A Study of KD6005 in Healthy Participants and Participants With Rheumatoid Arthritis (RA) - Trial NCT06213259
Access comprehensive clinical trial information for NCT06213259 through Pure Global AI's free database. This Phase 1 trial is sponsored by Shanghai Kanda Biotechnology Co., Ltd. and is currently Recruiting. The study focuses on Rheumatoid Arthritis. Target enrollment is 72 participants.
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Study Focus
Sponsor & Location
Shanghai Kanda Biotechnology Co., Ltd.
Timeline & Enrollment
Phase 1
Jan 06, 2024
Dec 01, 2025
Primary Outcome
Phase 1a, and Phase 1b: The incidence and safety profile of participants with adverse events (AEs), serious adverse events(SAE),Phase 1a, and Phase 1b: Percentage of Participants With Laboratory Abnormalities, that have clinical significance,Phase 1a: The Pharmacokinetics(PK) profile of KD6005: Maximum observed serum concentration (Cmax),Phase 1a: The Pharmacokinetics(PK) profile of KD6005: Time to reach maximum serum concentration (Tmax),Phase 1a: The Pharmacokinetics(PK) profile of KD6005: half-life (T1/2),Phase 1a: The Pharmacokinetics(PK) profile of KD6005: Area under blood concentration-time curve (AUC0-T and AUC0-∞),Phase 1a: The Pharmacokinetics(PK) profile of KD6005: Apparent volume of distribution (Vd),Phase 1a: The Pharmacokinetics(PK) profile of KD6005: Mean retention time (MRT)
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).
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06213259
Non-Device Trial