NCT07178327

Phase I Clinical Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of LYN101

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Administration of LYN101 in Healthy Subjects and Multiple Administrations in Postmenopausal Women With Low Bone Mass

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Shanghai TTM-Bio Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, two-part, first-in-human, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of LYN101 in healthy subjects (part A) and multiple doses in postmenopausal women with low bone mass (part B).

Detailed description

The study includes Part A and Part B. Up to four dose levels will be tested in the single ascending dose stage, involving approximately 32 healthy volunteer subjects, with eight subjects per dose level (Part A). After completing Part A, one dose level or additional optional levels will be tested in multiple doses in Part B, enrolling about 12 postmenopausal women with low bone mass. In both Part A and Part B, eligible subjects will be randomized in a 3:1 ratio to receive either LYN101 or a matched placebo.

Conditions

• Osteoporotic Fracture

Interventions

Type	Name	Description
DRUG	LYN101	In Part A, participants will receive single dose of LYN101 administered as a subcutaneous (SC) injection. In Part B, participants will receive multiple doses of LYN101 administered as a SC injection.
DRUG	Placebo	In Part A, participants will receive single dose of the matched placebo administered as a subcutaneous (SC) injection (4 cohorts). In Part B, participants will receive multiple doses of the matched placebo administered as a SC injection.

Timeline

• Start date: 2025-09-06
• Primary completion: 2026-09-06
• Completion: 2027-09-06
• First posted: 2025-09-17
• Last updated: 2025-09-17

Locations

2 sites across 1 country: China