← Back to Search

Other

MAD cohort 3 active treatment for Healthy Subjects

Phase 1

Recruiting

Research Sponsored by Inmagene LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up sad cohort from day 1 to day 8, mad cohort from day 1 to day 17, fe cohort from day 1 to day 8

Awards & highlights

Study Summary

This trial tests the safety and how the body processes a new medication in healthy adults.

Who is the study for?

Healthy adults aged 18-60 with a BMI of 18.5 to less than 32 and weighing at least 45 kg can join this trial. They must be able to follow the study procedures, provide consent, and use effective contraception if applicable. Exclusions include history of certain cancers, severe allergies to BTK inhibitors, risk of bleeding, active infections like TB or COVID-19, abnormal lab values (blood counts, liver enzymes), impaired kidney function or significant ECG abnormalities.Check my eligibility

What is being tested?

The trial is testing different doses of IMG-004 in healthy participants to assess safety and how the body processes it. It's a Phase 1 study where some people will get IMG-004 and others will get a placebo without knowing which one they're getting (double-blind). The doses vary from single ascending dose (SAD) trials up to multiple ascending dose (MAD) trials including an open-label part for food effect.See study design

What are the potential side effects?

Since this is a Phase 1 trial primarily focused on safety and tolerability, specific side effects are not listed but may include typical drug-related reactions such as nausea, headaches, dizziness or allergic reactions. Participants will be closely monitored for any adverse effects throughout the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ sad cohort from day 1 to day 8, mad cohort from day 1 to day 17, fe cohort from day 1 to day 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~sad cohort from day 1 to day 8, mad cohort from day 1 to day 17, fe cohort from day 1 to day 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and sad cohort from day 1 to day 8, mad cohort from day 1 to day 17, fe cohort from day 1 to day 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety of IMG-004

Secondary outcome measures

PK parameters of IMG-004

Trial Design

17Treatment groups

Experimental Treatment

Placebo Group

Group I: SAD cohort 5 active treatmentExperimental Treatment1 Intervention

600mg.

Group II: SAD cohort 4 active treatmentExperimental Treatment1 Intervention

400mg.

Group III: SAD cohort 3 active treatmentExperimental Treatment1 Intervention

200mg

Group IV: SAD cohort 2 active treatmentExperimental Treatment1 Intervention

100mg.

Group V: SAD cohort 1 active treatmentExperimental Treatment1 Intervention

30mg

Group VI: MAD cohort 3 active treatmentExperimental Treatment1 Intervention

300mg

Group VII: MAD cohort 2 active treatmentExperimental Treatment1 Intervention

150mg

Group VIII: MAD cohort 1 active treatmentExperimental Treatment1 Intervention

50mg

Group IX: Food Effect cohortExperimental Treatment1 Intervention

150mg

Group X: SAD cohort 1 placeboPlacebo Group1 Intervention

30mg

Group XI: SAD cohort 5 placeboPlacebo Group1 Intervention

600mg.

Group XII: SAD cohort 4 placeboPlacebo Group1 Intervention

400mg.

Group XIII: MAD cohort 1 placeboPlacebo Group1 Intervention

50mg

Group XIV: MAD cohort 2 placeboPlacebo Group1 Intervention

150mg

Group XV: SAD cohort 3 placeboPlacebo Group1 Intervention

200mg.

Group XVI: MAD cohort 3 placeboPlacebo Group1 Intervention

300mg

Group XVII: SAD cohort 2 placeboPlacebo Group1 Intervention

100mg.

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Inmagene LLCLead Sponsor

5 Previous Clinical Trials

178 Total Patients Enrolled

Inmagene BiopharmaceuticalsLead Sponsor

2 Previous Clinical Trials

69 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial currently recruiting participants?

"Clinicaltrials.gov indicates that, since its inception on August 8th 2022 and after numerous revisions, this trial is actively recruiting participants."

Answered by AI

What is the enrollment figure for this clinical trial?

"Affirmative. According to clinicaltrials.gov, this investigation is actively welcoming enrollees and was published on August 8th 2022 after the last update on March 6th 2023. 74 willing participants are needed at one site for successful recruitment."

Answered by AI

What are the associated risks of being part of cohort 4 with SAD?

"Since this is only a Phase 1 trial, there is limited data to evaluate both the efficacy and safety of SAD cohort 4; therefore, it has been assigned a score of 1."

Answered by AI

Does this research program extend to the elderly population?

"To be eligible for this trial, individuals must fall between 18 and 60 years old. There are 51 studies dedicated to younger participants and 366 that focus on older age groups."

Answered by AI

How can I become a participant in this clinical trial?

"This research requires 74 test subjects aged between 18 and 60 that are in good health. Male participants must agree to practice true abstinence; be surgically sterilized (performed at least 6 months prior and documented to no longer produce sperm - verbal confirmation through medical history review acceptable); or agree to use a condom plus ensure use of effective contraception by their female partner of childbearing potential (ie, established use of hormonal contraception - started at least 30 days before Day 1; or placement or an intrauterine device or intrauterine system, diaphragm with spermicide or cervical sponge with spermicide) from screening and for at least 30"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate IMG-004 in Healthy Participants

2022. "Study to Evaluate IMG-004 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05349097.