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NCT03794180 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by I-Mab Biopharma US Limited.

Completed
Registry status
Phase 1
Development phase
32
Enrollment target

NCT03794180: Completed Phase 1 study, sponsored by I-Mab Biopharma US Limited.

NCT03794180 is a Phase 1 study that has completed, run by I-Mab Biopharma US Limited. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03794180, a Phase 1 study, has completed, sponsored by I-Mab Biopharma US Limited.

COMPLETED
Registry status
Phase 1
Development phase
32 participants
Enrollment target

Study 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).

Primary Outcome

Incidence of Adverse Events (AEs)

Interventions

  • DRUG Placebo
  • DRUG TJ003234

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2019-03-18
Est. Completion 2019-09-05
Phase Phase 1
I-Mab Biopharma US Limited

7 total trials

What the finished NCT03794180 record still lists

NCT03794180 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03794180 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03794180 about?

NCT03794180 is a clinical study titled "Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Healthy Adult Subjects". 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 tol...

What is the current status of trial NCT03794180?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2019-03-18. Estimated completion is 2019-09-05.

What interventions are being tested in trial NCT03794180?

The interventions under investigation include: Placebo (DRUG), TJ003234 (DRUG).

Who is sponsoring clinical trial NCT03794180?

This trial is sponsored by I-Mab Biopharma US Limited, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03794180's enrollment target sits among peer trials

32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03794180, the US trial registry maintained by the National Library of Medicine. NCT03794180 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.