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

Phase 1

Completed

• Conditions: Hepatitis B Virus
• Interventions: Drug: RO7049389; Drug: Placebo

• Registration Number: NCT03570658
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-06-18
• Study First Submitted QC: 2018-06-18
• Study First Posted: 2018-06-27
• Study Start: 2018-08-24
• Primary Completion: 2019-01-28
• Study Completion: 2019-01-28
• Results First Submitted: 2020-01-23
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-17
• Last Update Submitted: 2020-02-17
• Results First Posted: 2020-02-28
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single-Ascending Dose (SAD)	RO7049389	Participants will receive a single dose of RO7049389.
Multiple-Ascending Dose (MAD)	RO7049389	Participants will receive multiple doses of RO7049389.
Placebo	Placebo	Participants will receive either a single dose (SAD cohorts) or multiple doses (MAD cohorts) of placebo matched to RO7049389.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events	From the date of first administered dose through 28 days after the last administered dose.	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Secondary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax) of RO7049389	At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)
Apparent Half-Life (T1/2) of RO7049389	At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)
Clearance (CL/F) of RO7049389	At pre-defined intervals on Day 1 (SAD)
Trough Plasma Concentration (Ctrough) of RO7049389	At pre-defined intervals on Day 14 (MAD)
Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration (AUClast) of RO7049389	At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)
Area Under the Plasma Concentration vs Time Curve Extrapolated to Infinity (AUC0-inf)	At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)
Time to Maximum Observed Plasma Concentration (Tmax) of RO7049389	At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)
Accumulation Index of RO7049389	At pre-defined intervals on Day 14 (MAD)
Area Under the Concentration vs Time Curve for a Dosing Interval (AUCtau)	At pre-defined intervals on Day 14 (MAD)

Trial Locations

Locations (1)

Huashan Hospital Affiliated to Fudan University; 🇨🇳 Shanghai City, China