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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06308523
Other study ID # AP303-PK-02
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 18, 2024
Est. completion date May 13, 2024

Study information

Verified date May 2024
Source Alebund Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will be a single center, double-blind, randomized, placebo-controlled, multiple-ascending-dose study to evaluate the safety, tolerability, PK and PD of AP303 following 2-week oral administration to healthy Chinese participants.


Description:

Eligible study participants will be enrolled and randomized into one of the two dose cohorts, each cohort will include 9 participants randomized to AP303 and placebo at 2:1 ratio (6 on AP303 and 3 on placebo).


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date May 13, 2024
Est. primary completion date May 8, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Important Inclusion Criteria: 1. Healthy male and female participants, 18-50 years of age. 2. BMI (body mass index) 18-27 kg/m2. Important Exclusion criteria: 1. History or symptoms of any clinically significant kidney, liver, broncho-pulmonary, gastrointestinal, neurological, psychiatric, cardiovascular, endocrine/metabolic, hematological disease or cancer. 2. Personal history of congenital long QT syndrome or family history of sudden death. 3. People with a history of specific severe allergies, or severe allergic conditions or known allergies to the study or any of its ingredients or excipients as judged by the investigator, or any acute confirmed significant allergic reactions to any drug, or multiple drug severe allergies (non-active hay fever is acceptable). Allowing for childhood asthma, history of mild eczema that has had no flare ups for =5 years or is fully resolved. 4. History of having received or currently receiving any systemic anti-neoplastic or immunomodulatory treatment (including systemic oral or inhaled corticosteroids) =6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study. 5. Participants who have had significant acute infection, e.g., COVID-19, influenza, local infection, acute gastrointestinal symptoms or any other clinically significant illness within two weeks before study drug administration. 6. Confirmed systolic BP greater than 140 or less than 90 mmHg, and diastolic BP greater than 90 or less than 50 mmHg at screening. 7. Abnormalities of ECG parameters and abnormal shape of ECG wave on screening ECG. 8. Implantation of cardiac pacemaker or clinically significant arrhythmias. 9. Estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m2 (using the CKD-EPI equation). 10. Positive test at screening of any of the following: Hepatitis B (HBsAg), Hepatitis C (HCVAb), human immunodeficiency virus (HIV Ab) or syphilis AB. 11. ALT or AST >1.5 × ULN, or any other clinically significant abnormalities in laboratory test results at screening. 12. Dosed with a small-molecule or biologic investigational drug within 30 days or 90 days, respectively, or 5 half-lives whichever is the longer) prior to first dose of this study. 13. Donation of component (plasma or platelet) or whole blood =200 mL within 4 weeks prior to screening. 14. Receipt of a live vaccine within 4 weeks of prior to screening (Influenza and COVID-19 vaccines are allowed). 15. Positive urine test for drugs of abus. 16. History of drug and/or alcohol abuse or addiction. 17. History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol). Alcohol consumption within 48 hours before screening. 18. Use of >5 cigarettes or equivalent nicotine-containing product per day. 19. Taking any prescribed or over-the-counter medications (including vitamins or herbal remedies) within 30 days or 5 half-lives (whichever is the longer) of the first dose of study drug. Occasional paracetamol is allowed (see section on Permitted Therapy). Exceptions may be made on a case-by-case basis following discussion and agreement between the investigator and the sponsor. 20. Medical or social conditions that would potentially interfere with the participant's ability to comply with the study visit schedule or the study assessments.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AP303 150 µg
AP303 Tablet 150 µg QD
Placebo 150 µg
Placebo Tablet 150 µg QD
AP303 300 µg
AP303 Tablet 300 µg QD
Placebo 300 µg
Placebo Tablet 300 µg QD

Locations

Country Name City State
China Peking University Third Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Alebund Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cmax Maximum observed plasma concentration Day 1, Day 3-14
Primary Tmax Time to maximum observed plasma concentration Day 1, Day 3-14
Primary AUC0-24h Area under the plasma concentration versus time curve up to 24 hours Day 1
Primary AUC0-last Area under the plasma concentration versus time curve up to the last measurable concentration Day 1
Primary AUC0-inf Area under the plasma concentration versus time curve extrapolated to infinity Day 1
Primary AUC0-t Area under the plasma concentration-time curve for a dosing interval Day 3-14
Primary t1/2 Apparent terminal half-life, computed as ln(2)/?z Day 1, Day 3-14
Primary CL/F Apparent oral clearance calculated from Dose/ AUC0-inf Day 1
Primary V/F Apparent volume of distribution of oral drug Day 1, Day 3-14
Primary Cav average plasma concentration Day 3-14
Primary Ctrough Trough plasma concentration Day 3-14
Primary Rac Ratio of accumulation Day 3-14
Primary Incidence and severity of adverse events Incidence and severity of adverse events Day 1-28
Primary Incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation and urinalysis test results Incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation and urinalysis test results Day 1-28
Primary Effect of AP303 on ECG parameters Heart rate in beats/min Day 1-28
Primary Effect of AP303 on ECG parameters QT in ms Day 1-28
Primary Effect of AP303 on ECG parameters PR in ms Day 1-28
Primary Effect of AP303 on ECG parameters QRS in ms Day 1-28
Primary Effect of AP303 on ECG parameters QTcF in ms Day 1-28
Primary Effect of AP303 on ECG parameters QTcB in ms Day 1-28
Primary Vital signs Effect of AP303 on vital signs, e.g. blood pressure Day 1-28
Primary Effect of AP303 on physical examination result nature, frequency, and severity of abnormality of physical examination result Day 1-28
Primary body weight Effect of AP303 on body weight, e.g. change of body weight after administration of AP303 Day 1-28
Secondary Fasting glucose Fasting glucose Baseline, Days 5, 10, 14 and 28
Secondary Fasting lipid profile Triglyceride, HDL-C, LDL-C, Total cholesterol Baseline, Days 5, 10, 14 and 28
Secondary Serum creatinine Serum creatinine Baseline, Days 5, 10, 14 and 28
Secondary eGFR Estimated glomerular filtration rate Baseline, Days 5, 10, 14 and 28
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