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Test drug: CBP-201

Phase 1

Healthy Adult Subjects | Monoclonal antibody | Other |Connect Biopharma Holdings Limited|Last Updated: Oct 31, 2023

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment324

FDA Designations

No designations recorded

Clinical trial landscape

Test drug: CBP-201 · 1 trial · 1 indication

Phase 1 1
NCT05917782A Study to Evaluate the Pharmacokinetics Similarity of CBP-201 in Healthy Adult Chinese SubjectsHealthy Adult Subjects
COMPLETED324 Analytics
PHASE1COMPLETED
A Study to Evaluate the Pharmacokinetics Similarity of CBP-201 in Healthy Adult Chinese Subjects
Healthy Adult Subjects
NCT05917782324
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Study Endpoints

Primary Endpoints

Cmax: Maximum concentration
Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

Pharmacokinetics similarity evaluation for test drug T1, test drug T2 and reference drug R

AUC0-t: Area under the plasma concentration-time curve from the start of administration to the last measurable concentration time point T
Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

Pharmacokinetics similarity evaluation for test drug T1, test drug T2 and reference drug R

AUC0-inf: Area under the plasma concentration-time curve from the start of administration to infinity
Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

Pharmacokinetics similarity evaluation for test drug T1, test drug T2 and reference drug R

Secondary Endpoints

Maximum concentration (Cmax)
Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose
Area under the plasma concentration-time curve from the start of administration to the last measurable concentration time point T (AUC0-t)
Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose
Area under the plasma concentration-time curve from the start of administration to infinity (AUC0-inf)
Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Test drug (T1): CBP-201 injection (pre-filled syringe, 150 mg/1 mL)EXPERIMENTALStrength: pre-filled syringe, 150 mg/1 mL
Test drug (T2): CBP-201 injection (pre-filled syringe, 300 mg/2 mL)EXPERIMENTALStrength: pre-filled syringe, 300 mg/2 mL
Reference drug (R): CBP-201 injection (vial, 150 mg/1 mL)ACTIVE_COMPARATORStrength: vial, 150 mg/1 mL

Interventions

NameTypeDescription
Test drug (T1): CBP-201 injection (pre-filled syringe, 150 mg/1 mL)BIOLOGICALsubcutaneous injection of 2 doses on Day 1
Test drug (T2): CBP-201 injection (pre-filled syringe, 300 mg/2 mL)BIOLOGICALsubcutaneous injection of 1 dose on Day 1
Reference drug (R): CBP-201 injection (vial, 150 mg/1 mL)BIOLOGICALsubcutaneous injection of 2 doses on Day 1
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Subjects who are to read, understand, and sign the ICF. 2. Healthy adult male or female subjects aged 18-45 years (inclusive) at screening, with each sex accounting for at least one-third of the overall sample size. 3. Body mass index (BMI) is between 19 and 28 kg/m2 (inclusi...

Countries:China
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