Army Drug Development Program. Phase I. Clinical Testing.
Annual rept. Jan 82-Jan 83,
BIO-MED INC COLLEGE PARK MD
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In a double-blind study of safety and tolerance, 44 healthy male subjects were each given from 1000 to 2500 mg of the drug WR 194,965H3P04, or placebo, in 3 doses over a period of 24 hours. Symptomatology, physical status, laboratory tests, phototoxicity and electrocardiographic rhythm strips were used to study the safety and tolerance of the drug. At the highest dose level, one subject who received the drug had moderately debilitating gastrointestinal symptoms the other had marked light-headedness. Mild, non-debilitating symptoms were noted in drug recipients at the lower dose level. Placebo subjects had the expected array of non-specific complaints. The other variables observed showed no consistent differences between drug and placebo subjects. The drug was well-tolerated at 2000 mg with no reported symptoms it appeared to produce mild symptoms at 2250 mg and significant symptoms at 2500 mg.