A Double-Blind Single-Ascending Dose (SAD) and Multiple-Ascending Dose (MAD) Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7049389 in Healthy Chinese Participants

NCT ID: NCT03570658

Last Updated: 2020-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-24
• Study Completion Date: 2019-01-28

Brief Summary

This study will assess the safety and tolerability of RO7049389 compared to placebo in single- and multiple-ascending doses in healthy Chinese participants.

Conditions

Hepatitis B Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Single-Ascending Dose (SAD)

Participants will receive a single dose of RO7049389.

Group Type: EXPERIMENTAL

RO7049389

Intervention Type: DRUG

RO7049389 will be administered orally either as a single dose (SAD) or as multiple doses defined by the SAD portion of the study (MAD).

Multiple-Ascending Dose (MAD)

Participants will receive multiple doses of RO7049389.

Group Type: EXPERIMENTAL

RO7049389

Intervention Type: DRUG

RO7049389 will be administered orally either as a single dose (SAD) or as multiple doses defined by the SAD portion of the study (MAD).

Placebo

Participants will receive either a single dose (SAD cohorts) or multiple doses (MAD cohorts) of placebo matched to RO7049389.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered orally at a dose and frequency matched to RO7049389.

Interventions

RO7049389

RO7049389 will be administered orally either as a single dose (SAD) or as multiple doses defined by the SAD portion of the study (MAD).

Intervention Type: DRUG

Placebo

Placebo will be administered orally at a dose and frequency matched to RO7049389.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Chinese healthy male and female subjects, 18 to 60 years of age, inclusive.
• A Body Mass Index (BMI) of between 19 to 27 kg/m2 inclusive, and a body weight of at least 45 kg.
• Women should be of non-childbearing potential. Female subjects must be either surgically sterile (by means of hysterectomy and/or bilateral oophorectomy) or post-menopausal for at least one year (defined as amenorrhea >/=12 consecutive months without another cause, and confirmed by follicle stimulating hormone level >35 mIU/mL).
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm

Exclusion Criteria

• Pregnant (positive pregnancy test) or lactating women, and male subjects with partners who are pregnant or lactating.
• History or symptoms of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis.
• Personal history of congenital long QT syndrome or family history of sudden death.
• History of Gilbert's syndrome.
• History of having received or currently receiving any systemic anti-neoplastic (including radiation) or immune-modulatory treatment (including systemic oral or inhaled corticosteroids) </=6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
• Subjects who have had significant acute infection, e.g., influenza, local infection, acute gastrointestinal symptoms or any other clinically significant illness within two weeks of dose administration.
• Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable).
• Electrocardiogram (ECG) with QRS and/or T-wave judged to be unfavorable for a consistently accurate QT measurement (e.g., neuromuscular artifact that cannot be readily eliminated, arrhythmias, indistinct QTS onset, low amplitude T-wave, merged T- and U waves, prominent U-waves)
• Creatinine clearance (CrCl) </=70 mL/min (using the Cockcroft-Gault formula)
• Positive test at screening of any of the following: hepatitis A (HAV IgM Ab), hepatitis B (HBsAg), hepatitis C (HCV RNA or HCV Ab) or human immunodeficiency virus 1 and 2 (HIV Ab).
• Participation in an investigational drug or device study within 90 days prior to screening or more than 4 times per year.
• Donation or loss of blood over 500 mL within 3 months prior to screening.
• Any suspicion or history of drug and/or alcohol abuse within the last year.
• History (within 3 months of screening) of alcohol consumption exceeding two standard drinks per day on average (1 standard drink = 10 grams of alcohol). Alcohol consumption will be prohibited at least 48 hours before screening, 48 hours before and 48 hours after each dose, and 48 hours before each scheduled visit.
• Use of >5 cigarettes or equivalent nicotine-containing product per day.
• Taking any prescribed or over-the-counter medications (including vitamins or herbal remedies) within 2 weeks of first dosing or within 5 times the elimination half-life of the medication prior to first dosing (whichever is longer). Occasional acetaminophen/paracetamol is allowed.
• Subjects under judicial supervision, guardianship or curatorship.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Huashan Hospital Affiliated to Fudan University

Shanghai, , China

Countries

China

References

Wu X, Feng S, Zhang J, Zhang W, Zhang Y, Zhu M, Triyatni M, Zhao N, Bo Q, Jin Y. Evaluation of the safety, tolerability, and pharmacokinetics of RO7049389 in healthy Chinese volunteers. Clin Transl Sci. 2022 Jan;15(1):195-203. doi: 10.1111/cts.13134. Epub 2021 Sep 25.

Reference Type: DERIVED

PMID: 34562067 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

YP39406

Identifier Type: -

Identifier Source: org_study_id