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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02397005
• Date of registration: 27/02/2015
• Prospective Registration: Yes
• Primary sponsor: Zai Lab Pty. Ltd.
• Public title: Study of the Tolerability and Pharmacokinetic of ZL-2102 With an Investigation of Food Effect in Healthy Male Subjects
• Scientific title: Randomized, Double-blind, Placebo-controlled Study of the Tolerability and Pharmacokinetics of Ascending Single and 14-day Repeated Oral Doses of ZL-2102 With a Pilot Investigation of Food Effect in Healthy Male Subjects
• Date of first enrolment: March 2015
• Target sample size: 120
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02397005
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Australia

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease

Asthma

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: ZL-2102

Drug: Placebo matching ZL-2102

Primary Outcome(s)

Part2,ZL-2102-FED: Safety as measured by Adverse Events [Time Frame: 15 days]

Part1,ZL-2102-SAD: Safety as measured by Adverse Events [Time Frame: 8 days]

Part3,ZL-2102-MAD: Safety as measured by Adverse Events [Time Frame: 21 days]

Area under the plasma concentration versus time curve (AUC) of ZL-2102 [Time Frame: 48 hours]

Peak Plasma Concentration (Cmax) of ZL-2102 [Time Frame: 48 hours]

Secondary Outcome(s)

Part3,ZL-2102-MAD: Safety as measured by Physical examination, body weight, hematology, biochemistry, urinalysis, vital signs and 12-lead ECG. [Time Frame: 21 days]

Part1,ZL-2102-SAD: Safety as measured by Physical examination, body weight, hematology, biochemistry, urinalysis, vital signs and 12-lead ECG. [Time Frame: 8 days]

Part2,ZL-2102-FED: Safety as measured by Physical examination, body weight, hematology, biochemistry, urinalysis, vital signs and 12-lead ECG. [Time Frame: 15 days]

Secondary ID(s)

ZL-2102-SAD/FED/MAD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors