg n = 8	RO7062931 4.0mg/kg n = 8	Placebo n = 8
Adverse Events	66.7	62.5	62.5	75.0	87.5
Adverse Events of Special interest (AESI)	0	0	0	0	0

Population analysed: The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not.

Primary outcome: Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results

Time frame: Baseline, Day 2, 8, 15, 29, 85. Number. Unit: Percentage of Participants

Measure	RO7062931 0.3mg/kg n = 9	RO7062931 2.0mg/kg n = 8	Placebo n = 8
SGOT/AST High	11.1	0	0
Neutrophils, Total, Abs, Low	0	12.5	0
Triglycerides High	0	12.5	12.5

Population analysed: The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not.

Primary outcome: Percentage of Participants With Electrocardiogram (ECG) Abnormalities

Time frame: Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85. Number. Unit: Percentage of Participants

Measure	RO7062931 0.3mg/kg n = 9	RO7062931 1.0mg/kg n = 8	Placebo n = 8
Heart Rate Low	0	0	0
Heart Rate High	0	0	0
PR Duration Low	11.1	0	12.5
PR Duration High	0	25.0	25.0
QRS Duration Low	0	0	0
QRS Duration High	0	0	0
QT Duration Low	0	0	0
QT Duration High	0	0	0

Population analysed: The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not.

Primary outcome: Percentage of Participants With T-wave Abnormalities

Time frame: Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85. Number. Unit: Percentage of Participants

Measure	RO7062931 0.3mg/kg n = 9	RO7062931 1.0mg/kg n = 8	RO7062931 2.0mg/kg n = 8	RO7062931 4.0mg/kg n = 8	Placebo n = 8
Baseline Normal	0	0	0	0	0
Day 1 / 1H	0	0	0	0	0
Day 1 / 4H	0	0	0	0	0
Day 1 / 8H	0	0	0	0	0
Day 1 / 12H	0	0	0	0	0
Day 2 / 24H	0	0	0	0	0
Day 8 / 168H	0	0	0	0	0
Follow-up Visit Day 15	0	0	0	0	0

Population analysed: The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 14 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RO7062931 0.3mg/kg	0 of 9 (0%)	6 of 9 (66.7%)	0 of 9
RO7062931 1.0mg/kg	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8
RO7062931 2.0mg/kg	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8
RO7062931 4.0mg/kg	0 of 8 (0%)	6 of 8 (75%)	0 of 8
Placebo	0 of 8 (0%)	7 of 8 (87.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RO7062931 in people with Healthy Participants, run by Hoffmann-La Roche at 2 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events and AEs of Special Interest (time frame: Up to 16 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03505190.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.