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

NCT03505190 | Completed Phase 1 Results

• 1 other identifier: YP39432
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (5)

• 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

  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.

  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.

  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.

  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.

  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

  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

  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

  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

  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

  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

Study Arms (5)

RO7062931 0.3mg/kg

EXPERIMENTAL

Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.

Drug: RO7062931; Drug: Placebo

RO7062931 1.0mg/kg

EXPERIMENTAL

Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.

Drug: RO7062931; Drug: Placebo

RO7062931 2.0mg/kg

EXPERIMENTAL

Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.

Drug: RO7062931; Drug: Placebo

RO7062931 4.0mg/kg

EXPERIMENTAL

Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.

Drug: RO7062931; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo.

Drug: Placebo

Interventions

RO7062931 DRUG

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.

RO7062931 0.3mg/kg; RO7062931 1.0mg/kg; RO7062931 2.0mg/kg; RO7062931 4.0mg/kg

Placebo DRUG

Matching placebo will be administered subcutaneously (SC).

Placebo; RO7062931 0.3mg/kg; RO7062931 1.0mg/kg; RO7062931 2.0mg/kg; RO7062931 4.0mg/kg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (2)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Location

MeSH Terms

Interventions

RO7062931

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: April 23, 2018
• Study Start: May 3, 2018
• Primary Completion: July 5, 2019
• Study Completion: July 5, 2019
• Last Updated: August 3, 2020
• Results First Posted: August 3, 2020

Record last verified: 2020-07

Locations

HK (2)