A Study of KD6005 in Healthy Participants and Participants With Rheumatoid Arthritis (RA) (NCT06213259) | Clinical Trial Compass
CompletedPhase 1
A Study of KD6005 in Healthy Participants and Participants With Rheumatoid Arthritis (RA)
China73 participantsStarted 2024-01-06
Plain-language 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).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Being voluntary to sign the informed consent form.
✓. Male or female age 18 to 50 years. Have a body mass index (BMI) between 19 and 26 kg/m2 inclusive and weigh at least 50kg for male , or at least 45kg female. In good overall health at the time of screening.
✓. Being voluntary to sign the informed consent form.
✓. Age 18-70 years old, and subjects with rheumatoid arthritis (RA) diagnosed by the 1987 or 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria.
Exclusion criteria
✕. Known to be allergic to KD6005 or its components.
✕. History of malignancy under study within 5 years, except adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ.
✕. Subjects who had undergone any surgical procedures within 3 months prior to screening, or will plan surgery during the study period and within 1 month after the study ended.
✕. History of clinically significant cardiovascular, hepatic, neurological, respiratory, hematological, digestive, rheumatological, immune, renal, or psychiatric disorders that the investigator believes may confuse the study results or place the subject at undue risk.
✕. Subjects who are judged by the investigator to have a disease affecting drug absorption, distribution, metabolism, and excretion; Or skin disease or other disease affecting subcutaneous injection.
✕
What they're measuring
1
Phase 1a, and Phase 1b: The incidence and safety profile of participants with adverse events (AEs), serious adverse events(SAE)
Timeframe: Phase 1a: Through study completion, an average of 42 Days; Phase 1b: Through study completion, an average of 57 Days
2
Phase 1a, and Phase 1b: Percentage of Participants With Laboratory Abnormalities, that have clinical significance
Timeframe: Phase 1a: Through study completion, an average of 42 Days; Phase 1b: Through study completion, an average of 57 Days
3
Phase 1a: The Pharmacokinetics(PK) profile of KD6005: Maximum observed serum concentration (Cmax)
Timeframe: Through study completion, an average of 42 Days
4
Phase 1a: The Pharmacokinetics(PK) profile of KD6005: Time to reach maximum serum concentration (Tmax)
Timeframe: Through study completion, an average of 42 Days
5
Phase 1a: The Pharmacokinetics(PK) profile of KD6005: half-life (T1/2)
Timeframe: Through study completion, an average of 42 Days
6
Phase 1a: The Pharmacokinetics(PK) profile of KD6005: Area under blood concentration-time curve (AUC0-T and AUC0-∞)
Timeframe: Through study completion, an average of 42 Days