Phase 1 Depression and Anxiety Trial, Not Yet Recruiting NCT07334249 Sponsor: Synphatec (Shanghai) Biopharmaceutical Technology Co., Ltd. Condition: Depression and Anxiety
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Phase 1 Depression and Anxiety Trial, Not Yet Recruiting

NCT07334249
Not Yet Recruiting Phase 1

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • People who are willing and able to give written consent to participate.
  • Adults aged 18 to 45 years old (inclusive), who are healthy males or females, with an equal number of males and females enrolled.
  • People who are willing to use effective contraception as required by the study and who have no plans for pregnancy, sperm donation, or egg donation until at least 3 months after the last dose.
  • People whose body weight is at least 50 kg (males) or at least 45 kg (females), and whose Body Mass Index (BMI) is between 18 and 28 kg/m².
  • People with normal results from blood tests, a physical examination, medical and surgical history review, and a heart tracing (ECG), with no signs of active or ongoing disease.
  • People who are willing and able to follow all study procedures, restrictions, and visit schedules, and who can communicate clearly with the study team.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People with special dietary needs who cannot follow a standard shared meal plan — for example, those who cannot tolerate certain foods or who have difficulty swallowing.
  • People who have had a bad reaction to a drip (IV infusion) in the past, have difficult or unsuitable veins for a drip, have difficulty with blood draws, or have a history of fainting or extreme fear related to needles or blood.
  • People who are breastfeeding, or who have a positive pregnancy test at the time of screening or at the start of the study.
  • People who have had a fever or an active infection in the 14 days before the first dose.
  • People with a history of drug or substance misuse in the past 5 years, those who regularly use any drugs or substances, or those who test positive for drugs in a urine test at screening or at the start of the study.
  • People with reduced kidney function, as measured by an eGFR below 90 mL/min/1.73 m² (confirm with trial site for full details).
  • People with a history of a heart rhythm problem called QTc prolongation, or who show a clinically significant abnormality on their heart tracing (ECG) at screening.
  • People who have smoked more than 5 cigarettes a day on average in the 3 months before screening, who are unable to stop using tobacco products during the trial, or who test positive for nicotine.
  • People who have taken part in this study before, who have received an experimental treatment within the 30 days before the study starts, or who plan to join another clinical trial during this study.
  • People who test positive at screening for hepatitis B, hepatitis C, HIV, or syphilis.
  • People who have any abnormal screening results that the study doctor considers clinically significant — for example, a resting heart rate below 55 or above 100 beats per minute, blood pressure outside the acceptable range, or clinically relevant ECG or blood test abnormalities.
  • People who have lost a significant amount of blood (200 mL or more) in the 60 days before dosing — including from injury, blood tests, or donation — or who plan to donate blood during the study or within 30 days after their dose.
  • People with a history of alcohol misuse, those who have drunk more than 14 units of alcohol per week on average in the 3 months before screening, those who test positive for alcohol at the start of the study, or those who are unable to avoid alcohol for the full duration of the study.
  • People who regularly consume large amounts of tea, coffee, or other caffeine-containing drinks over a prolonged period in the 3 months before screening, or who have had caffeine-containing or grapefruit-containing foods or drinks within 24 hours before the first infusion.
  • People who have used prescription medicines, over-the-counter medicines (except for hormonal contraceptives or certain topical products with no systemic effect), herbal medicines, or supplements such as vitamins or calcium in the 14 days before screening or during the screening period, unless the study doctor and sponsor have given prior approval.
  • People who have used medicines that affect the liver's ability to break down drugs in the 30 days before screening.
  • People who have had a major surgical procedure in the 6 months before screening, or who have planned surgery during the study.
  • People with a current or past history of psychiatric or neurological conditions, or any problems affecting their movement or senses, whether confirmed or suspected.
  • People with any clinically significant illness, condition, or finding that, in the study doctor's opinion, could put the person at risk or interfere with the study.
  • People with a history of or current hallucinations, which the study doctor considers unsuitable for participation.
  • People with a history of or current psychiatric disorders and/or brain dysfunction.
  • People with a known or suspected allergy or sensitivity to any ingredient in the study drug, or to related medicines or foods.
  • People who, for any other reason, are considered unsuitable for the study by the study doctor.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 31 July 2026

Contact this trial

Phone: +8613911873347

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Phase 1
Sponsor
Synphatec (Shanghai) Biopharmaceutical Technology Co., Ltd.
Registry
ClinicalTrials.gov
Start date
23 December 2025
Est. completion
30 June 2026

This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Treatment Emergent Adverse Events, throughout study completion

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov