NCT06493084

Evaluate LAE102 in Healthy and Overweight/Obese Subjects

A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Escalation Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LAE102 Injection in Healthy and Overweight/Obese Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Laekna Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of LAE102 injection in healthy and overweight/obese participants, and also evaluate the preliminary pharmacodynamic effect of multiple dose injections in overweight/obese participants.

Detailed description

Part A is a randomized, double-blinded, placebo-controlled, single ascending dose by Intravenous (IV) administration in 40 Healthy participants; Part B is a randomized, double-blinded, placebo-controlled, single ascending dose by subcutaneous (SC) administration in 24 Healthy participants; Part C is a randomized, double-blind, placebo-controlled, multiple dose ascending and expanding by subcutaneous (SC) administration in 60 overweight/obese participants.

Conditions

• Overweight and Obese Volunteers

Interventions

Type	Name	Description
DRUG	LAE102 intravenous administration	A single dose of LAE102 administered intravenously
DRUG	placebo intravenous administration	A single dose of placebo administered intravenously
DRUG	LAE102 subcutaneous administration	Single dose of LAE102 administered subcutaneously
DRUG	placebo subcutaneous administration	single dose of placebo administered subcutaneously
DRUG	LAE102 multiple subcutaneous administration	Multiple dose of LAE102 administered subcutaneously
DRUG	Placebo multiple subcutaneous administration	Multiple dose of placebo administered subcutaneously

Timeline

• Start date: 2024-06-25
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2024-07-09
• Last updated: 2026-01-09

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study