CJC-1295 (DAC) Side Effects and Safety

Safety & Tolerability

In the one published human clinical study of CJC-1295 with DAC — a Phase I dose-escalation trial in healthy adults — tolerability was characterized as good, with injection-site reactions reported as the most common adverse effect. No quantitative human safety data beyond this exists, and long-term safety is uncharacterized. Human data: Human evidence is limited to a single published Phase I/II pharmacokinetic-pharmacodynamic dose-escalation study in healthy adults; no efficacy trials, long-term safety studies, or regulatory review have followed. Sustained GHRH-receptor stimulation raises a theoretical concern about pituitary desensitization or feedback suppression, which the published study noted but did not observe within its window. Regulatory status: Not approved for any medical use by any regulatory agency; available only as a research compound. In the published Phase I dose-escalation study in healthy adults, CJC-1295 with DAC showed good tolerability, with injection-site reactions reported as the most common adverse effect. Human PK In the published Phase I dose-escalation study in healthy adults, CJC-1295 with DAC showed good tolerability, with injection-site reactions reported as the most common adverse effect. Sustained GHRH-receptor activation could theoretically cause receptor downregulation or feedback suppression of endogenous GH secretion; the 2006 clinical study noted this concern but did not observe pituitary desensitization within its study window. Human PK Sustained GHRH-receptor activation could theoretically cause receptor downregulation or feedback suppression of endogenous GH secretion; the 2006 clinical study noted this concern but did not observe pituitary desensitization within its study window.