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Antaitavir Hasophate

Phase 1

Undisclosed | Small molecule | Other |Sunshine Biopharma Inc.|Trials Updated: Jan 5, 2023

Antaitavir Hasophate target and mechanism

ModalitySmall molecule

Also known as [14C] Antaitavir Hasophate

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Antaitavir Hasophate clinical trials

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?

Antaitavir Hasophate is an investigational small molecule developed by Sunshine Biopharma Inc. (ticker SBFM). It has been studied in a Phase 1 clinical trial, and its specific therapeutic indications have not been disclosed. It is not approved for any use.

Who is developing Antaitavir Hasophate?

Antaitavir Hasophate is being developed by Sunshine Biopharma Inc., which trades under the ticker SBFM. The company sponsored the Phase 1 trial of the drug.

What phase is Antaitavir Hasophate in?

Antaitavir Hasophate is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA or any other regulatory agency.

What clinical trials is Antaitavir Hasophate in?

Antaitavir Hasophate has been evaluated in one completed Phase 1 trial, NCT05446233, titled ADME Study of [14C] Antaitavir Hasophate in Healthy Male Subjects. The trial enrolled 6 healthy male participants in China and was an uncontrolled, non-randomized study.

Is Antaitavir Hasophate the same as [14C] Antaitavir Hasophate?

Yes, [14C] Antaitavir Hasophate is an alternative name for Antaitavir Hasophate. The bracketed label indicates a carbon-14 radiolabeled version used in the ADME study, NCT05446233, to track the drug's absorption, distribution, metabolism, and excretion.