Last updated: February 1, 2024
Sponsor: Shanghai Kanda Biotechnology Co., Ltd.
Overall Status: Active - Recruiting
Phase
1
Condition
Rheumatoid Arthritis
Musculoskeletal Diseases
Dermatomyositis (Connective Tissue Disease)
Treatment
KD6005
Placebo
Clinical Study ID
NCT06213259
KD6005CT01
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Main Inclusion Criteria for Healthy Participants (Phase 1a):
- 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 26kg/m2 inclusive and weigh at least 50kg for male , or at least 45kg female. In goodoverall health at the time of screening. Main Inclusion Criteria for RA participants (Phase 1b):
- Being voluntary to sign the informed consent form.
- Age 18-70 years old, and subjects with rheumatoid arthritis (RA) diagnosed by the 1987or 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria.
Exclusion
Exclusion Criteria: Main Exclusion Criteria for Healthy Participants (Phase 1a):
- Known to be allergic to KD6005 or its components.
- History of malignancy under study within 5 years, except adequately treated and curedbasal 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 disordersthat the investigator believes may confuse the study results or place the subject atundue risk.
- Subjects who are judged by the investigator to have a disease affecting drugabsorption, distribution, metabolism, and excretion; Or skin disease or other diseaseaffecting subcutaneous injection.
- Clinical symptoms, signs, laboratory tests or X-ray tests suggest activetuberculosis(TB).
- An infection that the investigators determined to be clinically significant occurredwithin 3 months prior to screening.
- Blood donation within the last 3 months (more than 400mL).
- Subjects who have participated in clinical trials of any drug or medical device within 3 months or 5 drug half-lives (whichever is longer) prior to screening.
- Any acute illness that the investigators determined to be clinically significantoccurred in the 1 month prior to screening.
- A history of severe herpes virus infection.
- A history of drug use or substance abuse.
- Subjects who received live/attenuated vaccine within 2 months prior to screening orrequired live vaccines during study participation, including within 28 days after thelast KD6005 administration.
- Received any medication within 4 weeks prior to use of KD6005.
- Subjects who have been tested positive for the following tests: Hepatitis B virus (HBV), Hepatitis C virus (HCV), human immunodeficiency virus (HIV).
- Pregnant or breastfeeding females.
- Smoke greater than 5 cigarettes/day.
- Alcoholism: Positive breath test for alcohol.
- Subjects who may not be able to complete the study for other reasons or who theinvestigator believes should not be included. Main Exclusion Criteria for RA participants (Phase 1b):
- History of congestive heart failure, including asymptomatic congestive heart failure.
- History of serious diseases of hepatic, renal and other important organs,hematological and endocrine system disorders.
- Subjects diagnosed with other rheumatic immune system diseases, except rheumatoidarthritis secondary sjogren's syndrome and asymptomatic Hashimoto thyroiditis.
- Severe infection or acute or chronic infection in the 6 months prior to the initialstudy.
- History of latent or active granulomatous infection in the 6 months prior toscreening.
- History of a non-tuberculous mycobacterium infection or an opportunistic infectionwithin 6 months prior to screening.
- Present or previous history of malignant tumor.
- Pregnant or breastfeeding females.
- Subjects who have participated in clinical trials of any drug within 3 months prior toscreening.
- Subjects who received live vaccine within 3 months prior to screening, or who willplan to receive live vaccine within 3 months from the first administration to the lastadministration of the KD6005.
- Treatment with small-molecule targeted drugs, such as JAK inhibitors, within 4 weeksprior to randomization.
- HBV screening includes HbsAg (surface antigen), anti-HBs (surface antibody) andanti-HBc (core antibody). Evidence of hepatitis B infection (positive for HBsAg).
- Subjects with a positive test for tuberculosis (TB).
- Subjects who have been tested positive for the following tests: Hepatitis C virus (HCV), human immunodeficiency virus (HIV).
- Known to be allergic to the KD6005.
- Subjects with a joint functional class IV or those who are bedridden orwheelchair-bound for a long time.
- Subjects with arthritic diseases other than osteoarthritis.
- Subjects have depression or the significant suicide ideation.
Study Design
Total Participants: 72
Treatment Group(s): 2
Primary Treatment: KD6005
Phase: 1
Study Start date:
January 06, 2024
Estimated Completion Date:
December 31, 2025
Connect with a study center
Peking University People's Hospital
Beijing,
ChinaActive - Recruiting
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