NCT06908707

A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE102 in Postmenopausal Women

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Phase 1 Study to Determine the Safety, Tolerability and Pharmacokinetics of LAE102 in Healthy Postmenopausal Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Laekna Limited · Industry
• Sex: Female
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of LAE102 in healthy postmenopausal women

Detailed description

This is a placebo-controlled single ascending dose by subcutaneous (SC) and Intravenous (IV) administration in healthy postmenopausal women to assess the safety and tolerability of LAE102. At least 32 healthy female participants will be enrolled in 4 cohorts with each cohort including 8 participants randomized 6:2 LAE102:Placebo.

Conditions

• Postmenopausal
• Healthy Adult Female Participants

Interventions

Type	Name	Description
DRUG	LAE102 SC	A single dose of LAE102 will be administered subcutaneously
DRUG	Placebo SC	A single dose of placebo administered subcutaneously
DRUG	LAE102 IV	A single dose of LAE102 administered intravenously
DRUG	Placebo IV	A single dose of placebo administered intravenously

Timeline

• Start date: 2025-04-22
• Primary completion: 2025-10-23
• Completion: 2025-10-23
• First posted: 2025-04-03
• Last updated: 2025-11-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study