Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Freethiadine · 1 trial · 1 indication
Incidence of adverse events
Maximum plasma concentration of study drugs
Change from baseline in HBV DNA
| Arm | Type | Description |
|---|---|---|
| Freethiadine tablets | EXPERIMENTAL | part 1(Health volunteer): single-Dose Study: There will be a total of 5 dose cohorts: 5 mg、10 mg、200 mg(food effect)、400 mg、600 mg; multiple-dose study: 100 mg、200 mg、300 mg、150 mg |
| Freethiadine placebo tablets | PLACEBO_COMPARATOR | part 1(Health volunteer): single-Dose Study: There will be a total of 5 dose cohorts: 5 mg、10 mg、200 mg(food effect)、400 mg、600 mg; multiple-dose study: 100 mg、200 mg、300 mg、150 mg |
| Freethiadine tablet | EXPERIMENTAL | part 2(Patients with chronic hepatitis B): There will be a total of 4 dose cohorts:100 mg、200 mg(BID or QD)、300 mg |
| entecavir tablets | ACTIVE_COMPARATOR | part 2(Patients with chronic hepatitis B): 0.5 mg |
| Name | Type | Description |
|---|---|---|
| Freethiadine tablets(part I) | DRUG | Subjects will receive either a single dose of Freethiadine on Day 1 only (SAD HV), twice daily dosing of Freethiadine starting on Day 1 through Day 10 (MAD HV) |
| Freethiadine tablets (part II) | DRUG | once or twice daily for consecutive 28 days |
| Freethiadine placebo tablets | DRUG | Subjects will receive either a single dose of Freethiadine on Day 1 only (SAD HV), twice daily dosing of Freethiadine starting on Day 1 through Day 10 (MAD HV) |
| entecavir tablets | DRUG | once daily for consecutive 28 days |
Inclusion Criteria: Health volunteer: 1. Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions. 2. subjects and must be 18 to 45 years of age inclusive. 3. Body weight ≥ 45 kg and body mass index（BMI）between 18 an...
Freethiadine is an investigational small molecule being developed for the treatment of chronic Hepatitis B. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
Freethiadine is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker symbol SBFM.
Freethiadine is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. A Phase 1 study has been completed.
Freethiadine has one completed Phase 1 clinical trial, identified as NCT05391360. This study evaluated tolerance, pharmacokinetics, and antiviral activity in healthy subjects and patients with chronic Hepatitis B. The trial enrolled 128 participants in China.
No alternative names for Freethiadine have been disclosed. It is identified solely by its generic name, Freethiadine.