# Evaluation Freethiadine Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study

> **NCT05391360** · PHASE1 · COMPLETED · sponsor: **Sunshine Lake Pharma Co., Ltd.** · enrollment: 128 (actual)

## Conditions studied

- Hepatitis B, Chronic

## Interventions

- **DRUG:** Freethiadine tablets(part I)
- **DRUG:** Freethiadine tablets (part II)
- **DRUG:** Freethiadine placebo tablets
- **DRUG:** entecavir tablets

## Key facts

- **NCT ID:** NCT05391360
- **Lead sponsor:** Sunshine Lake Pharma Co., Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2021-10-11
- **Primary completion:** 2023-01-17
- **Final completion:** 2023-01-17
- **Target enrollment:** 128 (ACTUAL)
- **Last updated:** 2023-04-12


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05391360

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05391360, "Evaluation Freethiadine Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT05391360. Licensed CC0.

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