NCT06213259

A Study of KD6005 in Healthy Participants and Participants With Rheumatoid Arthritis (RA)

A Phase 1, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Pharmacodynamics of KD6005 in Healthy Participants and Participants With Rheumatoid Arthritis (RA).

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Shanghai Kanda Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This phase 1 study will consist of two parts: Phase 1a is a single-dose study, and will evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary pharmacodynamics (PD) in healthy participants. Phase 1b is a multiple doses study, and will evaluate the safety, tolerability, PK and preliminary PD in participants with rheumatoid arthritis (RA).

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	KD6005	Biological: KD6005, SQ
DRUG	Placebo	Placebo, SQ

Timeline

• Start date: 2024-01-06
• Primary completion: 2025-01-10
• Completion: 2025-01-10
• First posted: 2024-01-19
• Last updated: 2026-04-01

Locations

1 site across 1 country: China