NCT03794180

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

Completed Phase 1 Last updated 18 December 2019

What this trial tests

Phase 1 trial testing TJ003234 in Healthy Adult Subjects in 32 participants. Completed in 5 September 2019.

Timeline

18 March 2019

Primary endpoint
5 September 2019

5 September 2019

Quick facts

Lead sponsor	I-Mab Biopharma US Limited
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	32
Start date	18 March 2019
Primary completion	5 September 2019
Estimated completion	5 September 2019
Sites	1 location across United States

Drugs / interventions tested

• TJ003234
• Placebo

Conditions studied

• Healthy Adult Subjects — all drugs for Healthy Adult Subjects →

Sponsor

I-Mab Biopharma US Limited — full company profile →

Who can join

Adults 18 to 70, any sex, with Healthy Adult Subjects. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. GM-CSF in inflammation.
   Hamilton JA. · · 2020 · cited 236× · PMID 31611249 · DOI 10.1084/jem.20190945
2. Tissue macrophages: origin, heterogenity, biological functions, diseases and therapeutic targets.
   Guan F, Wang R, Yi Z, Luo P, et al · · 2025 · cited 155× · PMID 40055311 · DOI 10.1038/s41392-025-02124-y
3. GM-CSF: A Promising Target in Inflammation and Autoimmunity.
   Lee KMC, Achuthan AA, Hamilton JA. · · 2020 · cited 112× · PMID 33150139 · DOI 10.2147/itt.s262566
4. Targeting GM-CSF in COVID-19 Pneumonia: Rationale and Strategies.
   Bonaventura A, Vecchié A, Wang TS, Lee E, et al · · 2020 · cited 112× · PMID 32719685 · DOI 10.3389/fimmu.2020.01625
5. Repurposing of Biologic and Targeted Synthetic Anti-Rheumatic Drugs in COVID-19 and Hyper-Inflammation: A Comprehensive Review of Available and Emerging Evidence at the Peak of the Pandemic.
   Cavalli G, Farina N, Campochiaro C, De Luca G, et al · · 2020 · cited 27× · PMID 33442386 · DOI 10.3389/fphar.2020.598308
6. Targeting rheumatoid arthritis: a molecular perspective on biologic therapies and clinical progress.
   Jain A, Bishnoi M, Prajapati SK, Acharya S, et al · · 2025 · cited 3× · PMID 40707975 · DOI 10.1186/s13036-025-00534-8
7. Recent advances in passive immunotherapies for COVID-19: The Evidence-Based approaches and clinical trials.
   Farhangnia P, Dehrouyeh S, Safdarian AR, Farahani SV, et al · · 2022 · cited 2× · PMID 35483235 · DOI 10.1016/j.intimp.2022.108786
8. Targeting GM-CSF in Rheumatoid Arthritis: Advances in Cytokine-Directed Immunotherapy and Clinical Implications.
   García-Domínguez M. · · 2025 · PMID 41302161 · DOI 10.3390/life15111737