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

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Brief Title

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

Official Title

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

Brief 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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Change of baseline corrected mean LLSS score on Day 4 morning (next mornings after arrival at high altitude) between T89 and placebo groups.

Secondary Outcome

 The change of blood oxygen saturation levels (SpO2) at high altitude between T89 and placebo groups.

Condition

Acute Mountain Sickness (AMS)

Intervention

T89 capsule

Study Arms / Comparison Groups

 T89 low-dose group
Description:  Subjects in this group will take three T89 capsules and one Placebo capsule each time by oral administration three times daily for 5 days.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

846

Start Date

July 21, 2021

Completion Date

April 2024

Primary Completion Date

December 2023

Eligibility Criteria

        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;

         11. Contradictive to treatment of Danshen (Radix Saliva Miltiorrhize Bge., RSM) products;

         12. Women who are pregnant or lactating.

         13. Substance abuse. Subjects with a recent (within the last 6 months) history of
             substance abuse (alcohol, marijuana, or known drug dependence). Or subjects who have a
             positive urine substance test at screening;

         14. Participation in any other interventional clinical trial or on an investigational drug
             within 30 days prior to screening;

         15. A family member or relative of the study site staff;

         16. Any condition that, in the opinion of the investigator, is likely to prevent
             compliance with the study protocol, interfere with the assessment, or pose a safety
             concern if the subject participates in the study at screening.

Gender

All

Ages

18 Years - 55 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jeffrey W Sall, PhD, MD, 415-476-0322, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT04993729

Organization ID

T89-31-AMS

Responsible Party

Sponsor

Study Sponsor

Tasly Pharmaceuticals, Inc.

Study Sponsor

Jeffrey W Sall, PhD, MD, Principal Investigator, Department of Anesthesia and Perioperative Care, University of California, San Francisco, CA, U.S.

Verification Date

August 2021