Safety, Pharmacokinetic and Pharmacodynamic Study of the CDK 4/6 Inhibitor G1T28-1

First-In-Human Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Study of G1T28-1 in Healthy Male and Female Subjects

This first-in-human (FIH) study will provide the first safety, PK, and PD data of G1T28-1 in humans and will allow further development of G1T28 1 in patients with cancer to reduce chemotherapy-induced myelosuppression.

Inclusion Criteria:

• Healthy male and female volunteers, 18-60 years of age; no clinically significant findings reported following detailed physical examination, medical history, vital signs, clinical laboratory tests, and ECGs as deemed by the PI
• Body mass index (BMI) in the range of 18 to 32 kg/m2 (inclusive) and weighing at least 50 kg
• Non-smokers / non-users of nicotine containing products for at least the previous 3 months
• Agreement to use birth control during the study and 3 months post last visit
• Able to comply with all protocol requirements and procedures

Exclusion Criteria:

• Clinically significant abnormalities found during physical examination, medical history review, ECGs (including QTcf interval > 450 msec), vital signs and laboratory tests (including positive test for HIV, hepatitis B and/or C)
• History of any serious allergic reaction to any medication
• Participated in a previous clinical trial with an investigational product in the last 60 days
• Any blood or plasma donation or other loss of blood at a volume exceeding 500 mL within 3 months before dosing
• History of drug or alcohol abuse in the last 2 years and positive test for drug abuse
• Use of any systemic medication within the past 2 weeks, including use of herbal products
• Pregnant or lactating women
• Any other issue which, in the opinion of the PI, will make the subject ineligible for study participation