Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Test drug: CBP-201 · 1 trial · 1 indication
Pharmacokinetics similarity evaluation for test drug T1, test drug T2 and reference drug R
Pharmacokinetics similarity evaluation for test drug T1, test drug T2 and reference drug R
Pharmacokinetics similarity evaluation for test drug T1, test drug T2 and reference drug R
| Arm | Type | Description |
|---|---|---|
| Test drug (T1): CBP-201 injection (pre-filled syringe, 150 mg/1 mL) | EXPERIMENTAL | Strength: pre-filled syringe, 150 mg/1 mL |
| Test drug (T2): CBP-201 injection (pre-filled syringe, 300 mg/2 mL) | EXPERIMENTAL | Strength: pre-filled syringe, 300 mg/2 mL |
| Reference drug (R): CBP-201 injection (vial, 150 mg/1 mL) | ACTIVE_COMPARATOR | Strength: vial, 150 mg/1 mL |
| Name | Type | Description |
|---|---|---|
| Test drug (T1): CBP-201 injection (pre-filled syringe, 150 mg/1 mL) | BIOLOGICAL | subcutaneous injection of 2 doses on Day 1 |
| Test drug (T2): CBP-201 injection (pre-filled syringe, 300 mg/2 mL) | BIOLOGICAL | subcutaneous injection of 1 dose on Day 1 |
| Reference drug (R): CBP-201 injection (vial, 150 mg/1 mL) | BIOLOGICAL | subcutaneous injection of 2 doses on Day 1 |
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...
CBP-201 is an investigational monoclonal antibody developed by Connect Biopharma Holdings Limited. It is being studied in healthy adult subjects, with a completed Phase 1 trial evaluating its pharmacokinetic similarity in healthy adult Chinese subjects.
CBP-201 is not yet approved for any indication. It is currently in clinical development, with a completed Phase 1 trial in healthy adult subjects. The study was designed to evaluate pharmacokinetic similarity, not to treat a specific disease.
CBP-201 is developed by Connect Biopharma Holdings Limited, which trades under the ticker CNTB. The company is responsible for the clinical development of this monoclonal antibody.
CBP-201 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. It remains an investigational drug and has not been approved by the FDA or any regulatory agency.
CBP-201 has been studied in one completed Phase 1 trial, NCT05917782, titled "A Study to Evaluate the Pharmacokinetics Similarity of CBP-201 in Healthy Adult Chinese Subjects." The trial enrolled 324 healthy adult participants in China and was active-controlled and randomized.