A Study of KD6005 in Healthy Participants and Participants With Rheumatoid Arthritis (RA)

NCT06213259 | Completed Phase 1

• 1 other identifier: KD6005CT01
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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).

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (8)

• 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)

  Through study completion, an average of 42 Days

Secondary Outcomes (15)

• 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

Study Arms (4)

KD6005 (Healthy)

EXPERIMENTAL

Healthy participants will receive a single dose of KD6005 in dose escalation cohorts subcutaneously (SQ).

Drug: KD6005

Placebo (Healthy)

PLACEBO COMPARATOR

Healthy participants will receive a single dose of placebo, SQ.

Drug: Placebo

KD6005(RA)

EXPERIMENTAL

Participants with RA will receive a multiple-dose of KD6005 in dose escalation cohorts, SQ.

Drug: KD6005

Placebo (RA)

PLACEBO COMPARATOR

Participants with RA will receive a multiple-dose of placebo, SQ.

Drug: Placebo

Interventions

Placebo DRUG

Placebo, SQ

Placebo (Healthy); Placebo (RA)

KD6005 DRUG

Biological: KD6005, SQ

KD6005 (Healthy); KD6005(RA)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Shanghai Kanda Biotechnology Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Yi Fang

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: January 19, 2024
• Study Start: January 6, 2024
• Primary Completion: January 10, 2025
• Study Completion: January 10, 2025
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

CN (1)