Phase-I study of diacetyl-splenopentin (BCH 069).

BCH 069 is a new synthetic pentapeptide with thymic hormone-like activity. Two groups of patients received 50 mg BCH 069 or placebo by subcutaneous injection for 4 weeks 3 times weekly. The third group of patients received 50 mg BCH 069 by intravenous injection for 6 weeks 3 times weekly. The therapy was carried out during the peak of the pollen season. We observed the following clinical and biochemical activities of BCH 069: - flush symptom with a feeling of heat during intravenous administration of 50 mg/10 ml but not during 50 mg/20 ml, - decrease of triglyceride serum level, - decrease of SGOT- and SGPT serum levels, - increase of lipase serum level, - decrease of hemoglobin. - All changes of the biochemical parameters were not outside of the normal laboratory values. The disease-specific inflammatory changes were not seen in the intravenously treated group. The administration route is very important for the clinical side effect but not for drug induced biochemical changes. It can be concluded that BCH 069 is a well tolerated drug.