Clinical trial NCT03505190: A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RO7062931 in Healthy Chinese Volunteers.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2018-04-23
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Percentage of Participants With Adverse Events and AEs of Special Interest
timeFrame: Up to 16 weeks
measure: Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results
timeFrame: Baseline, Day 2, 8, 15, 29, 85
measure: Percentage of Participants With Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85
measure: Percentage of Participants With T-wave Abnormalities
timeFrame: Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85
measure: Percentage of Participants With U-wave Abnormalities
timeFrame: Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax) for RO7062931
timeFrame: 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
measure: Time to Reach Maximum Plasma Concentration (Tmax) for RO7062931
timeFrame: 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
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) for RO7062931
timeFrame: 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
measure: Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) for RO7062931
timeFrame: 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
measure: Terminal Elimination Half-Life (t1/2) for RO7062931
timeFrame: 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
measure: Apparent Clearance (CL/F) for RO7062931
timeFrame: 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
measure: Apparent Volume of Distribution (Vz/F) for RO7062931
timeFrame: 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
measure: Cumulative Amount of RO7062931 Excreted in Urine (Ae)
timeFrame: (0-4), (4-8), (8-12), (12-24)h post-dose Day 1
measure: Fraction of Cumulative Amount of RO7062931 Excreted in the Urine Over Total Dose (Fe)
timeFrame: 0-24h h post-dose Day 1
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Shatin, New Territories
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References: