RE104 for Healthy Volunteers

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

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Reunion Neuroscience Inc

Disqualifiers: Bipolar, Schizophrenia, Psychotic, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the body absorbs, breaks down, and eliminates a new drug, RE104, in healthy volunteers. Researchers will track the drug and its breakdown products in blood, urine, and feces for about a week after a single injection. The trial seeks healthy individuals willing to try a drug with mind-altering effects. Interested participants should have no personal or family history of certain mental health disorders. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the unique opportunity to be among the first to receive this new drug.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop your current medications, but it mentions that you should not use prohibited medications. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that RE104 has been tested for safety in healthy adults. Studies found that a single dose of up to 30 mg, administered just under the skin, is generally safe and well-tolerated. Participants did not report any serious side effects. Comparisons with current treatments for postpartum depression suggest that RE104 might be safer or cause fewer side effects. While these findings are promising, they come from early trials. More research is needed to fully understand the safety of RE104. ^{1 2 3 4 5}

Why are researchers excited about this study treatment?

Researchers are excited about 2-[14C]-RE104 because it offers a unique approach compared to current treatments. Unlike traditional options, this drug uses a radiolabeled compound, which allows scientists to track how the body processes it. This innovative feature could provide deeper insights into the drug's absorption, distribution, and elimination, potentially leading to more effective dosing and improved safety profiles. Additionally, the subcutaneous injection method is designed to ensure precise delivery, which could enhance its effectiveness and reduce side effects.

What evidence suggests that RE104 is effective for healthy volunteers?

Research has shown that RE104 is a promising new treatment under study for its quick and long-lasting psychedelic effects. In this trial, healthy volunteers will receive a single 30 mg dose of 2-[14C]-RE104, administered just under the skin, which previous studies generally found to be well-tolerated. Early results suggest that RE104 might help treat depression by affecting serotonin, a brain chemical that regulates mood. The compound resembles 4-HO-DiPT, known for its short-lasting psychedelic effects, and may help manage depression symptoms. However, more evidence is needed to confirm its effectiveness for specific conditions like postpartum depression. ^{2 3 6 7 8}

Who Is on the Research Team?

Mark Pollack, Chief Medical Officer

Principal Investigator

Reunion Neuroscience Inc

Are You a Good Fit for This Trial?

Healthy volunteers aged 18-45, weighing at least 50 kg with a BMI of 18-34 kg/m2. Participants must be willing to take a drug that affects the mind and use birth control if they can have children. Men must use condoms with spermicide for up to 90 days post-study. No participation in other trials is allowed during this study.

Inclusion Criteria

I agree not to donate sperm or eggs for 120 days after treatment ends.

I can follow the study plan and agree to sign the consent form.

I agree not to join other studies with experimental drugs or devices while in this 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 2-[14C]-RE104

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with samples collected for 168 hours post-dosing

1 week

Multiple visits (in-person) for sample collection

What Are the Treatments Tested in This Trial?

Interventions

• 2-[14C]-RE104

Trial Overview The trial studies how the body absorbs, breaks down, and gets rid of RE104 and its by-products after being injected under the skin. It involves tracking these substances in blood, urine, and feces for over a week following dosing.

How Is the Trial Designed?

Group I: 30 mg 2-[14C]-RE104 (1uCi/30mg) Experimental Treatment 1 Intervention

A single subcutaneous injection of 30 mg 2-\[14C\]-RE104 for Injection

Who Is Running the Clinical Trial?

Reunion Neuroscience Inc

Lead Sponsor

Trials

2

Recruited

90+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12379775/

Safety, Tolerability, Pharmacokinetics, and ... - PubMed Central This study in healthy adult volunteers showed that a single SC dose of RE104 at 30 mg was generally well-tolerated with robust pharmacodynamic ( ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06342310

RE104 Safety and Efficacy Study in Postpartum Depression The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms in participants with moderate-to- ...

3. withpower.com withpower.com/trial/phase-1-healthy-participant-study-7-2025-e9aa8

RE104 for Healthy Volunteers The purpose of this study is to characterize the absorption, metabolism and routes of excretion of RE104 and its metabolites in healthy volunteers .

4. reunionneuro.com reunionneuro.com/wp-content/uploads/2023/07/Reunion-Neuroscience-Inc.-Completes-Interim-Data-Analysis-for-Phase-1-Clinical-Trial-with-Novel-Serotonergic-Psychedelic-RE104.pdf

First-in-Human Findings Highlight RE104's ... RE104 is a proprietary, novel serotonergic psychedelic compound that Reunion is developing as a potential fast-acting and durable treatment for ...

5. pubs.acs.org pubs.acs.org/doi/10.1021/acschemneuro.4c00058

RE104: Synthesis and Activity of a Novel Serotonergic ... The glutarate ester can act as an efficient prodrug strategy for 4-HO-DiPT, a unique short-duration psychedelic with potential in depressive disorders.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07146191?term=NA

RE104 Radiolabeled Mass Balance (hAME) Study The purpose of this study is to characterize the absorption, metabolism and routes of excretion of RE104 and its metabolites in healthy volunteers . This study ...

7. psychiatrictimes.com psychiatrictimes.com/view/re104-a-novel-fast-acting-psychedelic-for-postpartum-depression

RE104: A Novel, Fast-Acting Psychedelic for Postpartum ... Data from the phase 1 study in healthy adults show a favorable safety profile compared with available PPD treatments. When phase 2 is completed ...

8. reunionneuro.com reunionneuro.com/2025/08/18/reunion-neuroscience-announces-positive-topline-results-from-reconnect-phase-2-clinical-trial-of-re104-for-the-treatment-of-postpartum-depression-ppd/

Achieved Primary Endpoint with 30mg Dose of RE104 ... In RECONNECT, RE104 was observed to be generally well-tolerated, consistent with previously reported Phase 1 safety data with RE104 and other ...