NCT05173883

A Phase 1 Clinical Study of CU-20401 in Chinese Healthy Population

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Single Subcutaneous Injection of CU-20401 in Chinese Healthy Population

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Cutia Therapeutics（Wuxi）Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, Part I/2/3/4 Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of a single subcutaneous injection of CU-20401 in healthy Chinese population, and to recommend an appropriate dose for subsequent clinical studies.

Detailed description

In Part 1, 3 dose groups (dose group A1) were prespecified : 0.04 mg/dose; Dose Group A2 : 0.075 mg/dose; Dose Group A3 : 0.15 mg/dose). Eligible subjects were enrolled in the order from the low dose group to the high dose group (A1 → A2 → A3), and all subjects in the first dose group completed dosing.All examinations (vital signs, physical examination, laboratory tests, 12-lead ECG, abdominal wall color ultrasonography, etc.) will be performed during the dosing observation period and the follow-up period. Only after the investigator confirms that no subject meets the criteria for discontinuation of escalation, the next dose group can be started. Two subjects will be enrolled in each dose group for at least 24 h, and the remaining 4 subjects will not be enrolled until no safety events have occurred. Eligible subjects were sequentially enrolled in Dose Group B1 (0.075 mg/dose) and Dose Group B2 (0.10 mg/dose) to receive the established dose. All examinations (vital signs, physical examination, laboratory tests, 12-lead ECG, abdominal B-ultrasound, etc.) will be performed during the dosing observation period .All subjects may enter Part 3 of the study after the investigator confirms that all subjects have completed the visit on D7 and no intolerable safety events have occurred. The subject continued to receive subsequent follow-up (D14/D21/D29). Eligible subjects were sequentially enrolled in dose group C1 (0.075 mg/dose) and dose group C2 (0.10 mg/dose) to receive the established dose; doses were administered bilaterally with 12 injections on each side. All examinations (vital signs, physical examination, laboratory tests, 12-lead ECG, abdominal B-ultrasound, etc.) were performed during the dosing observation period. During the follow-up period, a visit on D7/D14/D21/D29/D56/D84 was required. After subjects in Part III have completed at least the visit on D29, and no intolerable safety events have occurred, Part IV of the study may be conducted in consultation with the investigator and the sponsor. Based on the available data, a dose of 0.12 mg/dose is tentatively proposed for Part 4 of the study, administered bilaterally with 12 injections on each side. The study procedures are the same as Part III.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	injection ，CU-20401	Subcutaneous injection，cohort A 6 sites
DRUG	injection ，placebo	Subcutaneous injection，just one site

Timeline

• Start date: 2021-12-20
• Primary completion: 2023-11-02
• Completion: 2023-11-02
• First posted: 2021-12-30
• Last updated: 2024-12-10

Locations

1 site across 1 country: China