NCT05328557

A Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 in Normal Healthy Volunteers

Phase Ia, Randomized Double-Blinded, Placebo-Controlled Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 Following a Single Dose Administration in Normal Health Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Cugene Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The intent of this study is to evaluate the safety and tolerability of single escalating subcutaneous doses of CUG252 in healthy adult subjects.

Detailed description

This is a Phase Ia study of CUG252, comprising a randomized, double-blind, placebo-controlled, single ascending dose in healthy adult subjects.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	CUG252	CUG252 will be administered by subcutaneous (SC) injection
DRUG	Placebo	Placebo will be administered by subcutaneous (SC) injection

Timeline

• Start date: 2021-11-09
• Primary completion: 2022-08-03
• Completion: 2022-08-03
• First posted: 2022-04-14
• Last updated: 2025-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study