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CB-280

Phase 1

Cystic Fibrosis | Small Molecules | Respiratory |Calithera Biosciences, Inc|Trials Updated: Apr 13, 2022

CB-280 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

CB-280 clinical trials

CB-280 · 1 trial · 1 indication

Phase 1 1
NCT04279769Study to Evaluate the Safety of CB-280 in Patients With Cystic FibrosisCystic Fibrosis
COMPLETED32 Analytics
PHASE1COMPLETED
Study to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis
Cystic FibrosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Determine the safety and tolerability of CB-280 in adult cystic fibrosis patients: incidence and severity of adverse event (AEs) assessed by Common Terminology Criteria for Adverse Events, version 5 (CTCAE v5.0)
Start of treatment to Day 28

Secondary Endpoints

Pharmacokinetics of plasma CB-280 measured by Peak Plasma Concentration (Cmax)
Day 14
Pharmacokinetics of plasma CB-280 measured by area under the plasma concentration versus time curve, from time 0 to the last observed non-zero concentration (AUC 0-t)
Day 14
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALCB-280 twice daily at 50 mg for 14 days
Cohort 2EXPERIMENTALCB-280 twice daily at 100 mg for 14 days
Cohort 3EXPERIMENTALCB-280 twice daily at 200 mg for 14 days
Cohort 4EXPERIMENTALCB-280 twice daily at 400 mg for 14 days
PlaceboPLACEBO_COMPARATORPlacebo twice daily for 14 days

Interventions

NameTypeDescription
CB-280DRUGCB-280, oral capsule administered twice daily at the assigned dose level for 14 days
PlacebosDRUGPlacebo oral capsule administrated twice daily at the assigned dose level for 14 days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: 1. Written Informed Consent in accordance with federal, local, and institutional guidelines 2. Confirmed diagnosis of cystic fibrosis 3. Male or female subjects ≥ 18 years on the date of informed consent 4. Percent predicted FEV1 of 40-90% at screening per Global Lung Function I...

Countries:United StatesCanada
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Competitive Landscape -Cystic Fibrosis 20 trials