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

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ClinicalTrials.gov Identifier: NCT03505190
Recruitment Status : Completed
First Posted : April 23, 2018
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: RO7062931 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : May 3, 2018
Actual Primary Completion Date : July 5, 2019
Actual Study Completion Date : July 5, 2019

Arm Intervention/treatment
Experimental: Cohort 1
Eight participants will be administered subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931 and two participants will receive matching placebo.
Drug: RO7062931
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.

Drug: Placebo
Matching placebo will be administered subcutaneously (SC).

Experimental: Cohort 2
Eight participants will be administered subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931 and two participants will receive matching placebo.
Drug: RO7062931
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.

Drug: Placebo
Matching placebo will be administered subcutaneously (SC).

Experimental: Cohort 3
Eight participants will be administered subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931 and two participants will receive matching placebo.
Drug: RO7062931
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.

Drug: Placebo
Matching placebo will be administered subcutaneously (SC).

Experimental: Cohort 4
Eight participants will be administered subcutaneously (SC) 3.0 milligram per kilogram (mg/kg) of RO7062931 and two participants will receive matching placebo.
Drug: RO7062931
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.

Drug: Placebo
Matching placebo will be administered subcutaneously (SC).

Experimental: Cohort 5 (Optional)
Eight participants will be administered subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931 and two participants will receive matching placebo.
Drug: RO7062931
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.

Drug: Placebo
Matching placebo will be administered subcutaneously (SC).




Primary Outcome Measures :
  1. Percentage of participants with Adverse Events and AEs of Special Interest [ Time Frame: Up to 16 weeks ]
  2. Percentage of Participants with Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results [ Time Frame: Baseline, Day 2, 8, 15, 29, 85 ]
  3. 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 ]
  4. Percentage of Participants with Abnormalities in Vital Signs, Including Blood Pressure, Pulse Rate and Temperature [ Time Frame: Baseline; pre-dose, 1, 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 3, 4, 5, 6, 8, 15, 29, 85 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Terminal Elimination Rate Constant (k) 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 ]
  6. 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 ]
  7. 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 ]
  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 ]
  9. Cumulative Amount of RO7062931 Excreted in Urine (Ae) [ Time Frame: (0-4), (4-8), (8-12), (12-24)h post-dose Day 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505190


Locations
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Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Sponsors and Collaborators
Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03505190     History of Changes
Other Study ID Numbers: YP39432
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No