Phase 1 Phenylketonuria Trial, Recruiting NCT07685210 Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. Condition: Phenylketonuria
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Phase 1 Phenylketonuria Trial, Recruiting

NCT07685210
Recruiting Phase 1

Who may 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 might be able to join this trial:

  • Men and women between 18 and 45 years old, with at least 3 participants of each gender included in the study groups.
  • People with a body mass index (a measure of body weight relative to height) between 19 and 26, where men weigh at least 50 kg and women weigh at least 45 kg.
  • People who are willing to sign a consent form after being fully informed about the risks and procedures involved in the research.
  • People who are willing to use reliable contraception for 3 months after the last dose, and who have no plans to become pregnant or donate sperm or eggs during that time.

Who may not be able to join:

  • People with a family history of sudden death or serious mental or neurological conditions.
  • People with significant ongoing health conditions, such as problems absorbing nutrients from food, or chronic liver, kidney, heart, or hormonal disorders.
  • People with abnormal liver or kidney function, a kidney filtration rate below a certain level, an abnormal heart rhythm measurement on an ECG, or who test positive for certain infectious diseases.
  • People with known drug allergies, a history of drug misuse, or who have recently taken part in another clinical trial.
  • People who drink alcohol, smoke, consume grapefruit or amino acid supplements, or have an irregular daily routine during the screening period.
  • Women who are pregnant or breastfeeding, or people who are unable to tolerate blood draws or who faint at the sight of needles.

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 28 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +86 15131190710

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
Recruiting
Phase
Phase 1
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
22 June 2026
Est. completion
1 September 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Adverse events and clinical safety indicators after a single dose.; Change in QT/QTc interval correction ΔΔQTc after dosing.

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: 28 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