Low dose group. 225 mg will be taken for duration of study

High dose group. This group will take a placebo for 12 days before going to altitude and will switch to 300 mg 2 days before being at altitude and will continue the 300 mg dose at altitude.

Acute Mountain Sickness

The study drug will be given orally for 14 days (Days 1-14) as pre-treatment before ascending, followed by a 5-day high-altitude treatment and observation period (Days 15-19).

T89 225 mg group

Placebo

For the pre-treatment period in the T89 300 mg group, subjects will take placebo on Days 1-12, and take T89 (300 mg, BID) on Days 13-19.

T89 300 mg group

UCSF

T89 in Prevention and Treatment of Acute Mountain Sickness (AMS) During Rapid Ascent

A Double-blind, Randomized and Placebo-controlled Phase 2 Study to Evaluate the Safety and Efficacy of T89 in Prevention and Treatment of Acute Mountain Sickness (AMS) During Rapid Ascent

The self reported and clinical assessment of Lake Louise Scores will be compared between the placebo group and the T89 treatment group. The Lake Louise Scoring System (LLSS) is used to diagnose Acute Mountain sickness (AMS). The self reported LLSS asks a sojourner to altitude whether or not they have any of the hallmark signs of AMS and to rate the severity on a scale of 0-3, 0 being no symptoms and 3 being severe. These hallmark signs include Headache, Gastrointestinal symptoms, Fatigue and weakness, Dizziness and lightheadedness, and Difficulty sleeping. A Lake Louise score of 3-5 signifies mild AMS and >6 signifies severe AMS. The clinical assessment of the Lake Louise score includes checking sojourners for Ataxia, Edema and changes in mental status. These are also rated on a scale from 0 to 3 with 0 being asymptomatic and 3 being severe.

borneol/sembap

T89 in Prevention and Treatment of Acute Mountain Sickness (AMS) During Rapid Ascent

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