RE104 for Lactation

Phase 1

Recruiting

Research Sponsored by Reunion Neuroscience Inc

Eligibility Criteria Checklist

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

Must have

* Females between 18 and 45 years of age, at elast 50 kgs, and a body mass index of 18-34 kg/m2

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from dosing through study completion (post-dose follow-up is for 14 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to gather information on how a medication called RE104 is removed from breastmilk of healthy breastfeeding volunteers. This data will help determine when it is safe for mothers to resume breastfeeding after taking

Who is the study for?

Healthy breastfeeding women, aged 18-45, who've been nursing or pumping for at least 4 weeks postpartum. Participants must weigh at least 50 kg with a BMI of 18-34 kg/m2, not be pregnant nor planning to become so during the study. They must stop breastfeeding for two weeks and confirm their infant can bottle-feed.

What is being tested?

The trial is studying RE104 for Injection in lactating mothers to see how long it takes for the drug and its byproducts to clear from breastmilk. This will help determine when it's safe to resume breastfeeding after receiving this single-dose injection.

What are the potential side effects?

Specific side effects are not listed here, but generally may include reactions at the injection site, changes in milk production or composition, and any other systemic symptoms as a result of exposure to RE104.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman aged 18-45, weigh at least 50 kg, and my BMI is between 18-34.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from dosing through study completion (post-dose follow-up is for 14 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from dosing through study completion (post-dose follow-up is for 14 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from dosing through study completion (post-dose follow-up is for 14 days) for reporting.