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Antaitavir Hasophate

Phase 1

Healthy Male Subjects | Small molecule | Other |Sunshine Biopharma Inc.|Last Updated: Jan 5, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

Antaitavir Hasophate · 1 trial · 1 indication

Phase 1 1
NCT05446233ADME Study of [14C] Antaitavir Hasophate in Healthy Male SubjectsHealthy Male Subjects
COMPLETED6 Analytics
PHASE1COMPLETED
ADME Study of [14C] Antaitavir Hasophate in Healthy Male Subjects
Healthy Male SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

Distribution ratio of total radioactivity in whole blood and plasma of [14C] Antaitavir Hasophate
up to 15 days

To investigate the pharmacokinetics of total radioactivity in plasma after oral \[14C\] Antaitavir Hasophate in healthy subjects, and the distribution ratio of total radioactivity in whole blood and plasma

Cumulative excretion of [14C] Antaitavir Hasophate -related material (radioactivity in plasma, urine and fecal samples)
up to 15 days

Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces.

Secondary Endpoints

Identification of the Proportion of different metabolites to determine biotransformation pathway of Antaitavir Hasophate
up to 15 days
Quantitive analysis of the concentrations of Antaitavir Hasophate and main metabolites in plasma using the validated LC-MS/MS to obtain pharmacokinetic data
up to 15 days
Number of adverse events (AE) experienced by subjects
up to 15 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
[14C] Antaitavir HasophateEXPERIMENTALEligible healthy male subjects received a single oral 100 mg (radioactivity of 200µCi) dose of \[14C\] Antaitavir Hasophate

Interventions

NameTypeDescription
[14C] Antaitavir HasophateDRUG100 mg suspension containing 200µCi of \[14C\] Antaitavir Hasophate
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Eligibility Criteria

Age Range18 Years to 40 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * signing of informed consent * Weight: Body mass index (BMI) is 19.0\~28.0 kg/m2 * Subjects are able to communicate well with the investigators and be able to complete the trial according to the process Exclusion Criteria: * Those who are known to have allergy history or alle...

Countries:China
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Frequently asked questions about Antaitavir Hasophate

What is Antaitavir Hasophate used for?

Antaitavir Hasophate is an investigational small molecule being studied in healthy male subjects. It is not approved for any disease and is currently in clinical development. The only completed trial was an ADME study, which evaluates how the drug is absorbed, distributed, metabolized, and excreted in the body.

Who makes Antaitavir Hasophate?

Antaitavir Hasophate is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker SBFM. The company is conducting clinical research on this investigational small molecule drug.

What phase is Antaitavir Hasophate in?

Antaitavir Hasophate is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under investigation.

What clinical trials is Antaitavir Hasophate in?

Antaitavir Hasophate has one completed Phase 1 clinical trial with the identifier NCT05446233. The study was an ADME study of [14C] Antaitavir Hasophate in healthy male subjects, conducted in China with 6 participants aged 18 years and older.

Is Antaitavir Hasophate FDA approved?

Antaitavir Hasophate is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial. The drug is still in clinical development and has not received regulatory approval for any use.