NCT02397005

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

Status unknown Phase 1 Last updated 22 January 2019

What this trial tests

Phase 1 trial testing ZL-2102 in Chronic Obstructive Pulmonary Disease in 120 participants. Status unknown.

Timeline

1 March 2015

Primary endpoint
1 April 2016

1 August 2019

Quick facts

Lead sponsor	Zai Lab Pty. Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	120
Start date	1 March 2015
Primary completion	1 April 2016
Estimated completion	1 August 2019
Sites	1 location across Australia

Drugs / interventions tested

• ZL-2102 — full drug profile →
• Placebo matching ZL-2102 — full drug profile →

Conditions studied

• Chronic Obstructive Pulmonary Disease — all drugs for Chronic Obstructive Pulmonary Disease →
• Asthma — all drugs for Asthma →
• Idiopathic Pulmonary Fibrosis — all drugs for Idiopathic Pulmonary Fibrosis →

Sponsor

Zai Lab Pty. Ltd. — full company profile →

Who can join

Adults 18 to 45, male only, with Chronic Obstructive Pulmonary Disease or Asthma. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Part1,ZL-2102-SAD: Safety as measured by Adverse Events
  Time frame: 8 days
• Part2,ZL-2102-FED: Safety as measured by Adverse Events
  Time frame: 15 days
• Part3,ZL-2102-MAD: Safety as measured by Adverse Events
  Time frame: 21 days
• Peak Plasma Concentration (Cmax) of ZL-2102
  Time frame: 48 hours
• Area under the plasma concentration versus time curve (AUC) of ZL-2102
  Time frame: 48 hours

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting fibrosis, mechanisms and cilinical trials.
   Zhao M, Wang L, Wang M, Zhou S, et al · · 2022 · cited 352× · PMID 35773269 · DOI 10.1038/s41392-022-01070-3
2. Emerging Role of Phospholipase-Derived Cleavage Products in Regulating Eosinophil Activity: Focus on Lysophospholipids, Polyunsaturated Fatty Acids and Eicosanoids.
   Knuplez E, Sturm EM, Marsche G. · · 2021 · cited 11× · PMID 33919453 · DOI 10.3390/ijms22094356
3. Activated T Cells Break Tumor Immunosuppression by Macrophage Reeducation.
   Trotta R, Rivis S, Zhao S, Orban MP, et al · · 2025 · cited 9× · PMID 40094380 · DOI 10.1158/2159-8290.cd-24-0415
4. The COPD Pipeline XXXVI.
   Gross N. · · 2017 · cited 2× · PMID 29354676 · DOI 10.15326/jcopdf.4.4.2017.0164