NCT07182656

Safety, Tolerability, and PK/PD of CIGB-814 in Chinese Health Participants

A Phase I Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Pharmacodynamics of Single and Multiple Doses of CIGB-814 in Healthy Participants

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Yi Fang · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of CIGB-814 for injection after single and multiple administrations in healthy participants. Secondary objectives include the assessment of preliminary pharmacodynamics (PD) and immunogenicity. Exploratory objectives are to investigate changes in immune cell subsets and signaling pathways following multiple administrations of CIGB-814.

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
DRUG	CIGB-814 (single-dose group)	CIGB-814, single ascending dose, SC injection
DRUG	CIGB-814 placebo (single-dose group)	CIGB-814 placebo, single ascending dose, SC injection
DRUG	CIGB-814 (multiple-dose group)	CIGB-814, multiple ascending dose, SC injection
DRUG	CIGB-814 placebo (multiple-dose group)	CIGB-814 placebo, multiple ascending dose, SC injection

Timeline

• Start date: 2025-08-18
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2025-09-19
• Last updated: 2025-09-19

Locations

1 site across 1 country: China