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CHS-1420

Phase 1

Healthy Participants | Monoclonal antibody | Other |Co-Diagnostics, Inc.|Last Updated: Jan 28, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment238
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07147257A Trial to Assess the Pharmacokinetic Similarity Between CHS-1420 40 mg/0.4 mL and HUMIRA® (Adalimumab) 40 mg/0.4 mL in Healthy Chinese Adult Participants Under Fasting ConditionsPHASE1 COMPLETED 238 — — Feb 12, 2025May 29, 2025Jan 28, 20261 China
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Study Endpoints
Primary Endpoints
Areas Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUC0-∞)
0 to 1536 hours post-dose

pre-dose (0 h) and at 2, 4, 8, 12,24,36,48,60,72,96,120,144,168,216,288,360,528,696,864,1032,1200,1368,1536h post-dose

The Maximum Serum Drug Concentration (Cmax)
0 to 1536 hours post-dose

pre-dose (0 h) and at 2, 4, 8, 12,24,36,48,60,72,96,120,144,168,216,288,360,528,696,864,1032,1200,1368,1536h post-dose

Secondary Endpoints
Areas Under the Serum Concentration Versus Time Curve Calculated to the Last Measurable Observation (AUC0-t)
0 to 1536 hours post-dose
Areas Under the Serum Concentration Versus Time Curve Calculated to 65 Days Postdose(AUC0-65days)
0 to 1536 hours post-dose
The Time to Maximum Serum Concentration(Tmax)
0 to 1536 hours post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
CHS-1420EXPERIMENTAL -
HUMIRA®ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
CHS-1420BIOLOGICALDose of 40 mg will be subcutaneously administered to participants in
HUMIRA®BIOLOGICALDose of 40 mg will be subcutaneously administered to participants in
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Able to provide signed Informed Consent Form before the trial, and fully understand the trial content, process and possible adverse drug reactions (ADRs) 2. Able to complete the trial in compliance with the protocol 3. Participants (including males) willing to adopt effective...

Countries:China
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