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

NCT04993729 | Completed Phase 3 FDA Drug

• 1 other identifier: T89-31-AMS
• Study Type: interventional
• Target: 853
• Locations: 2 countries
• Sites: 3

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.

Conditions

Acute Mountain Sickness (AMS)

Keywords

Acute Mountain Sickness

Outcome Measures

Primary Outcomes (1)

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

  2018 Lake Louise Scoring System (LLSS) score \[0-12\] will be used in this primary outcome assessment. The higher LLSS scores mean the worse symptoms of AMS. Baseline will be the average of LLSS scores on Day 2 and the one on Day 3 before breakfast.

  Baseline and day 4

Secondary Outcomes (11)

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

  Baseline and days 3-6

• The change of the area under the curve (AUC) of baseline corrected LLSS score-time profile between T89 and placebo groups.

  Baseline and days 3-6

• The change in total incidence of LLSS score ≥5 on Day 4 morning between T89 and placebo groups.

  Day 4 morning

• The change of percentage reduction of the daily total LLSS score from Day 4 to Day 5 between T89 and placebo groups.

  Days 4-5

• The change of baseline corrected LLSS score at any given time points between T89 and placebo groups.

  Baseline and days 3-6

Study Arms (3)

T89 low-dose group

EXPERIMENTAL

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

Drug: T89 capsule; Drug: Placebo capsule

T89 high-dose group

EXPERIMENTAL

Subjects in this group will take four T89 capsules each time by oral administration three times daily for 5 days.

Drug: T89 capsule

Placebo group

PLACEBO COMPARATOR

Placebo capsule does not contain any amount of active substance. Subjects in this group will take four placebo capsules each time by oral administration three times daily for 5 days.

Drug: Placebo capsule

Interventions

T89 capsule DRUG

T89 capsule (trade name Dantonic®) is a botanical drug containing 75mg active substance which is the water extract of Danshen and Sanqi. T89 capsules, p.o. TID.

T89 high-dose group; T89 low-dose group

Placebo capsule DRUG

Placebo capsules, p.o. TID.

Placebo group; T89 low-dose group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers: ages 18 - 55 years old;
• Primary residence elevation of 2,461 ft (750m) or lower;
• Not ascending to altitude \>10,000 ft within 4 months prior to screening;
• 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;
• Willing to participate voluntarily and sign a written informed consent.

You may not qualify if:

• Subjects with medical history of cardiovascular, cerebrovascular diseases or asthma; uncontrolled hypertension with SBP\>140 and or DBP\>90 mmHg;
• 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).
• Total LLSS score (LLSS score) is ≥2 at any check point during screening period;
• Blood oxygen saturation (SpO2), preferably tested on the left-hand index finger, is less than 95% at screening visits;
• Subjects with abnormal renal or liver function with clinical significance (ALT or AST \> 2×ULN, Creatinine \> ULN) at screening visit;
• Subjects with CRP \> ULN at screening visit;
• 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;
• Surgery or blood donation within 3 months prior to screening;
• On treatment of any medications (including any dietary supplements) except for birth control within 14 days prior to screening and throughout the study period;
• Smokers who had a habit of smoking during the last 4 months prior to the starting of screening;
• Contradictive to treatment of Danshen (Radix Saliva Miltiorrhize Bge., RSM) products;
• Women who are pregnant or lactating.
• 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;
• Participation in any other interventional clinical trial or on an investigational drug within 30 days prior to screening;
• A family member or relative of the study site staff;

Sponsors & Collaborators

• Tasly Pharmaceuticals, Inc.: lead

Study Sites (3)

Hypoxia Research Lab, UCSF Parnassus Campus, S-256

San Francisco, California, 94143, United States

Location

Affiliated Hospital of Chengdu University of TCM

Chengdu, Sichuan, 610032, China

Location

Tibet Autonomous Region People's Hospital

Lhasa, Tibet, 850000, China

Location

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Henry H Sun, PhD, MD

  Tasly Pharmaceuticals, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 6, 2021
• Study Start: July 21, 2021
• Primary Completion: May 26, 2023
• Study Completion: May 26, 2023
• Last Updated: August 13, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CN (2)