Dose-escalation and Food Effect Study of ZT006 in Healthy, Overweight and Obese Participants

Summary

ZT006 is an oral, long-acting glucagon-like peptide-1. This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ZT006 in healthy, overweight and obese participants. The study comprises three parts, i.e. single dose-escalation, multiple dose-escalation, food effect on the pharmacokinetics of ZT006.

In the single dose-escalation study, participants will receive a single dose (ZT006 dose level 1 - 5 or corresponding placebo) of ZT006 under fasted condition. A higher dose can only be given after obtaining acceptable safety and tolerability data for at least 7 days after the previous dose. After study drug administration, there will be a 7-day in-house period for safety observation and pharmacokinetics samples collection. Participants will join ambulatory visits until 42 days post-dose.

In the multiple dose-escalation study, participants will receive a daily dose of ZT006 or corresponding placebo over 42 days in a dose up-titration fashion according to the following regimen:

* Cohort 1: dose level 1 - dose level 2 - dose level 3
* Cohort 2: dose level 1 - dose level 2 - dose level 3 - dose level 4
* Cohort 3: dose level 2 - dose level 3 - dose level 4
* Cohort 4: dose level 2 - dose level 3 - dose level 4 - dose level 5

Dosing of a cohort with higher drug exposure can only be done after evaluation of safety and tolerability data for at least 14 days after the first dose in the previous cohort. Participants will join ambulatory visits until 35 days after the last dose.

To evaluate the food effect on the pharmacokinetics of ZT006, participants who have received single dose of ZT006 or placebo of dose level 4 in the single dose-escalation study will receive another dose of ZT006 or placebo after a high fat, high caloric breakfast.

Conditions

• Overweight,Obesity

Interventions

DRUG

Placebo of ZT006

Participants will receive a single dose of placebo of ZT006 under fasted condition in period 1, and after a high fat, high caloric breakfast in period 2.

DRUG

Placebo of ZT006

Participants will receive daily doses of placebo of ZT006 for 42 days.

DRUG

ZT006

Participants will receive daily doses of ZT006 for 42 days: dose level 2 for 7 days, then dose level 3 for 7 days, then dose level 4 for 14 days, then dose level 5 for 14 days.

DRUG

Placebo of ZT006

Participants will receive a single dose of placebo of ZT006 under fasted condition.

DRUG

ZT006

Participants will receive a single dose of ZT006 of dose level 1 under fasted condition.

DRUG

ZT006

Participants will receive a single dose of ZT006 of dose level 2 under fasted condition.

DRUG

ZT006

Participants will receive a single dose of ZT006 of dose level 3 under fasted condition.

DRUG

ZT006

Participants will receive a single dose of ZT006 of dose level 4 under fasted condition in period 1, and after a high fat, high caloric breakfast in period 2.

DRUG

ZT006

Participants will receive a single dose of ZT006 of dose level 5 under fasted condition.

DRUG

ZT006

Participants will receive daily doses of ZT006 for 42 days: dose level 1 for 7 days, then dose level 2 for 7 days, then dose level 3 for 28 days.

DRUG

ZT006

Participants will receive daily doses of ZT006 for 42 days: dose level 1 for 7 days, then dose level 2 for 7 days, then dose level 3 for 14 days, then dose level 4 for 14 days.

DRUG

ZT006

Participants will receive daily doses of ZT006 for 42 days: dose level 2 for 7 days, then dose level 3 for 7 days, then dose level 4 for 28 days.

Sponsors & Collaborators

• Beijing QL Biopharmaceutical Co.,Ltd

  lead INDUSTRY

Principal Investigators

• Wei Hu, MD · The Second Hospital of Anhui Medical University

• Yijun Du, Master · The Second Hospital of Anhui Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-11-28

Primary Completion

2025-06-14

Completion

2025-06-24

Countries

• China

Study Locations