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Phase-I study of diacetyl-splenopentin (BCH 069).
1Institute of Clinical Immunology, Friedrich Schiller University, Jena.
Allergie Und Immunologie
|January 1, 1990
Summary
BCH 069, a synthetic pentapeptide, showed thymic hormone-like activity. This well-tolerated drug demonstrated clinical and biochemical effects, with administration route influencing side effects but not biochemical changes.
Area of Science:
- Pharmacology
- Immunology
Background:
- BCH 069 is a novel synthetic pentapeptide.
- It exhibits thymic hormone-like activity.
Purpose of the Study:
- To evaluate the clinical and biochemical effects of BCH 069.
- To assess the safety and tolerability of BCH 069 in patients during the pollen season.
Main Methods:
- Two groups received 50 mg BCH 069 or placebo subcutaneously for 4 weeks.
- A third group received 50 mg BCH 069 intravenously for 6 weeks.
- Therapy was administered during peak pollen season.
Main Results:
- Intravenous administration of 50 mg/10 ml caused flushing; not observed with 50 mg/20 ml.
- Observed decreases in triglyceride, SGOT, and SGPT serum levels.
- Observed increases in lipase serum level and decreases in hemoglobin.
- Biochemical changes remained within normal laboratory values.
- No disease-specific inflammatory changes were noted in the intravenous group.
Conclusions:
- The administration route impacts clinical side effects but not drug-induced biochemical changes.
- BCH 069 is a well-tolerated drug with potential therapeutic applications.