Study of Felzartamab in Healthy Adult Subjects

NCT06285201 | Completed Phase 1

• 1 other identifier: TJ202001BE104
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 1 Clinical Study to Evaluate the Pharmacokinetic Comparability, Safety, Tolerability, and Immunogenicity of Felzartamab for Injection Pre- and Post-changes of Process in Healthy Male Adult Subjects in China (Randomized, Double-blind, Single-dose, Two-formulation, Two-sequence, Two-period Crossover Design)

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Primary PK Endpoint

  AUC0-∞

  36 days after dosing

Study Arms (2)

Group A

EXPERIMENTAL

T-R

Drug: T; Drug: R

Group B

EXPERIMENTAL

R-T

Drug: T; Drug: R

Interventions

T DRUG

8 mg/kg IV of Test drug manufactured by I-Mab Biopharma(Hangzhou)

Group A; Group B

R DRUG

8 mg/kg IV of Test drug manufactured by Patheon Italia

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male subjects aged ≥ 18 years and ≤ 50 years when signing the ICF.
• Weight ≥ 50 kg and ≤ 80 kg, with a BMI ≥ 19.0 and ≤ 28.0 kg/m2 (inclusive).
• The study doctor determines that the overall health status of the subject is good (normal or abnormal but not clinically significant) based on the subject's medical history, physical examinations, vital signs, ECG, and laboratory test results.
• Subjects who are voluntarily participate in the study, and can understand and sign the ICF.
• Subjects (including their partners) who have no plans for pregnancy or sperm donation during the study and within 6 months after the last dose, and voluntarily use effective contraceptive measures. Specific contraceptive measures are described in Appendix 4.

You may not qualify if:

• Subjects with diseases that may affect his safety or the results of the study, including but not limited to cardiovascular, respiratory, endocrine, metabolic, renal, hepatic, gastrointestinal, dermatological, infectious, malignant tumors, hematological, skeletal, genitourinary, neurological/psychiatric diseases, and are clinically significant in the opinion of the investigator.
• Subjects who have had acute, chronic, or potential infectious diseases within 1 month pre-dose.
• Subjects with known immune system diseases (such as autoimmune diseases or immunodeficiency diseases), including but not limited to autoimmune hemolytic anemia, etc.
• Subjects who have had a single episode of herpes zoster (shingles) involving the skin or central nervous system within the 6 months pre-dose.
• Subjects who currently have or have a history of multiple episodes of herpes zoster involving the skin or central nervous system.
• Subjects with chronic diarrhea or enteritis within 1 year pre-dose.
• Subjects with positive result for blood group antibody screening (IAT).
• Subjects who have received monoclonal antibodies, cell therapies within 6 months pre-dose, or have previously received daratumumab or similar drugs, or drugs targeting CD38.
• Subjects who have taken any medicine, including prescription drugs, over-the-counter drugs, and herbal medicine, within two weeks pre-dose.
• Subjects who are suspected or confirmed to be allergic to multiple drugs or foods, including drugs or drug excipients in this clinical study.
• Subjects who have a history of fear of needles or blood, or have difficulty with venous blood collection (have a history of difficulty with blood collection or have corresponding symptoms and signs, and cannot tolerate venous puncture).
• Subjects with the history of blood donation or blood loss of ≥ 200mL in total within 3 months pre-dose;
• Subjects who have participated in any other clinical studies of investigation drug or medical device within the 3 months pre-dose (or 5 half-lives for investigation drugs with so long half-life that the duration of its 5 half- lives is \> 3 months).
• Subjects who have undergone major surgery within the last 3 months prior to signing the ICF.
• Subjects who are positive for Hepatitis B (positive for HBsAg or HBcAb and HBV-DNA levels of ≥ 500 cps/mL \[or HBV-DNA ≥ 100 IU/mL\]), HCV antibodies, HIV antibodies, and anti-TP antibodies.

Sponsors & Collaborators

• TJ Biopharma Co., Ltd.: lead

Study Sites (1)

The First Hospital of Jilin University

Jilin, Changchun, China

Location

Study Officials

• Xiaojiao Li, Doctor

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: March 27, 2024
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)