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NOT YET RECRUITING
NCT07861581
PHASE1

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of QLS2312 Injection

Sponsor: Shanghai Qilu Pharmaceutical Research and Development Center LTD

View on ClinicalTrials.gov

Summary

This study is a first-in-human Phase 1 clinical study conducted in healthy adult participants in China to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of QLS2312 Injection after single and multiple subcutaneous administrations. The study consists of Part A and Part B: Part A is a single-ascending-dose study, and Part B is a multiple-ascending-dose (MAD) study.

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of QLS2312 Injection in Chinese Healthy Adult Participants

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2026-11-11

Completion Date

2027-11-20

Last Updated

2026-10-06

Healthy Volunteers

Yes

Interventions

DRUG

QLS2312 Injection

QLS2312 Injection to be administered by SC injection

DRUG

Placebo

Placebo solution to be administered at a matching volume by SC injection