A Study of PN20 in Healthy Adult Volunteers (NCT06523088) | Clinical Trial Compass
CompletedPhase 1
A Study of PN20 in Healthy Adult Volunteers
China27 participantsStarted 2022-06-16
Plain-language summary
The main aim of this clinical trial is to assess the safety of PN20 in healthy volunteers aged 18 to 50 years. The main questions it aims to answer are:
* Is PN20 safe in adult? Researchers will compare PN20 to a placebo (a look-alike substance that contains no drug) to see if PN20 is safe.
Participants will
* Receive a single dose injection of PN20 or placebo according to weight,
* Stay in hospital for assessment.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Healthy male or female subjects aged 18 to 50 years;
✓. Body mass index between 19.0-28.0 (inclusive), body mass index (BMI) = weight (kg)/height\^2 (m\^2);
✓. Female subjects of childbearing age with negative serum pregnancy test results;
✓. Platelet counts during the screening period and one day before enrollment are within the range of 100-300×10\^9/L;
✓. Eligible subjects of fertility must agree to use effective contraceptive measures or abstain from sex within 6 months after receiving the investigational drug;
✓. Be able to understand and comply with the requirements of the protocol and expected to complete the entire trial process;
✓. Voluntarily participate and sign the informed consent form.
Exclusion criteria
✕. Abnormal results of vital signs examination with clinical significance determined by the investigator;
✕. Positive test results for HIV-Ab, HCV-Ab, HBsAg, HBeAg, or treponema pallidum antibodies;
✕. Abnormal results of laboratory test (blood routine, urine routine, blood biochemistry, coagulation) with clinical significance determined by the investigator;
✕. Abnormal electrocardiogram with clinical significance or prolonged QT/QTc interval is, such as QTcB ≥ 430ms (male), or QTcB ≥ 450ms (female) (machine reading results); family history of QT prolongation;
✕. Positive drug abuse test or alcohol test ≥20mg/dL;
✕. Abnormal results of chest CT or COVID-19 screening (nucleic acid and C-reactive protein) with clinical significance determined by the investigator;
✕. Have taken any drugs (including prescription drugs, over-the-counter drugs and Chinese herbal medicines) within 4 weeks before enrollment, except for external drugs that are not absorbed by the body;
✕. Have used drugs known to cause significant damage to certain organs within 12 weeks before enrollment;