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Safety and Pharmacokinetics of Subcutaneous Dose of IMG-007 in Healthy Participants

NCT06304740 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-12-12

No results posted yet for this study

Summary

This is a double-blind, randomized, placebo-controlled study to assess the safety and PK profile of a single subcutaneous dose of IMG-007 in healthy participants. The study will comprise of a 5-week screening period, a 3-day In-patient Period in a clinical research unit (CRU) and an Out-patient Follow-up Period up to 127 days. The study will include 3 dose cohorts which will be enrolled sequentially. Participants will receive a single subcutaneous dose of IMG-007 or placebo at Baseline according to their assigned dose.

Conditions

  • Healthy Volunteers

Interventions

DRUG

IMG-007

Subcutaneous injection of IMG-007

DRUG

Placebo

Subcutaneous Injection of Placebo

Sponsors & Collaborators

  • Inmagene LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-06
Primary Completion
2024-08-28
Completion
2024-08-28

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06304740 on ClinicalTrials.gov