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Yiqibuvir

Phase 1

Undisclosed | Small molecule | Other |Sunshine Biopharma Inc.|Trials Updated: Feb 21, 2024

Yiqibuvir target and mechanism

ModalitySmall molecule

Also known as [14C] Yiqibuvir

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Yiqibuvir clinical trials

Yiqibuvir · 1 trial · 1 indication

Phase 1 1
NCT05998304ADME Study of [14C] Yiqibuvir in Healthy Male SubjectsHealthy Male Subjects
COMPLETED8 Analytics
PHASE1COMPLETED
ADME Study of [14C] Yiqibuvir in Healthy Male Subjects
Healthy Male SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

Cumulative excretion of [14C] Yiqibuvir -related material (radioactivity in plasma, urine and fecal samples)
up to 18 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 Yiqibuvir
up to 18 days
Quantitive analysis of the concentrations of Yiqibuvir and main metabolites in plasma using the validated LC-MS/MS to obtain pharmacokinetic data
up to 18 days
Number of adverse events (AE) experienced by subjects
up to 18 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
[14C] YiqibuvirEXPERIMENTALEligible healthy male subjects received a single oral 600 mg (radioactivity of 100µCi) dose of \[14C\] Yiqibuvir

Interventions

NameTypeDescription
[14C] YiqibuvirDRUG600 mg suspension containing 100µCi of \[14C\] Yiqibuvir
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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 Yiqibuvir

What is Yiqibuvir?

Yiqibuvir is an investigational small molecule drug developed by Sunshine Biopharma Inc. (ticker SBFM). It has been studied in a Phase 1 clinical trial in healthy male subjects. The specific disease or condition it is intended to treat has not been disclosed.

Who is developing Yiqibuvir?

Yiqibuvir is being developed by Sunshine Biopharma Inc., which trades under the ticker symbol SBFM. The company sponsored a Phase 1 ADME study of the drug in healthy male subjects in China.

What phase is Yiqibuvir in?

Yiqibuvir is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA.

What clinical trials is Yiqibuvir in?

Yiqibuvir has been evaluated in one completed Phase 1 trial, NCT05998304, titled ADME Study of [14C] Yiqibuvir in Healthy Male Subjects. The trial enrolled 8 healthy male volunteers in China, was uncontrolled, and was not randomized or double blinded.

Is Yiqibuvir the same as [14C] Yiqibuvir?

Yes, [14C] Yiqibuvir is an alternative name for Yiqibuvir. The carbon-14 labeled form was used in the Phase 1 ADME study, NCT05998304, to track how the drug is absorbed, distributed, metabolized, and excreted in the body.