Acute Mountain Sickness
Conditions
Interventions
Treatment Group:Enarsentan
Control Group:Enarsentan Placebo
Sentinel Group:Enarsentan
Sponsors
Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Fully understood this study and voluntarily signed the written informed consent form, and are able to comply with the requirements and restrictions listed in the informed consent form; 2. Male or female aged 18 to 65 years (including 18 and 65 years); 3. At screening, males weigh >= 50 kg, females weigh >= 45 kg, and body mass index (BMI) is between 19.0 and 30.0 kg/m^2 (including 19.0 kg/m^2 and 30.0 kg/m^2); 4. The primary residence is in a low-altitude area (750 meters or below); 5. At the time of screening, all examinations (including physical examination, vital signs check, blood routine, urine routine, blood biochemistry, coagulation function, C-reactive protein, 12-lead ECG, chest radiograph, etc.) show no abnormalities or only minor abnormalities judged by the investigator to be clinically insignificant; 6. The study participant or their partner has no pregnancy plans from the signing of the informed consent to three months after the last administration of the investigational drug, voluntarily uses effective contraception (see Appendix 1; the use of contraceptive pills is prohibited during the study) to avoid pregnancy for themselves or their partner, and the study participant does not donate sperm or eggs (oocytes, oocyte cells) for reproductive or assisted reproductive purposes.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, or women of childbearing potential (criteria for assessing childbearing potential are detailed in Appendix 1) with a positive pregnancy screening result; 2. History of clinically significant acute drug or food allergic reactions within 2 weeks prior to screening, or allergic constitution (such as allergy to two or more drugs, foods, or pollens), or history of atopic disease (such as asthma, urticaria, atopic dermatitis, etc.), or judged by the investigator to possibly or clearly have an allergy, hypersensitivity, or clinically significant reaction to the investigational drug (including similar drugs or control drugs) or any of its excipients; 3. At any time before screening and first dosing, LLSS self-reported total score >= 2 points; 4. Reached a high-altitude area (above 2,500 meters) within 2 years prior to screening or visited high-altitude areas more than once in the past; 5. History of severe high-altitude illness or family history of severe high-altitude illness. 6. Participants with the following diseases or medical history: (1) Participants with cardiovascular diseases (such as arrhythmia, heart failure, pulmonary hypertension), cerebrovascular diseases (such as cerebral hemorrhage, cerebral infarction), or a history of these conditions; (2) Participants with thromboembolism (such as pulmonary embolism, deep vein thrombosis) or a history of these conditions; (3) Participants with respiratory diseases such as asthma, pulmonary tuberculosis, chronic bronchitis, emphysema, or a history of these conditions; (4) Participants with acute or chronic neurological or psychiatric disorders (such as fatigue syndrome not caused by high-altitude hypoxia, sleep disorders, severe anxiety, severe depression, etc.) that have not been cured; (5) Participants with age-related macular degeneration, proliferative choroidal or retinal diseases, or a history of these ocular lesions; (6) Participants who have had a cold, fever, or respiratory infection (such as viral or bacterial infection) within 2 weeks before the first dose; (7) Participants who frequently suffered from primary headaches (such as migraine, tension-type headache, or cluster headache) or secondary headaches (such as headaches caused by infection or vascular disease); (8) Participants who have had severe motion sickness in the past 5 years, which may significantly affect study assessments. 7. Systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg at screening; 8. Peripheral oxygen saturation (SpO2) 165 g/L for men, >140 g/L for women at screening; 10. Transferrin saturation (TSAT) <20% at screening. 11. Abnormal coagulation function judged by the investigator during screening that is clinically significant; 12. Any of the following test results during screening are positive: hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or Treponema pallidum antibody; 13. Using any of the following foods, drugs, or treatments before the first dose: (1) Use of any prescription drugs, Chinese herbal medicine, over-the-counter drugs, or dietary supplements (including vitamins, health products, etc.) within 1 week before the first dose; (2) Consumption of foods or drinks containing alcohol, caffeine, or xanthine within 72 hours before the first dose. 14. Drug or substance abuse, alcohol abuse, or smoking: (1) History of drug or substance abuse, or positive drug abuse screening result during sc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of AMS; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change level of LLSS score compared with baseline;Percentage reduction in LLSS score at 6 h post-high-altitude arrival relative to Day 15;The change level of GJB 1098-91 score compared with baseline;AMS clinical function score;Incidence of moderate to severe AMS, HAPE, and HACE;Cumulative incidence of participants receiving rescue therapy;Time to onset of AMS;MS incidence rate;Change in SpO2 from baseline; | — |
Countries
China
Contacts
Public ContactZeng Jieping
Hospital of Chengdu University of Traditional Chinese Medicine
Outcome results
None listed