Approval Probability
TA Base Rate
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Also known as Freethiadine tablets(part I)
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 developed by Sunshine Biopharma Inc. (ticker SBFM) for the treatment of chronic Hepatitis B. It is in Phase 1 clinical development and has been studied in a single completed trial conducted in China.
Freethiadine is being developed for chronic Hepatitis B, a viral infection of the liver. Its only clinical study to date enrolled patients with chronic Hepatitis B alongside healthy subjects to evaluate tolerance, pharmacokinetics, and antiviral activity.
Freethiadine is developed by Sunshine Biopharma Inc., which trades under the ticker SBFM. The company is the sponsor of the drug's clinical program in chronic Hepatitis B.
Freethiadine is in Phase 1 clinical development. It is investigational and has not been approved for any indication. One Phase 1 trial has been completed, and no trials are currently active.
Freethiadine has been studied in one completed Phase 1 trial, NCT05391360, titled Evaluation Freethiadine Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of I Phase of Study. It was randomized, double-blind, placebo-controlled, and enrolled 128 participants in China.
Yes, Freethiadine tablets(part I) is another name for Freethiadine. Both refer to the same investigational small molecule developed by Sunshine Biopharma Inc. for chronic Hepatitis B.