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Also known as Rademikibart, Rademikibart in prefilled syringe
CBP-201 · 4 trials · 4 indications
Treatment failure is defined as death due to any cause, (re)admission to a hospital for COPD, ED (re)visit or unscheduled medical visit for worsening of COPD symptoms, or the necessity to intensify pharmacologic treatment (including second course of systemic steroids for COPD exacerbation) within 28 days after randomization.
Treatment failure is defined as death due to any cause, (re)admission to a hospital for asthma, ED (re)visit or unscheduled medical visit for worsening of asthma symptoms, or the necessity to intensify pharmacologic treatment (including second course of systemic steroids for asthma exacerbation) within 28 days after randomization.
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 |
|---|---|---|
| Rademikibart | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 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 |
|---|---|---|
| Rademikibart | DRUG | Single 300 mg dose as a 2-minute IV push |
| Rademikibart in prefilled syringe | COMBINATION_PRODUCT | Participants receive 600 mg (4mL) of rademikibart administered subcutaneously. |
| Matching placebo in prefilled syringe | DRUG | Participants receive 4mL of placebo matched to rademikibart administered subcutaneously. |
| 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 - Asthma cohort * Body weight of ≥40 kg and BMI ≤45 kg/m2 at SV1a. * Physician-diagnosed asthma * Currently receiving treatment with low, medium, to high dose ICS in combination with at least 1 additional asthma controller medication. * Must have experienced at least 1 asthma exa...
CBP-201 is an investigational monoclonal antibody developed by Connect Biopharma Holdings Limited (ticker CNTB). It is being studied in clinical development and has been evaluated in a Phase 1 pharmacokinetics trial in healthy adult Chinese subjects. Its therapeutic indications have not been disclosed.
CBP-201 is developed by Connect Biopharma Holdings Limited, which trades under the ticker CNTB. The company is the sponsor of the clinical program studying the monoclonal antibody.
CBP-201 is in Phase 1 clinical development. It is investigational and has been studied in a completed Phase 1 trial. No later-phase trials are listed for this asset.
CBP-201 has been studied in one clinical trial, NCT05917782, titled A Study to Evaluate the Pharmacokinetics Similarity of CBP-201 in Healthy Adult Chinese Subjects. The Phase 1 trial was completed, enrolled 324 healthy adult participants in China, and used an active-controlled, randomized design.