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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KD6005 (Healthy) | Experimental | Healthy participants will receive a single dose of KD6005 in dose escalation cohorts subcutaneously (SQ). |
|
| Placebo (Healthy) | Placebo Comparator | Healthy participants will receive a single dose of placebo, SQ. |
|
| KD6005(RA) | Experimental | Participants with RA will receive a multiple-dose of KD6005 in dose escalation cohorts, SQ. |
|
| Placebo (RA) | Placebo Comparator | Participants with RA will receive a multiple-dose of placebo, SQ. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KD6005 | Drug | Biological: KD6005, SQ |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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) | Through study completion, an average of 42 Days | |
| Phase 1a: The Pharmacokinetics(PK) profile of KD6005: Time to reach maximum serum concentration (Tmax) | Through study completion, an average of 42 Days | |
| Phase 1a: The Pharmacokinetics(PK) profile of KD6005: half-life (T1/2) | 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-∞) | Through study completion, an average of 42 Days | |
| Phase 1a: The Pharmacokinetics(PK) profile of KD6005: Apparent volume of distribution (Vd) | Through study completion, an average of 42 Days | |
| Phase 1a: The Pharmacokinetics(PK) profile of KD6005: Mean retention time (MRT) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
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Inclusion Criteria:
Main Inclusion Criteria for Healthy Participants (Phase 1a):
Main Inclusion Criteria for RA participants (Phase 1b):
Exclusion Criteria:
Main Exclusion Criteria for Healthy Participants (Phase 1a):
Main Exclusion Criteria for RA participants (Phase 1b):
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| Name | Affiliation | Role |
|---|---|---|
| Yi Fang | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Placebo |
| Drug |
Placebo, SQ |
|
| Through study completion, an average of 42 Days |
| Through study completion, an average of 57 Days |
| Phase 1b: The Pharmacokinetics(PK) profile of KD6005: Time to reach maximum serum concentration (Tmax) | Through study completion, an average of 57 Days |
| Phase 1b: The Pharmacokinetics(PK) profile of KD6005: half-life (T1/2) | 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-∞) | Through study completion, an average of 57 Days |
| Phase 1b: The Pharmacokinetics(PK) profile of KD6005: Apparent volume of distribution (Vd) | Through study completion, an average of 57 Days |
| Phase 1b: The Pharmacokinetics(PK) profile of KD6005: Mean retention time (MRT) | Through study completion, an average of 57 Days |
| Phase 1b: Change From Baseline in Erythrocyte sedimentation rate (ESR) | Preliminary pharmacodynamic evaluation in RA participants. | Through study completion, an average of 57 Days |
| Phase 1b: Change From Baseline in C-reactive protein (CRP) | Preliminary pharmacodynamic evaluation in RA participants. | 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. | 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. | 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. | 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. | 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. | 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. | Through study completion, an average of 57 Days |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |