Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Healthy Adult Subjects

Healthy Adult Subjects Clinical Trial

Official title:

First-in-Human, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of TJ003234 (Anti-Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) Monoclonal Antibody) in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03794180
• Other study ID #: TJ003234RAR101
• Status: Completed
• Phase: Phase 1
• Start date: March 18, 2019
• Est. completion date: September 5, 2019

Study information

• Verified date: December 2019
• Source: I-Mab Biopharma Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

TJ003234RAR101 is a first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled, single ascending dose study of TJ003234 in healthy adults to determine whether TJ003234 is safe and tolerated when administered as an intravenous (IV) infusion and to determine the maximum dose tolerated (MTD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 5, 2019
• Est. primary completion date: September 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Able to understand and willing to sign the informed consent form (ICF)

• Healthy subjects 18-70 years of age

• If of childbearing potential, agree to use protocol-specified contraception

• Body mass index (BMI) 19.0-32.0 kg/m^2

• Blood pressure = 139/89 mm Hg

• Subjects are able to follow the study protocol and complete the trial

Exclusion Criteria:

• Current use of tobacco or nicotine-containing products or illicit drug use

• History of severe allergic or anaphylactic reaction to a therapeutic drug or severe seasonal allergies

• Any known pulmonary disease

• Use of any prescription, investigational drugs, herbal supplements, or nonprescription drugs within 1 month or 5 half-lives (whichever is longer) prior to study drug administration, or dietary supplements within 1 week prior to study drug administration, unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study

• Abnormal hematological and chemistry laboratory values >10% above upper limit of normal (ULN) or >10% below the lower limit of normal (LLN). Absolute neutrophil count (ANC) = 1000 cells/mm^3

• Use of any biologic drugs in the last 120 days prior to dosing.

• Immunization with a live or attenuated vaccine within 4 weeks prior to study drug administration

• Prior treatment with any biologic anti-GM-CSF or GM-CSF receptor antagonists

• ADA screening positive

• Subjects who have a history of documented autoimmune disease, even if not clinically severe or never treated with systemic steroids or immunosuppressive agents

• A positive alcohol test and/or urine drug screen for substance of abuse at screening or upon check-in to the clinical site

Related Conditions & MeSH terms

• Healthy Adult Subjects

Intervention

Drug:
• TJ003234
Brownish-yellow liquid containing TJ003234, a recombinant humanized immunoglobulin (Ig) G1 monoclonal antibody diluted with normal saline
• Placebo
Colorless to slightly brownish-yellow liquid without TJ003234 diluted with normal saline

Locations

Country	Name	City	State
United States	Pharmaron	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
I-Mab Biopharma Co. Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Profile: AEs	Incidence of Adverse Events (AEs)	Up to 85 days after study drug administration
Primary	Maximum Tolerated Dose	Determine Maximum Tolerated Dose of TJ003234	Up to 85 days after study drug administration
Secondary	Pharmacokinetic (PK) Parameters: Tmax	Time of peak concentration (Tmax)	Up to 85 days after study drug administration
Secondary	Pharmacokinetic (PK) Parameters: Cmax	Maximal Concentration (Cmax)	Up to 85 days after study drug administration
Secondary	Pharmacokinetic (PK) Parameters: T1/2	Investigational product (IP) half-life (T1/2)	Up to 85 days after study drug administration
Secondary	Pharmacokinetic (PK) Parameters: CL	Investigational Product (IP) Clearance (CL)	Up to 85 days after study drug administration
Secondary	Pharmacokinetic (PK) Parameters: AUC8	Area under the curve from time zero extrapolated to infinity (AUC8)	Up to 85 days after study drug administration
Secondary	Anti-drug antibodies (ADA)	Incidence and concentration of anti-drug antibodies	Up to 85 days after study drug administration