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).

Official 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).

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: DOUBLE
• Enrollment: 73 participants

Interventions

• DRUG: KD6005 — Biological: KD6005, SQ
• DRUG: Placebo — Placebo, SQ

Primary Outcomes

• 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)
• 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)

Secondary Outcomes

• 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)
• 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)

Trial Locations

• Peking University People's Hospital, Beijing, China

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