Phase 1
Completed N=28
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
Hepatitis B Virus
Source: ClinicalTrials.gov NCT03570658 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Percentage of Participants With Adverse Events — 16.7; 0; 30.0; 10.0 Percentage of Participants
Summary
This study will assess the safety and tolerability of RO7049389 compared to placebo in single- and multiple-ascending doses in healthy Chinese participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events |
16.7; 0; 30.0; 10.0; 50.0; 90.0 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of RO7049389 |
3840; 5220; 4020; 3230; 9210; 2730 | — |
| SECONDARY Time to Maximum Observed Plasma Concentration (Tmax) of RO7049389 |
1.5; 1.5; 2; 1.5; 2; 2 | — |
| SECONDARY Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration (AUClast) of RO7049389 |
5960; 12200; 10800; 5090; 19400; 5460 | — |
| SECONDARY Area Under the Plasma Concentration vs Time Curve Extrapolated to Infinity (AUC0-inf) |
9460; 12300; 11100; 5180; 19500; 5470 | — |
| SECONDARY Apparent Half-Life (T1/2) of RO7049389 |
3.66; 7.98; 10.4; 2.29; 1.62; 5.06 | — |
| SECONDARY Clearance (CL/F) of RO7049389 |
21.1; 32.6; 53.9 | — |
| SECONDARY Trough Plasma Concentration (Ctrough) of RO7049389 |
31.1; 66.1 | — |
| SECONDARY Accumulation Index of RO7049389 |
0.846; 0.872; 1.03; 1.05 | — |
| SECONDARY Area Under the Concentration vs Time Curve for a Dosing Interval (AUCtau) |
5090; 19400; 5230; 20400 | — |
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) 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.
Data sourced from ClinicalTrials.gov (NCT03570658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.