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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02397005




Registration number
NCT02397005
Ethics application status
Date submitted
27/02/2015
Date registered
24/03/2015
Date last updated
24/01/2019

Titles & IDs
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
Secondary ID [1] 0 0
ZL-2102-SAD/FED/MAD
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
Asthma 0 0
Idiopathic Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ZL-2102
Treatment: Drugs - Placebo matching ZL-2102

Active Comparator: ZL-2102 - Planned to be administrated in an ascending manner: 5,20,60,150,300,500,750mg

Placebo Comparator: Placebo - Placebo matching ZL-2102


Treatment: Drugs: ZL-2102
A selective and reversible inhibitor of Hematopoietic Prostaglandin D Synthase (HPGDS).

Treatment: Drugs: Placebo matching ZL-2102
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part1,ZL-2102-SAD: Safety as measured by Adverse Events
Timepoint [1] 0 0
8 days
Primary outcome [2] 0 0
Part2,ZL-2102-FED: Safety as measured by Adverse Events
Timepoint [2] 0 0
15 days
Primary outcome [3] 0 0
Part3,ZL-2102-MAD: Safety as measured by Adverse Events
Timepoint [3] 0 0
21 days
Primary outcome [4] 0 0
Peak Plasma Concentration (Cmax) of ZL-2102
Timepoint [4] 0 0
48 hours
Primary outcome [5] 0 0
Area under the plasma concentration versus time curve (AUC) of ZL-2102
Timepoint [5] 0 0
48 hours
Secondary outcome [1] 0 0
Part1,ZL-2102-SAD: Safety as measured by Physical examination, body weight, hematology, biochemistry, urinalysis, vital signs and 12-lead ECG.
Timepoint [1] 0 0
8 days
Secondary outcome [2] 0 0
Part2,ZL-2102-FED: Safety as measured by Physical examination, body weight, hematology, biochemistry, urinalysis, vital signs and 12-lead ECG.
Timepoint [2] 0 0
15 days
Secondary outcome [3] 0 0
Part3,ZL-2102-MAD: Safety as measured by Physical examination, body weight, hematology, biochemistry, urinalysis, vital signs and 12-lead ECG.
Timepoint [3] 0 0
21 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2019
Actual
Sample size
Target
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Linear Clinical Research Unit - Perth
Recruitment postcode(s) [1] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Zai Lab Pty. Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02397005
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02397005