A phase I, randomized, double-blind, placebo-controlled, single-center study designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of single and multiple ascending doses of GDC-6599 and the effect of food on the pharmacokinetics and pharmacodynamics of GDC-6599 in healthy adult subjects - GDC-6599 SAD, FE and MAD study

Genentech, Inc.0 个研究点目标入组 92 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•- Signed Informed Consent Form
•- Age 18*75 years at time of signing Informed Consent Form
•- Ability to comply with the study protocol, in the investigator*s judgment
•- Body mass index of 18*30 kg/m2 at screening
•- Veins suitable for venipuncture and/or cannula insertion to accommodate blood
•sample collection at multiple timepoints during the study

•- Pregnant or breastfeeding, or intending to become pregnant during the study
•or within 14 days after the final dose of study drug during the SAD/FE stage
•and for 28 days after the final dose of study drug during the MAD stage, unless
•a longer period is required by local regulations or ethics committee
•Women must have a negative serum pregnancy test result within 1 day prior to
•initiation of study drug.
•- History of easy bruising or bleeding (i.e., bruising or bleeding out of
•proportion to the degree of trauma)
•- Use of anticoagulant or anti-platelet therapies
•- History of significant hepatic impairment, defined as Child-Pugh Class B or
•C, corresponding to a Child-Turcotte-Pugh Score >= 7
•- History of abuse, in the investigator's judgment, of drugs including, but not
•limited to the following: amphetamines, barbiturates, benzodiazepines, cocaine,
•marijuana/cannabis, methadone, methamphetamine, ecstasy, morphine/opiates,
•phencyclidine, and tricyclic antidepressants within 12 months prior to
•screening and clinic admission
•A positive drug screen test for any of the drugs listed above at screening is
•exclusionary.

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