Study of the Tolerability and Pharmacokinetic of ZL-2102 With an Investigation of Food Effect in Healthy Male Subjects

• Status: Unknown status
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

The first-in-man study are designed as below to assess safety, tolerability, and preliminary pharmacokinetics of ZL-2102.

• Double-blind randomized, placebo-controlled ascending single oral doses (Part 1, ZL-2102-SAD);

• Open-label, randomized, 2-sequence, 2-period, 2-treatment crossover (Part 2, ZL-2102-FED);

• Double-blind randomized, placebo-controlled, ascending repeated oral doses for 14 days (Part 3, ZL-2102-MAD).

A total of 104 subjects will be enrolled.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Zai Lab Pty. Ltd.

Criteria

Inclusion Criteria:

• Male subject, between 18 and 45 years of age inclusive.

• Body weight between 50.0 and 100.0 kg inclusive, body mass index (BMI) between 18.0 and 30.0 kg/m² inclusive.

• Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).

• Normal vital signs after 5 minutes resting in a semi recumbent position.

• Normal standard 12-lead ECG after 5 minutes resting in a semi recumbent position.

• Laboratory parameters within the normal range, or considered not clinically significant by the Investigator.

• Subject returns a negative result to the Serology,Urine drug screen and alcohol breath tests.

• Having given written informed consent prior to any procedure related to the study.

• Not under any administrative or legal supervision.

• Males must agree to use adequate contraception for the duration of the study and for 3 months post completion of dosing.

• Subject agrees to the following study restrictions:

1. Subject will not consume citrus fruits and their juices for 5 days before the start of the study, and for the duration of the study.

2. Subject will not consume alcohol, tea, coffee, chocolate, quinine or caffeine-containing beverages from Day 1 and for the duration of the study.

3. Subject will note smoke or use tobacco from Day 1 and for the duration of the study.

4. Subject will avoid intensive physical activity from Day 1 and for the duration of the study.

Exclusion Criteria:

• Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteo-muscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.

• Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).

• Blood donation, any volume, within 2 months prior to Screening.

• Symptomatic postural hypotension, whatever the decrease in blood pressure, or asymptomatic postural hypotension defined by a decrease in systolic blood pressure ≥ 20 mmHg within 3 minutes when changing from the supine to the standing position.

• Presence or history of drug hypersensitivity, or allergic disease (excluding hay fever) diagnosed and treated by a physician.

• History or presence of drug or alcohol abuse (alcohol consumption >40 grams per day).

• Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.

• Excessive consumption of beverages with xanthine bases (>4 cups or glasses per day).

• Any prescription medication within 14 days and any over the counter medication within 7 days before Screening or within 5 times the elimination half-life or Pharmacodynamic half-life of that drug whichever is longest unless approved by both the Investigator and the Medical Monitor; any vaccination within the last 28 days. If necessary, paracetamol (acetaminophen) may be administered with the approval of the Investigator.

• Any subject who, in the judgment of the Investigator, is likely to be non-compliant during the study, or unable to cooperate because of a language problem or poor mental development.

• Receipt of any investigational study drug within 30 days prior to screening.

• Any subject who is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in the conduct of the protocol.