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

NCT05917782 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2023-10-31

No results posted yet for this study

Summary

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

Conditions

  • Healthy Adult Subjects

Interventions

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

Sponsors & Collaborators

  • Connect Biopharm LLC

    lead INDUSTRY

Principal Investigators

  • Suzhou Connect · Connect Biopharm LLC

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-18
Primary Completion
2023-10-06
Completion
2023-10-06

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05917782 on ClinicalTrials.gov