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NCT05349097 · ClinicalTrials.gov registry record · Phase 1

Study to Evaluate IMG-004 in Healthy Participants

A Phase 1 study, sponsored by Inmagene.

Completed
Registry status
Phase 1
Development phase
72
Enrollment target

NCT05349097: Completed Phase 1 study, sponsored by Inmagene.

NCT05349097 is a Phase 1 study that has completed, run by Inmagene. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05349097, a Phase 1 study, has completed, sponsored by Inmagene.

COMPLETED
Registry status
Phase 1
Development phase
72 participants
Enrollment target

Study Summary

A Phase 1, Randomized, Double-blind, Placebo-controlled Study of Orally Administered IMG-004 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Dose(s) and an Open-Label Study of Single Oral Dose of IMG-004 to Evaluate the Food Effect in Healthy Participants

Primary Outcome

Incidence and severity of AEs, including clinically relevant findings from vital signs, physical examination, laboratory tests, and 12-lead ECG

Interventions

  • DRUG SAD IMG-004 30mg
  • DRUG SAD IMG-004 100mg
  • DRUG SAD IMG-004 200mg
  • DRUG SAD IMG-004 400mg
  • DRUG SAD IMG-004 600mg

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2022-08-08
Est. Completion 2024-05-02
Phase Phase 1
Inmagene

5 total trials

What the finished NCT05349097 record still lists

NCT05349097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).

The record links to 0 conditions, and to 5 interventions - of which SAD IMG-004 30mg is the first listed.

NCT05349097 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05349097 about?

NCT05349097 is a clinical study titled "Study to Evaluate IMG-004 in Healthy Participants". A Phase 1, Randomized, Double-blind, Placebo-controlled Study of Orally Administered IMG-004 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Dose(s) and an Open-Label Study of Single Oral Dose of IMG-004 to Evaluate the Food Effect in Healthy Participants

What is the current status of trial NCT05349097?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2022-08-08. Estimated completion is 2024-05-02.

What interventions are being tested in trial NCT05349097?

The interventions under investigation include: SAD IMG-004 30mg (DRUG), SAD IMG-004 100mg (DRUG), SAD IMG-004 200mg (DRUG), SAD IMG-004 400mg (DRUG), SAD IMG-004 600mg (DRUG).

Who is sponsoring clinical trial NCT05349097?

This trial is sponsored by Inmagene, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05349097's enrollment target sits among peer trials

72 736th of 2000 higher than 1,254 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 NCT05349097, the US trial registry maintained by the National Library of Medicine. NCT05349097 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.