NCT05917782

A Study to Evaluate the Pharmacokinetics Similarity of CBP-201 in Healthy Adult Chinese Subjects

A Randomized, Open-Label, Parallel-Designed, Phase I Clinical Study to Evaluate the Pharmacokinetics Similarity of Single-Dose CBP-201 Injection With Different Dosage Forms and Strengths in Healthy Adult Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 324 (actual)
• Sponsor: Connect Biopharm LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, randomized, open-label, single-dose, parallel-designed PK similarity study.

Detailed description

A total of 324 healthy subjects are planned to be enrolled and randomized into 3 groups at a ratio of 1:1:1, with 108 subjects in each group. They will receive 2 doses of the test drug T1 (CBP-201 injection (pre-filled syringe, 150 mg/1 mL)), 1 dose of the test drug T2 (CBP-201 injection (pre-filled syringe, 300 mg/2 mL)), and 2 doses of the reference drug R (CBP-201 injection (vial, 150 mg/1 mL)), respectively. The study consists of a screening period (Day-28 to Day-2), a baseline period (Day-1), an administration and observation period (Day1 to Day6), and a follow-up period (Day7 to Day57).

Conditions

• Healthy Adult Subjects

Interventions

Type	Name	Description
BIOLOGICAL	Test drug (T1): CBP-201 injection (pre-filled syringe, 150 mg/1 mL)	subcutaneous injection of 2 doses on Day 1
BIOLOGICAL	Test drug (T2): CBP-201 injection (pre-filled syringe, 300 mg/2 mL)	subcutaneous injection of 1 dose on Day 1
BIOLOGICAL	Reference drug (R): CBP-201 injection (vial, 150 mg/1 mL)	subcutaneous injection of 2 doses on Day 1

Timeline

• Start date: 2023-07-18
• Primary completion: 2023-10-06
• Completion: 2023-10-06
• First posted: 2023-06-26
• Last updated: 2023-10-31

Locations

1 site across 1 country: China