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Neurology and Therapy

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Open Access 24-04-2023 | Pharmacokinetics | ORIGINAL RESEARCH

Safety, Tolerability and Pharmacokinetics of Single-Dose Oral SYHA1402 in Healthy Chinese Subjects

Authors: Beibei Liang, Jin Wang, Guanxuanzi Zhang, Rui Wang, Yun Cai

Published in: Neurology and Therapy | Issue 3/2023

Abstract

Introduction

To assess the safety, tolerability and pharmacokinetics of a single dose of SYHA1402 in healthy Chinese subjects.

Methods

This was a randomized, double-blind, placebo-controlled, single-ascending dose study in healthy subjects. Subjects received a single dose of SYHA1402 25 mg, 50 mg, 100 mg, 200 mg, 400 mg or 800 mg, or matching placebo. Safety and tolerability were assessed throughout the study. The pharmacokinetic (PK) parameters of SYHA1402 were estimated using non-compartmental analysis.

Results

In all, 54 subjects were enrolled and completed the study. Specifically, there were no deaths, serious adverse events or withdrawals from study due to adverse events. All treatment-emergent adverse events were mild. The most common drug-related adverse event was sinus bradycardia. The time to maximum concentration ranged from 1.13 to 2.25 h, and the terminal elimination half-life range was 1.51–4.70 h. SYHA1402 exhibited nonlinear PK parameters with less than dose-proportional increases in exposure after single oral doses of 25 to 800 mg.

Conclusion

SYHA1402 administered as a single dose was well tolerated and safe over the dose range of 25–800 mg. More than 50% of the unchanged SYHA1402 was excreted in urine within the dose range of 25–100 mg.

Trial registration

NCT03988413 (https://www.clinicaltrials.gov/; registration date: 17 June 2019).

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Title: Safety, Tolerability and Pharmacokinetics of Single-Dose Oral SYHA1402 in Healthy Chinese Subjects
Authors: Beibei Liang
Jin Wang
Guanxuanzi Zhang
Rui Wang
Yun Cai
Publication date: 24-04-2023
Publisher: Springer Healthcare
Keyword: Pharmacokinetics
Published in: Neurology and Therapy / Issue 3/2023
Print ISSN: 2193-8253
Electronic ISSN: 2193-6536
DOI: https://doi.org/10.1007/s40120-023-00480-x

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Safety, Tolerability and Pharmacokinetics of Single-Dose Oral SYHA1402 in Healthy Chinese Subjects

Abstract

Introduction

Methods

Results

Conclusion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction

Methods

Results

Conclusion

Trial registration

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