A Phase 1 interventional study of This group of participants take ZL-65 tablet and This group of participants take ZL-65 placebo tablet in Healthy Participants Study, sponsored by Chengdu Zenitar Biomedical Technology Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Chengdu Zenitar Biomedical Technology Co., Ltd · Phase 1, Interventional, and Treatment
To evaluate the tolerability and safety of a single oral dose of ZL-65 tablets in healthy adult trial participants through dose escalation; and to preliminarily assess the pharmacokinetic and pharmacodynamic characteristics of a single oral dose of ZL-65 tablets.Exploring the impact of food intake on the PK of orally administered ZL-65 tablets in healthy adult trial participants.
Chengdu Zenitar Biomedical Technology Co., Ltd is the lead sponsor of 23 studies on the registry; 12 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ZL65
Drug: This group of participants take ZL-65 tablet
Drug: This group of participants take ZL-65 placebo tablet
ZL65 Tablet 5mg ZL65 Tablet 10mg ZL65 Tablet 25mg ZL65 Tablet 50mg ZL65 Tablet 75mg ZL65 Tablet 100mg ZL65 Tablet 125mg
ZL65 Placebo Tablet 5mg ZL65 Placebo Tablet 10mg ZL65 Placebo Tablet 25mg ZL65 PlaceboTablet 50mg ZL65 Placebo Tablet 75mg ZL65 Placebo Tablet 100mg ZL65 Placebo Tablet 125mg
Incidence of adverse events
Time frame: day 1 to day 7
ZL65 Pharmacokinetics (PK):Cmax
Time frame: 0-72hours
ZL65 Pharmacokinetics (PK):Tmax
Time frame: 0-72hours
ZL65 Pharmacokinetics (PK):AUC0-t
Time frame: 0-72hours
ZL65 Pharmacokinetics (PK):AUC0-∞
Time frame: 0-72hours
ZL65 Pharmacokinetics (PK):t1/2
Time frame: 0-72hours
Started Jul 2026 (actual). Primary completion is estimated for Jul 2027, 12 months after the start.
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