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Safety and Efficacy of T89 in the Prevention and Treatment of Adults With Acute Mountain Sickness (AMS) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety and Efficacy of T89 in the Prevention and Treatment of Adults With Acute Mountain Sickness (AMS)

A Multicenter, Double-blind, Randomized and Placebo-controlled Pivotal Phase 3 Study to Evaluate the Safety and Efficacy of T89 in the Prevention and Treatment of Acute Mountain Sickness (AMS) After Rapid Ascent

NCT04993729•Tasly Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

The specific aim of this double blind, randomized phase III trial is to evaluate the safety and efficacy of T89 in preventing Acute Mountain Sickness (AMS) and relieving the symptoms of AMS after rapid ascent.

Detailed Description

Acute mountain sickness (AMS) is a common ailment in people venturing over 2,500 meters altitude. It is a pathological effect of high altitude on humans, caused by acute exposure to low partial pressure of oxygen at high altitude. It presents with a cluster of nonspecific symptoms including headache and one of the following: gastrointestinal symptoms, fatigue and/or weakness, dizziness/ lightheadedness or difficulty sleeping. T89 capsule is a modernized industrialized version of a traditional Chinese herbal medicine. It is a botanical drug product for oral use. Previous clinical studies showed T89 has substantial benefits in the prevention or amelioration of symptoms associated with acute mountain sickness (AMS).This is double-blind, randomized, placebo controlled pivotal phase 3 study. After informed consent is obtained, eligible subjects will be randomized to one of the 3 study groups (T89 high dose, T89 low dose and placebo control). The study drug will be given orally for 5 days (2 days at sea level and 3 days at high altitude). The clinical assessment of Lake Louise Scoring System (LLSS), blood oxygen saturation, the exercise tolerance, blood pressure and heart rate will be performed at sea level and altitude. A total of 846 subjects will be enrolled with 282 subjects in each treatment arm, and a minimum of 756 subjects are expected to complete the study.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy volunteers: ages 18 - 55 years old;
•2. Primary residence elevation of 2,461 ft (750m) or lower;
•3. Not ascending to altitude \>10,000 ft within 4 months prior to screening;
•4. Females of childbearing potential must have a negative pregnancy test and established on a method of contraception that in the investigator's opinion is acceptable. Females must agree to remain on their established method of contraception from the time of the screening visit and throughout the study period;
•5. Willing to participate voluntarily and sign a written informed consent.

Exclusion Criteria

•1. Subjects with medical history of cardiovascular, cerebrovascular diseases or asthma; uncontrolled hypertension with SBP\>140 and or DBP\>90 mmHg;
•2. Subjects with current and clinically significant respiratory system disease, digestive disease, liver disease, central nervous system disease, psychiatric disease, metabolic disease, renal disease, acute infection or anemia, or who test positive for COVID-19 (COVID testing will be performed, not per study requirement, but in compliance with local law or policy, and subject with known positive for COVID-19 will be excluded).
•3. Total LLSS score (LLSS score) is ≥2 at any check point during screening period;
•4. Blood oxygen saturation (SpO2), preferably tested on the left-hand index finger, is less than 95% at screening visits;
•5. Subjects with abnormal renal or liver function with clinical significance (ALT or AST \> 2×ULN, Creatinine \> ULN) at screening visit;
•6. Subjects with CRP \> ULN at screening visit;
•7. Subjects with primary (migraine, tension-type headache, and cluster headache etc.) or secondary headaches (headache related to infection, vascular disease etc.) within one month at screening;
•8. Surgery or blood donation within 3 months prior to screening;
•9. On treatment of any medications (including any dietary supplements) except for birth control within 14 days prior to screening and throughout the study period;
•10. Smokers who had a habit of smoking during the last 4 months prior to the starting of screening;
+6 more criteria

Locations (3)

Hypoxia Research Lab, UCSF Parnassus Campus, S-256

San Francisco, California, United States

Affiliated Hospital of Chengdu University of TCM

Chengdu, Sichuan, China

Tibet Autonomous Region People's Hospital

Lhasa, Tibet, China

Key Dates

Start Date

July 21, 2021

Primary Completion Date

May 26, 2023

Completion Date

May 26, 2023

Last Updated

August 13, 2024

Enrollment

853

ACTUAL participants

Conditions

Acute Mountain Sickness (AMS)

Interventions

T89 capsule

DRUG

Placebo capsule

DRUG

Evaluation of the Prevention and Treatment Effects of Chinese Medicine on High Altitude Illness

NCT01682551

Acute Mountain Sickness (AMS)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 13, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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