Rheumatoid Arthritis
Conditions
Brief 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).
Interventions
DRUGKD6005
Biological: KD6005, SQ
DRUGPlacebo
Placebo, SQ
Sponsors
Shanghai Kanda Biotechnology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Main Inclusion Criteria for Healthy Participants (Phase 1a): 1. Being voluntary to sign the informed consent form. 2. 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): 1. Being voluntary to sign the informed consent form. 2. 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
Main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1a, and Phase 1b: The incidence and safety profile of participants with adverse events (AEs), serious adverse events(SAE) | 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 | 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) | Through study completion, an average of 42 Days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1a, and Phase 1b: The immunogenicity of KD6005 | Phase 1a: Through study completion, an average of 42 Days; Phase 1b: Through study completion, an average of 57 Days | Including the incidence of ADA positive. For ADA positive patients, the incidence of neutralizing antibody (NAB) will be analyzed. |
| Phase 1b: The Pharmacokinetics(PK) profile of KD6005: Maximum observed serum concentration (Cmax) | 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) | Through study completion, an average of 57 Days | Preliminary pharmacodynamic evaluation in RA participants. |
| Phase 1b: Change From Baseline in C-reactive protein (CRP) | Through study completion, an average of 57 Days | Preliminary pharmacodynamic evaluation in RA participants. |
| Phase 1b: Change From Baseline in anti-Cyclic citrullinated peptide antibody (anti-CCP) | Through study completion, an average of 57 Days | Preliminary pharmacodynamic evaluation in RA participants. |
| Phase 1b: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response | Through study completion, an average of 57 Days | Preliminary pharmacodynamic evaluation in RA participants. |
| Phase 1b: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50% Improvement (ACR50) Response | Through study completion, an average of 57 Days | Preliminary pharmacodynamic evaluation in RA participants. |
| Phase 1b: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70% Improvement (ACR70) Response | Through study completion, an average of 57 Days | Preliminary pharmacodynamic evaluation in RA participants. |
| Phase 1b: Change From Baseline in Disease Activity Score for 28 Joint Counts (DAS28) Using CRP | Through study completion, an average of 57 Days | Preliminary pharmacodynamic evaluation in RA participants. |
| Phase 1b: Change From Baseline in Disease Activity Score for 28 Joint Counts (DAS28) Using ESR | Through study completion, an average of 57 Days | Preliminary pharmacodynamic evaluation in RA participants. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORYi Fang
Peking University People's Hospital
Outcome results
None listed