RE104 for Lactation

Overseen By Mark Pollack, Chief Medical Officer, M.D.

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: Reunion Neuroscience Inc

Must not be taking: Prohibited medications

Disqualifiers: Mastitis, Bipolar, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Single dose

14 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to obtain data necessary to characterize the elimination of RE104 and metabolites from breastmilk of health lactating volunteers to support a regulatory assessment of when mothers can safely return to breastfeeding following a single-dose of RE104 for Injection.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications, but it mentions that the use of prohibited medications is not allowed. It's best to discuss your specific medications with the trial team.

How is the drug RE104 for Injection unique compared to other treatments for lactation?

The drug RE104 for Injection, also known as 4-OH-DiPT, is unique because it is being studied specifically for lactation, a condition with no standard treatments. This makes it a novel approach compared to existing options. ^{1 2 3 4 5}

Who Is on the Research Team?

Mark Pollack, Chief Medical Officer

Principal Investigator

Reunion Neurosciences Inc

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I have been breastfeeding or pumping for at least 4 weeks after having a full-term pregnancy.

I agree to stop breastfeeding and confirm my baby can bottle-feed during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single subcutaneous injection of 30 mg RE104

Single dose

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 days

What Are the Treatments Tested in This Trial?

Interventions

• RE104 for Injection

Trial Overview 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.

How Is the Trial Designed?

Group I: 30 mg RE104 Experimental Treatment 1 Intervention

A single subcutaneous injection of 30 mg RE104 for Injection

Who Is Running the Clinical Trial?

Reunion Neuroscience Inc

Lead Sponsor

Trials

2

Recruited

90+

Published Research Related to This Trial

Injectable microspheres containing a neurotensin analogue (NA) were successfully created using a novel oil-in-water solvent evaporation method, which effectively entrapped the hydrophilic drug NA.

Optimal conditions for successful entrapment included using an alkaline water phase, adding fatty acid salt to the oily phase, and incorporating a water-miscible solvent, achieving complete entrapment at specific polymer-to-drug ratios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparation of neurotensin analogue-containing poly(dl-lactic acid) microspheres formed by oil-in-water solvent evaporation. Yamakawa, I., Tsushima, Y., Machida, R., et al.[2019]

A pharmacokinetic model for the depot formulation depo-subQ provera 104™ was developed and validated using data from three clinical trials, demonstrating its ability to predict key drug absorption parameters like Cmax and Tmax.

The study highlighted that the drug release profile is influenced by factors such as the injection site and patient population, emphasizing the importance of these variables in optimizing therapeutic efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A sensitive in vitro performance assay reveals the in vivo drug release mechanisms of long-acting medroxyprogesterone acetate microparticles. Gao, GF., Thurn, M., Wendt, B., et al.[2021]

The long-acting injectable microcapsule system for progesterone (P4) provides a controlled release of 1.3 micrograms of P4 per day for up to 30 days, demonstrating a potential for monthly contraceptive use.

In both rats and baboons, a single injection of the P4 microcapsules effectively inhibited vaginal estrous cycles and cyclic ovarian function for one month, indicating its efficacy in reproductive control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new long-acting injectable microcapsule system for the administration of progesterone. Beck, LR., Cowsar, DR., Lewis, DH., et al.[2019]

Retinyl acetate (RA) was successfully encapsulated in PLGA microspheres using supercritical emulsion extraction (SEE), resulting in spherical and free-flowing microspheres with high encapsulation efficiency of 80%-90%.

The continuous operation layout (SEE-C) allowed for better recovery and efficiency, producing microspheres with a mean size of 3.3 to 4.5 μm, and demonstrated a rapid drug release profile, with almost all RA released within 6 days at lower concentrations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PLGA microdevices for retinoids sustained release produced by supercritical emulsion extraction: continuous versus batch operation layouts. Porta, GD., Campardelli, R., Falco, N., et al.[2020]

The study demonstrated that octreotide acetate, delivered via biodegradable PLGA microspheres, exhibits a two-phase drug release profile, with an initial peak in serum levels occurring within 30 minutes, followed by a sustained release phase lasting up to 42 days.

Pharmacokinetic simulations suggest that the Oakwood formulations could maintain steady-state serum levels of octreotide comparable to the established Sandostatin LAR(®) formulation, indicating potential for effective long-term treatment with less frequent dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained-release delivery of octreotide from biodegradable polymeric microspheres. Rhee, YS., Sohn, M., Woo, BH., et al.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Preparation of neurotensin analogue-containing poly(dl-lactic acid) microspheres formed by oil-in-water solvent evaporation. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

A sensitive in vitro performance assay reveals the in vivo drug release mechanisms of long-acting medroxyprogesterone acetate microparticles. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A new long-acting injectable microcapsule system for the administration of progesterone. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

PLGA microdevices for retinoids sustained release produced by supercritical emulsion extraction: continuous versus batch operation layouts. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Sustained-release delivery of octreotide from biodegradable polymeric microspheres. [2021]