LactationPhase 1NCT06659263
RE104 Clinical Lactation Study
A Phase 1 study testing RE104 for Injection in people with Lactation, run by Reunion Neuroscience Inc at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation
- What is being tested?
- RE104 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2024to 4 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females between 18 and 45 years of age, at least 50 kgs, and a body mass index of 18-34 kg/m2
- Has been breastfeeding or actively pumping for at least 4 weeks postpartum
- Agrees to cease breastfeeding for duration of study (Day 14) and confirms infant is able to feed from a bottle at screening.
- Willing and able to pump in order to maintain sufficient milk supply volumes for the study
- Is not pregnant or planning to become pregnant during the study
- Able to understand and adhere to study schedule and requirements and willing to sign an ICF
- In good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening
Who cannot join
- Has mastitis or other condition that would prevent the collection of milk from one or both breasts
- Active or medical history of significant mental disorder (including but not necessarily limited to major depression and anxiety disorders, bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder), or first-degree family history of psychosis or bipolar disorder
- Medically significant condition or other concomitant condition or history rendering unsuitability for the study, in the judgement of the investigator
- Has used or intends to use of prohibited medications
- Has a known sensitivity or intolerance to hallucinogenic or psychedelic substances, or potential rescue medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Single Dose Study to Evaluate the Concentration of RE104 and Its Major Metabolites in Breast Milk and Plasma of Healthy Lactating Women.
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.
- Conditions
- Lactation
- Being tested
- RE104 for Injection
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RE104 for InjectionDrug
Single, subcutaneous dose of RE104 for Injection
| Study group | Role | What they receive |
|---|---|---|
| 30 mg RE104 | Experimental | A single subcutaneous injection of 30 mg RE104 for Injection Receives: Drug: RE104 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve from time zero to 24 hours post-dose (AUC0 24) for RE104 and 4-OH-DiPT in plasma and breast milk
Measured: Through 24 hours postdose
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for RE104 and 4-OH-DiPT in plasma and breast milk
Measured: Through 168 hours postdose
Maximum observed concentration (Cmax) for RE104 and 4-OH-DiPT in plasma and breast milk
Measured: Through 168 hours postdose
Time to reach Cmax (tmax) for RE104 and 4-OH-DiPT in plasma and breast milk
Measured: Through 168 hours postdose
Apparent total body clearance (CL/F) for RE104 in plasma
Measured: Through 168 hours postdose
Apparent volume of distribution during the terminal phase (Vz/F) for RE104 in plasma
Measured: Through 168 hours postdose
Apparent terminal elimination half-life (t1/2) for RE104 and 4-OH-DiPT in plasma
Measured: Through 168 hours postdose
Milk to plasma (M/P) ratio for RE104 and 4-OH-DiPT in breast milk
Measured: Through 168 hours postdose
Relative infant dose (RID) of RE104 and its active entity 4-OH-DiPT
Measured: Through 72 hours postdose
Total RID of RE104 and its active entity 4-OH-DiPT
Measured: Through 168 hours postdose
Secondary outcomes (9)
Incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.
A treatment-emergent adverse event (TEAE) is defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a study drug.
Measured: From dosing through study completion (post-dose follow-up is for 14 days)
Area under the concentration-time curve from time zero to 24 hours post-dose (AUC0 24) for detectable/quantifiable RE104 metabolites in plasma and breast milk
Measured: Through 24 hours postdose
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for detectable/quantifiable RE104 metabolites in plasma and breast milk
Measured: Through 168 hours postdose
Maximum observed concentration (Cmax) for detectable/quantifiable RE104 metabolites in plasma and breast milk
Measured: Through 168 hours postdose
Time to reach Cmax (tmax) for detectable/quantifiable RE104 metabolites in plasma and breast milk
Measured: Through 168 hours postdose
Apparent terminal elimination half-life (t1/2) for detectable/quantifiable RE104 metabolites in plasma
Measured: Through 168 hours postdose
Milk to plasma (M/P) ratio for detectable/quantifiable RE104 metabolites in breast milk
Measured: Through 168 hours postdose
Amount of RE104 and its active entity 4 OH-DiPT excreted into breast milk (Ae) and amount of drug excreted into breast milk relative to dose (Fe)
Measured: Through 168 hours postdose
Unbound and bound plasma concentrations of the RE104 active entity 4-OH-DiPT.
Measured: 1, 3 and 8 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start13 Nov 2024
- Primary completion28 May 2025
- Study completion4 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LactationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reunion Neuroscience Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Pollack, Chief Medical Officer, Study director, Reunion Neurosciences Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659263
- Sponsor's protocol ID
- RE104-102-NHLV
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single Dose Study to Evaluate the Concentration of RE104 and Its Major Metabolites in Breast Milk and Plasma of Healthy Lactating Women.
- ClinicalTrials.gov ID
- NCT06659263
- Acronym / sponsor ID
- RE104-102-NHLV
- Conditions
- Lactation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Reunion Neuroscience IncIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 30 mg RE104 | Experimental | Drug: RE104 for InjectionA single subcutaneous injection of 30 mg RE104 for Injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Females between 18 and 45 years of age, at least 50 kgs, and a body mass index of 18-34 kg/m2
- Has been breastfeeding or actively pumping for at least 4 weeks postpartum
- Agrees to cease breastfeeding for duration of study (Day 14) and confirms infant is able to feed from a bottle at screening.
- Willing and able to pump in order to maintain sufficient milk supply volumes for the study
- Is not pregnant or planning to become pregnant during the study
Key exclusion criteria (5 listed)
- Has mastitis or other condition that would prevent the collection of milk from one or both breasts
- Active or medical history of significant mental disorder (including but not necessarily limited to major depression and anxiety disorders, bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder), or first-degree family history of psychosis or bipolar disorder
- Medically significant condition or other concomitant condition or history rendering unsuitability for the study, in the judgement of the investigator
- Has used or intends to use of prohibited medications
- Has a known sensitivity or intolerance to hallucinogenic or psychedelic substances, or potential rescue medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RE104 for InjectionSingle, subcutaneous dose of RE104 for Injection | Drug | 30 mg RE104 |
Primary outcome
Area under the concentration-time curve from time zero to 24 hours post-dose (AUC0 24) for RE104 and 4-OH-DiPT in plasma and breast milk
Time frame: Through 24 hours postdose
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for RE104 and 4-OH-DiPT in plasma and breast milk
Time frame: Through 168 hours postdose
Maximum observed concentration (Cmax) for RE104 and 4-OH-DiPT in plasma and breast milk
Time frame: Through 168 hours postdose
Time to reach Cmax (tmax) for RE104 and 4-OH-DiPT in plasma and breast milk
Time frame: Through 168 hours postdose
Apparent total body clearance (CL/F) for RE104 in plasma
Time frame: Through 168 hours postdose
Apparent volume of distribution during the terminal phase (Vz/F) for RE104 in plasma
Time frame: Through 168 hours postdose
Apparent terminal elimination half-life (t1/2) for RE104 and 4-OH-DiPT in plasma
Time frame: Through 168 hours postdose
Milk to plasma (M/P) ratio for RE104 and 4-OH-DiPT in breast milk
Time frame: Through 168 hours postdose
Relative infant dose (RID) of RE104 and its active entity 4-OH-DiPT
Time frame: Through 72 hours postdose
Total RID of RE104 and its active entity 4-OH-DiPT
Time frame: Through 168 hours postdose
9 secondary outcomes
Incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.
Time frame: From dosing through study completion (post-dose follow-up is for 14 days)
Area under the concentration-time curve from time zero to 24 hours post-dose (AUC0 24) for detectable/quantifiable RE104 metabolites in plasma and breast milk
Time frame: Through 24 hours postdose
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for detectable/quantifiable RE104 metabolites in plasma and breast milk
Time frame: Through 168 hours postdose
Maximum observed concentration (Cmax) for detectable/quantifiable RE104 metabolites in plasma and breast milk
Time frame: Through 168 hours postdose
Time to reach Cmax (tmax) for detectable/quantifiable RE104 metabolites in plasma and breast milk
Time frame: Through 168 hours postdose
Apparent terminal elimination half-life (t1/2) for detectable/quantifiable RE104 metabolites in plasma
Time frame: Through 168 hours postdose
Milk to plasma (M/P) ratio for detectable/quantifiable RE104 metabolites in breast milk
Time frame: Through 168 hours postdose
Amount of RE104 and its active entity 4 OH-DiPT excreted into breast milk (Ae) and amount of drug excreted into breast milk relative to dose (Fe)
Time frame: Through 168 hours postdose
Unbound and bound plasma concentrations of the RE104 active entity 4-OH-DiPT.
Time frame: 1, 3 and 8 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No. Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Pollack, Chief Medical Officer study director
Reunion Neurosciences Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RE104 for Injection in people with Lactation, run by Reunion Neuroscience Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve from time zero to 24 hours post-dose (AUC0 24) for RE104 and 4-OH-DiPT in plasma and breast milk (time frame: Through 24 hours postdose). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.