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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).
Shanghai Kanda Biotechnology Co., Ltd.·Phase 1·ClinicalTrials.gov·drugRecruiting
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Study focus
Disease/Condition
Rheumatoid Arthritis
Drug/Device/Intervention
KD6005
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Shanghai Kanda Biotechnology Co., Ltd.
Location
Beijing, China
Timeline & enrollment
Phase
Phase 1
Start date
Jan 06, 2024
End date
Dec 01, 2025
Enrollment
72 participants
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
Rheumatoid arthritis, unspecifiedOther rheumatoid arthritisOther specified rheumatoid arthritisRheumatoid arthritis with involvement of other organs and systemsSeronegative rheumatoid arthritis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06213259
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.