Rheumatoid ArthritisPhase 1NCT06213259
A Study of KD6005 in Healthy Participants and Participants With Rheumatoid Arthritis (RA)
A Phase 1 study testing KD6005 in people with Rheumatoid Arthritis, run by Shanghai Kanda Biotechnology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- KD6005
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2024to 10 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 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.
- 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 1987 or 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria.
Who cannot join
- 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 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.
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- Clinical symptoms, signs, laboratory tests or X-ray tests suggest active tuberculosis(TB).
- An infection that the investigators determined to be clinically significant occurred within 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 significant occurred 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 or required live vaccines during study participation, including within 28 days after the last 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 the investigator 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 rheumatoid arthritis secondary sjogren's syndrome and asymptomatic Hashimoto thyroiditis.
- Severe infection or acute or chronic infection in the 6 months prior to the initial study.
- History of latent or active granulomatous infection in the 6 months prior to screening.
- History of a non-tuberculous mycobacterium infection or an opportunistic infection within 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 to screening.
- Subjects who received live vaccine within 3 months prior to screening, or who will plan to receive live vaccine within 3 months from the first administration to the last administration of the KD6005.
- Treatment with small-molecule targeted drugs, such as JAK inhibitors, within 4 weeks prior to randomization.
- HBV screening includes HbsAg (surface antigen), anti-HBs (surface antibody) and anti-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 or wheelchair-bound for a long time.
- Subjects with arthritic diseases other than osteoarthritis.
- Subjects have depression or the significant suicide ideation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
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
- Being tested
- KD6005, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KD6005Drug
Biological: KD6005, SQ
PlaceboDrug
Placebo, SQ
| Study group | Role | What they receive |
|---|---|---|
| KD6005 (Healthy) | Experimental | Healthy participants will receive a single dose of KD6005 in dose escalation cohorts subcutaneously (SQ). Receives: Drug: KD6005 |
| Placebo (Healthy) | Placebo comparator | Healthy participants will receive a single dose of placebo, SQ. Receives: Drug: Placebo |
| KD6005(RA) | Experimental | Participants with RA will receive a multiple-dose of KD6005 in dose escalation cohorts, SQ. Receives: Drug: KD6005 |
| Placebo (RA) | Placebo comparator | Participants with RA will receive a multiple-dose of placebo, SQ. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a, and Phase 1b: The incidence and safety profile of participants with adverse events (AEs), serious adverse events(SAE)
To assess the safety and tolerability of KD6005 in healthy participants or Rheumatoid Arthritis (RA) participants.
Measured: Phase 1a: Through study completion, an average of 42 Days; Phase 1b: Through study completion, an average of 57 Days
Phase 1a, and Phase 1b: Percentage of Participants With Laboratory Abnormalities, that have clinical significance
Measured: Phase 1a: Through study completion, an average of 42 Days; Phase 1b: Through study completion, an average of 57 Days
Phase 1a: The Pharmacokinetics(PK) profile of KD6005: Maximum observed serum concentration (Cmax)
Measured: Through study completion, an average of 42 Days
Phase 1a: The Pharmacokinetics(PK) profile of KD6005: Time to reach maximum serum concentration (Tmax)
Measured: Through study completion, an average of 42 Days
Phase 1a: The Pharmacokinetics(PK) profile of KD6005: half-life (T1/2)
Measured: Through study completion, an average of 42 Days
Phase 1a: The Pharmacokinetics(PK) profile of KD6005: Area under blood concentration-time curve (AUC0-T and AUC0-∞)
Measured: Through study completion, an average of 42 Days
Phase 1a: The Pharmacokinetics(PK) profile of KD6005: Apparent volume of distribution (Vd)
Measured: Through study completion, an average of 42 Days
Phase 1a: The Pharmacokinetics(PK) profile of KD6005: Mean retention time (MRT)
Measured: Through study completion, an average of 42 Days
Secondary outcomes (15)
Phase 1a, and Phase 1b: The immunogenicity of KD6005
Including the incidence of ADA positive. For ADA positive patients, the incidence of neutralizing antibody (NAB) will be analyzed.
Measured: Phase 1a: Through study completion, an average of 42 Days; Phase 1b: Through study completion, an average of 57 Days
Phase 1b: The Pharmacokinetics(PK) profile of KD6005: Maximum observed serum concentration (Cmax)
Measured: Through study completion, an average of 57 Days
Phase 1b: The Pharmacokinetics(PK) profile of KD6005: Time to reach maximum serum concentration (Tmax)
Measured: Through study completion, an average of 57 Days
Phase 1b: The Pharmacokinetics(PK) profile of KD6005: half-life (T1/2)
Measured: Through study completion, an average of 57 Days
Phase 1b: The Pharmacokinetics(PK) profile of KD6005: Area under blood concentration-time curve (AUC0-T and AUC0-∞)
Measured: Through study completion, an average of 57 Days
Phase 1b: The Pharmacokinetics(PK) profile of KD6005: Apparent volume of distribution (Vd)
Measured: Through study completion, an average of 57 Days
Phase 1b: The Pharmacokinetics(PK) profile of KD6005: Mean retention time (MRT)
Measured: Through study completion, an average of 57 Days
Phase 1b: Change From Baseline in Erythrocyte sedimentation rate (ESR)
Preliminary pharmacodynamic evaluation in RA participants.
Measured: Through study completion, an average of 57 Days
Phase 1b: Change From Baseline in C-reactive protein (CRP)
Preliminary pharmacodynamic evaluation in RA participants.
Measured: Through study completion, an average of 57 Days
Phase 1b: Change From Baseline in anti-Cyclic citrullinated peptide antibody (anti-CCP)
Preliminary pharmacodynamic evaluation in RA participants.
Measured: Through study completion, an average of 57 Days
Phase 1b: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response
Preliminary pharmacodynamic evaluation in RA participants.
Measured: Through study completion, an average of 57 Days
Phase 1b: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50% Improvement (ACR50) Response
Preliminary pharmacodynamic evaluation in RA participants.
Measured: Through study completion, an average of 57 Days
Phase 1b: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70% Improvement (ACR70) Response
Preliminary pharmacodynamic evaluation in RA participants.
Measured: Through study completion, an average of 57 Days
Phase 1b: Change From Baseline in Disease Activity Score for 28 Joint Counts (DAS28) Using CRP
Preliminary pharmacodynamic evaluation in RA participants.
Measured: Through study completion, an average of 57 Days
Phase 1b: Change From Baseline in Disease Activity Score for 28 Joint Counts (DAS28) Using ESR
Preliminary pharmacodynamic evaluation in RA participants.
Measured: Through study completion, an average of 57 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start6 Jan 2024
- Primary completion10 Jan 2025
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Kanda Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yi Fang, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213259
- Sponsor's protocol ID
- KD6005CT01
- Status last verified
- Mar 2026
- First submitted
- 25 Dec 2023
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT06213259
- Acronym / sponsor ID
- KD6005CT01
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Shanghai Kanda Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| KD6005 (Healthy) | Experimental | Drug: KD6005Healthy participants will receive a single dose of KD6005 in dose escalation cohorts subcutaneously (SQ). |
| Placebo (Healthy) | Placebo comparator | Drug: PlaceboHealthy participants will receive a single dose of placebo, SQ. |
| KD6005(RA) | Experimental | Drug: KD6005Participants with RA will receive a multiple-dose of KD6005 in dose escalation cohorts, SQ. |
| Placebo (RA) | Placebo comparator | Drug: PlaceboParticipants with RA will receive a multiple-dose of placebo, SQ. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (39 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KD6005Biological: KD6005, SQ | Drug | KD6005 (Healthy), KD6005(RA) |
| PlaceboPlacebo, SQ | Drug | Placebo (Healthy), Placebo (RA) |
Primary outcome
Phase 1a, and Phase 1b: The incidence and safety profile of participants with adverse events (AEs), serious adverse events(SAE)
Time frame: Phase 1a: Through study completion, an average of 42 Days; Phase 1b: Through study completion, an average of 57 Days
To assess the safety and tolerability of KD6005 in healthy participants or Rheumatoid Arthritis (RA) participants.
Phase 1a, and Phase 1b: Percentage of Participants With Laboratory Abnormalities, that have clinical significance
Time frame: Phase 1a: Through study completion, an average of 42 Days; Phase 1b: Through study completion, an average of 57 Days
Phase 1a: The Pharmacokinetics(PK) profile of KD6005: Maximum observed serum concentration (Cmax)
Time frame: Through study completion, an average of 42 Days
Phase 1a: The Pharmacokinetics(PK) profile of KD6005: Time to reach maximum serum concentration (Tmax)
Time frame: Through study completion, an average of 42 Days
Phase 1a: The Pharmacokinetics(PK) profile of KD6005: half-life (T1/2)
Time frame: Through study completion, an average of 42 Days
Phase 1a: The Pharmacokinetics(PK) profile of KD6005: Area under blood concentration-time curve (AUC0-T and AUC0-∞)
Time frame: Through study completion, an average of 42 Days
Phase 1a: The Pharmacokinetics(PK) profile of KD6005: Apparent volume of distribution (Vd)
Time frame: Through study completion, an average of 42 Days
Phase 1a: The Pharmacokinetics(PK) profile of KD6005: Mean retention time (MRT)
Time frame: Through study completion, an average of 42 Days
15 secondary outcomes
Phase 1a, and Phase 1b: The immunogenicity of KD6005
Time frame: Phase 1a: Through study completion, an average of 42 Days; Phase 1b: Through study completion, an average of 57 Days
Phase 1b: The Pharmacokinetics(PK) profile of KD6005: Maximum observed serum concentration (Cmax)
Time frame: Through study completion, an average of 57 Days
Phase 1b: The Pharmacokinetics(PK) profile of KD6005: Time to reach maximum serum concentration (Tmax)
Time frame: Through study completion, an average of 57 Days
Phase 1b: The Pharmacokinetics(PK) profile of KD6005: half-life (T1/2)
Time frame: Through study completion, an average of 57 Days
Phase 1b: The Pharmacokinetics(PK) profile of KD6005: Area under blood concentration-time curve (AUC0-T and AUC0-∞)
Time frame: Through study completion, an average of 57 Days
Phase 1b: The Pharmacokinetics(PK) profile of KD6005: Apparent volume of distribution (Vd)
Time frame: Through study completion, an average of 57 Days
Phase 1b: The Pharmacokinetics(PK) profile of KD6005: Mean retention time (MRT)
Time frame: Through study completion, an average of 57 Days
Phase 1b: Change From Baseline in Erythrocyte sedimentation rate (ESR)
Time frame: Through study completion, an average of 57 Days
Phase 1b: Change From Baseline in C-reactive protein (CRP)
Time frame: Through study completion, an average of 57 Days
Phase 1b: Change From Baseline in anti-Cyclic citrullinated peptide antibody (anti-CCP)
Time frame: Through study completion, an average of 57 Days
Phase 1b: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response
Time frame: Through study completion, an average of 57 Days
Phase 1b: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50% Improvement (ACR50) Response
Time frame: Through study completion, an average of 57 Days
Phase 1b: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70% Improvement (ACR70) Response
Time frame: Through study completion, an average of 57 Days
Phase 1b: Change From Baseline in Disease Activity Score for 28 Joint Counts (DAS28) Using CRP
Time frame: Through study completion, an average of 57 Days
Phase 1b: Change From Baseline in Disease Activity Score for 28 Joint Counts (DAS28) Using ESR
Time frame: Through study completion, an average of 57 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Fang principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KD6005 in people with Rheumatoid Arthritis, run by Shanghai Kanda Biotechnology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a, and Phase 1b: The incidence and safety profile of participants with adverse events (AEs), serious adverse events(SAE) (time frame: Phase 1a: Through study completion, an average of 42 Days; Phase 1b: Through study completion, an average of 57 Days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.