Phase 1
Completed N=41
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RO7062931 in Healthy Chinese Volunteers.
Healthy Participants
Source: ClinicalTrials.gov NCT03505190 ↗
Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Percentage of Participants With Adverse Events and AEs of Special Interest — 66.7; 62.5; 62.5; 75.0 Percentage of Participants
Summary
This randomized study will evaluate the safety, tolerability and pharmacokinetics of single ascending subcutaneously administered doses of RO7062931 in healthy volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events and AEs of Special Interest |
66.7; 62.5; 62.5; 75.0; 87.5; 0 | — |
| PRIMARY Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results |
11.1; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Electrocardiogram (ECG) Abnormalities |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With T-wave Abnormalities |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With U-wave Abnormalities |
22.2; 0; 0; 25.0; 0; 11.1 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) for RO7062931 |
17.71; 57.09; 113.52; 299.39 | — |
| SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) for RO7062931 |
1.50; 2.38; 2.87; 2.85 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) for RO7062931 |
95.26; 349.75; 791.99; 2180.74 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) for RO7062931 |
95.16; 348.33; 786.33; 2114.90 | — |
| SECONDARY Terminal Elimination Half-Life (t1/2) for RO7062931 |
3.87; 66.59; 81.83; 88.78 | — |
| SECONDARY Apparent Clearance (CL/F) for RO7062931 |
29.24; 27.23; 25.24; 17.46 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) for RO7062931 |
163.27; 2616.31; 2980.22; 2235.97 | — |
| SECONDARY Cumulative Amount of RO7062931 Excreted in Urine (Ae) |
35.35; 133.79; 326.90; 1433.92; 41.88; 147.88 | — |
| SECONDARY Fraction of Cumulative Amount of RO7062931 Excreted in the Urine Over Total Dose (Fe) |
1.50; 1.63; 2.79; 5.26 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT03505190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.