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KIN-1901

Phase 1

Inflammation | Small molecule | Immunology |Roivant Sciences Ltd.|Last Updated: Apr 13, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

KIN-1901 · 1 trial · 2 indications

Phase 1 1
NCT04205851Phase 1 Study With KIN-1901 in Healthy Subjects and Subjects With Ankylosing SpondylitisInflammation
COMPLETED36 Analytics
PHASE1COMPLETED
Phase 1 Study With KIN-1901 in Healthy Subjects and Subjects With Ankylosing Spondylitis
Inflammation
NCT0420585136
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Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events
Up to 57 days (Cohort 1 and 2); Up to 78 days (Cohorts 3, 4, and 5)
Change from baseline in QTcF interval
Up to 57 days (Cohort 1 and 2); Up to 78 days (Cohorts 3, 4, and 5)
Change in clinical chemistry parameter hsCRP determined by laboratory testing
Up to 57 days (Cohort 1 and 2); Up to 78 days (Cohorts 3, 4, and 5)
Incidence of serum anti-drug antibodies
Up to 57 days (Cohort 1 and 2); Up to 78 days (Cohorts 3, 4, and 5)

Secondary Endpoints

Serum Cmax
Up to 57 days (Cohort 1 and 2); Up to 78 days (Cohorts 3, 4, and 5)
Serum tmax
Up to 57 days (Cohort 1 and 2); Up to 78 days (Cohorts 3, 4, and 5)
Serum AUC
Up to 57 days (Cohort 1 and 2); Up to 78 days (Cohorts 3, 4, and 5)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
KIN-1901EXPERIMENTALSingle or repeat (once weekly for 4 weeks) KIN-1901 subcutaneous injection
PlaceboPLACEBO_COMPARATORSingle or repeat (once weekly for 4 weeks) placebo subcutaneous injection

Interventions

NameTypeDescription
KIN-1901DRUGKIN-1901 is a fully human monoclonal antibody (mAb).
PlaceboDRUGSaline
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Main Inclusion Criteria: 1. Capable of giving written informed consent, which includes compliance with study requirements and restrictions listed in the consent form. 2. Age requirements: * Cohorts 1 through 4 (healthy): Male or female age ≥ 18 years and ≤ 50 years. * Cohort 5 (AS): Male or ...

Countries:Canada
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Frequently asked questions about KIN-1901

What is KIN-1901 used for?

KIN-1901 is an investigational small molecule being developed for the treatment of inflammation. It is being studied in conditions such as rheumatic diseases, including ankylosing spondylitis. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes KIN-1901?

KIN-1901 is being developed by Roivant Sciences Ltd., a biopharmaceutical company traded on NASDAQ under the ticker symbol ROIV. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for inflammatory conditions.

What phase is KIN-1901 in?

KIN-1901 is in Phase 1 clinical development. A Phase 1 study has been completed, which involved healthy subjects and subjects with ankylosing spondylitis. The drug is investigational and has not received FDA approval or any other regulatory approval.

What clinical trials is KIN-1901 in?

KIN-1901 has one completed clinical trial registered as NCT04205851, titled "Phase 1 Study With KIN-1901 in Healthy Subjects and Subjects With Ankylosing Spondylitis." This randomized, double-blind, placebo-controlled study enrolled 36 participants in Canada and included healthy volunteers.

How does KIN-1901 work?

KIN-1901 is a small molecule designed to address inflammation, but its specific molecular target has not been disclosed. The drug is being evaluated for its potential to treat inflammatory and rheumatic diseases, including ankylosing spondylitis, through its anti-inflammatory properties.