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

NCT07178327 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-09-17

No results posted yet for this study

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).

Conditions

  • Osteoporotic Fracture

Interventions

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.

Sponsors & Collaborators

  • Shanghai TTM-Bio Technology Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Huan Zhou · The First Affiliated Hospital of Bengbu Medical University

  • Huan Zhou, Dr · The First Affiliated Hospital of Bengbu Medical University

  • Lin Zhen Zhang, Dr · Shanghai 6th People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-06
Primary Completion
2026-09-06
Completion
2027-09-06

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07178327 on ClinicalTrials.gov