NCT06744868

A Single- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of THDBH120 Injection in Healthy Subjects

A Single- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of THDBH120 Injection in Healthy Subjects: A Randomized, Bouble-Blind, Placebo-Controlled Phase I Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study includes single-ascending dose cohorts (SAD cohorts) and multiple-ascending dose cohorts (MAD cohorts). The aim of this trial is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of THDBH120 injection in healthy patients.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	THDBH120 injection (SAD)	Participants received escalating single doses of THDBH120 by subcutaneous injection.
DRUG	Placebo of THDBH120 injection (SAD)	Participants received single dose of placebo by subcutaneous injection.
DRUG	THDBH120 injection (MAD)	Participants received multiple doses of THDBH120 once weekly for four weeks by subcutaneous injection.
DRUG	Placebo of THDBH120 injection (MAD)	Participants received placebo once weekly for four weeks by subcutaneous injection.

Timeline

• Start date: 2023-12-19
• Primary completion: 2024-09-22
• Completion: 2024-09-22
• First posted: 2024-12-20
• Last updated: 2024-12-27

Locations

1 site across 1 country: China