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Litapiprant

Phase 1

Asthma | Small molecule | Respiratory |Sunshine Biopharma Inc.|Trials Updated: Jul 27, 2020

Litapiprant target and mechanism

ModalitySmall molecule

Also known as Litapiprant Tablet

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Litapiprant clinical trials

Litapiprant · 1 trial · 1 indication

Phase 1 1
NCT03663686The Safety, Tolerability and Pharmacokinetic Study of Litapiprant Tablets in Healthy Male and Female SubjectsAsthma
COMPLETED60 Analytics
PHASE1COMPLETED
The Safety, Tolerability and Pharmacokinetic Study of Litapiprant Tablets in Healthy Male and Female Subjects
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse events
Baseline to day 8~10

To assess the safety and tolerability after a single dose of Litapiprant Tablets

Secondary Endpoints

AUC0-∞
Prior to dosing(0 hour)and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing
AUC0-t
Prior to dosing(0 hour)and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing
Cmax
Prior to dosing(0 hour)and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
25mg single dosesPLACEBO_COMPARATORIntervention Drug: 25mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
50mg single dosesPLACEBO_COMPARATORIntervention Drug: 50mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
100mg single dosesPLACEBO_COMPARATORIntervention Drug: 100mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
200mg single dosesPLACEBO_COMPARATORIntervention Drug: 200mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
400mg single dosesPLACEBO_COMPARATORIntervention Drug: 400mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
600mg single dosesPLACEBO_COMPARATORIntervention Drug: 600mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
800mg single dosesPLACEBO_COMPARATORIntervention Drug: 800mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily

Interventions

NameTypeDescription
Litapiprant TabletDRUGSmall molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female, overall healthy subjects,female VS male 1:1 ratio; * Between 18 and 45 years of age, inclusive, similar ages; * Body weight should be≥50 kg; Body Mass Index (BMI) is between 19.0 and 28.0 kg/m2, inclusive; * Able to comprehend and sign the ICF voluntarily prior...

Countries:China
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Frequently asked questions about Litapiprant

What is Litapiprant?

Litapiprant is an investigational small molecule drug being developed by Sunshine Biopharma Inc. (ticker SBFM) for asthma, a respiratory condition. It is in Phase 1 clinical development and has been studied in a completed Phase 1 trial in healthy volunteers.

What is Litapiprant used for?

Litapiprant is being developed for the treatment of asthma. It is an investigational therapy and has not been approved for any indication. The completed Phase 1 trial enrolled healthy volunteers rather than patients with asthma.

Who makes Litapiprant?

Litapiprant is being developed by Sunshine Biopharma Inc., which trades under the ticker symbol SBFM. The company is the sponsor of the clinical program for this investigational asthma drug.

What phase is Litapiprant in?

Litapiprant is in Phase 1 clinical 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 Litapiprant in?

Litapiprant has been evaluated in one completed Phase 1 trial, NCT03663686, titled a safety, tolerability and pharmacokinetic study of Litapiprant tablets in healthy male and female subjects. The trial enrolled 60 participants in China and was randomized, double-blind, and placebo-controlled.

Is Litapiprant the same as Litapiprant Tablet?

Yes, Litapiprant Tablet is an alternative name for Litapiprant. The Phase 1 trial NCT03663686 studied Litapiprant tablets, which is the oral tablet formulation of the investigational drug being developed by Sunshine Biopharma Inc. for asthma.