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A phase I, randomized, double-blind, placebo-controlled, single, and multiple-dose escalation study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of JMKX003002 in healthy participants: a randomized, open-label, 3-period crossover food effect study

A phase I, randomized, double-blind, placebo-controlled, single, and multiple-dose escalation study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of JMKX003002 in healthy participants: a randomized, open-label, 3-period crossover food effect study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070473
Enrollment
Unknown
Registered
2023-04-13
Start date
2023-04-14
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hyperphosphatemia

Interventions

Single dose group:Oral JMKX003002 tablets or placebo
Multiple dose group:Oral medication 7 days

Sponsors

Huashan Hospital Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. No gender limmit, subjects aged 18-45 years (including boundary values); 2. After comprehensive physical examination (vital signs, physical examination), laboratory examination (blood routine, blood biochemistry, urine routine, coagulation routine), 12-lead electrocardiogram and other examinations, it was determined that there was no abnormality or abnormality had no clinical significance; 3. Understand the research procedures and methods, voluntarily participate in this experiment, comply with the relevant instructions of the study, and sign the informed consent in person.

Exclusion criteria

Exclusion criteria: 1. There is evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, liver, neuropsychiatric disorders, or any condition that the investigator has determined may affect drug absorption, distribution, metabolism, or excretion; 2. Have a history of malignant tumors or currently have malignant tumors; 3. Other conditions in which subjects are deemed unsuitable by the investigator.

Design outcomes

Primary

MeasureTime frame
Hematology;Chemistry;Coagulation function;

Secondary

MeasureTime frame
Pharmacokinetics;

Countries

China

Contacts

Public ContactZhang Jing, Xue Jun

Huashan Hospital Fudan University

zhanngj_fudan@163.com+86 21 52887926

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026