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Toxicity studies with human fibroblast interferon
Archives of Toxicology. Supplement. = Archiv Fur Toxikologie. Supplement
|January 1, 1983
Summary
Acute toxicity studies show that fibroblast-derived human interferon (FHIF) is safe for use. FHIF demonstrated no severe toxic effects in mice and rats, and was well-tolerated in rabbits and monkeys.
Area of Science:
- Biochemistry
- Pharmacology
- Toxicology
Background:
- Interferons are crucial for immune response.
- Fibroblast-derived human interferon (FHIF) is a therapeutic agent.
- Assessing the safety of FHIF is essential before human application.
Purpose of the Study:
- To evaluate the acute toxicity and pharmacological safety of FHIF.
- To determine the safety profile of FHIF in preclinical animal models.
- To establish the safety of FHIF for proposed human dosage.
Main Methods:
- Acute toxicity studies in mice and rats (14-day observation).
- Local innocuity tests in rabbits (intravenous, intra-arterial, paravenous).
- Pyrogenicity and Limulus tests in rabbits.
- Pharmacological safety assessment in monkeys (Macaca fascicularis).
Main Results:
- No severe toxic effects or pathological clinical signs observed in mice and rats.
- FHIF showed no adverse effects in local innocuity studies in rabbits.
- Monkeys tolerated FHIF well, with minor transient effects at higher doses.
- Low lipopolysaccharide (LPS) content confirmed in FHIF.
Conclusions:
- FHIF is safe in acute toxicity studies across multiple animal models.
- The proposed human dose of FHIF is considered safe based on preclinical data.
- FHIF exhibits a favorable safety profile with low endotoxin levels.