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Yiqibuvir

Phase 1

Healthy Male Subjects | Small molecule | Other |Sunshine Biopharma Inc.|Last Updated: Feb 21, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

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 Subjects
NCT059983048
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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 used for?

Yiqibuvir is an investigational small molecule being studied in healthy male subjects. It is currently in Phase 1 clinical development, with a completed trial evaluating its absorption, distribution, metabolism, and excretion (ADME) in healthy volunteers. Yiqibuvir is not approved for any indication and remains in early-stage clinical testing.

Who makes Yiqibuvir?

Yiqibuvir 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 candidate in early-stage trials.

What phase is Yiqibuvir in?

Yiqibuvir is in Phase 1 clinical development. A Phase 1 study of the drug has been completed, and it remains an investigational agent. Yiqibuvir is not FDA approved and is still undergoing early clinical evaluation in healthy volunteers.

What clinical trials is Yiqibuvir in?

Yiqibuvir has one completed Phase 1 clinical trial registered as NCT05998304. This study was an ADME (absorption, distribution, metabolism, and excretion) trial of [14C] Yiqibuvir conducted in 8 healthy male subjects in China. The trial was uncontrolled and not randomized or double-blinded.

Is Yiqibuvir the same as [14C] Yiqibuvir?

Yiqibuvir is the base drug compound, while [14C] Yiqibuvir is a radiolabeled version of the same molecule used in the ADME study. The [14C] label allows researchers to track the drug's movement and metabolism in the body during the clinical trial.