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A Phase I Trial of Subcutaneous QLS7305 in Healthy Adults

NCT07313150 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-31

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary characteristics of the investigational drug QLS7305 in healthy adult participants in China. The main questions it aims to answer are:

What is the safety and tolerability profile of single and multiple subcutaneous doses of QLS7305 in healthy adults? What are the pharmacokinetic (PK) characteristics of QLS7305 and its major metabolites? What are the pharmacodynamic (PD) effects of QLS7305 on the complement system (e.g., serum C3 levels and complement activity)? Does QLS7305 induce an immunogenic response (anti-drug antibodies)? What is the effect of QLS7305 on the QTc interval? Investigators will compare different dose levels of QLS7305 to a placebo group to see the effects on safety, tolerability, and the measured parameters.

Participants will:

Be enrolled in one of two parts of the study:

Part A (Single Ascending Dose): Receive a single dose of QLS7305 or placebo. Part B (Multiple Ascending Dose): Receive multiple doses of QLS7305 or placebo (doses selected based on Part A results).

Receive prophylactic antibiotics (Penicillin V) after the first dose until their serum complement C3 level recovers, as a safety precaution.

Undergo close safety monitoring throughout the study, including a follow-up period of up to 337 days to ensure safety parameters return to acceptable levels.

Conditions

  • Healthy Volunteers - Male and Female

Interventions

DRUG

QLS7305 Injection

QLS7305 Injection

DRUG

Placebo Control

The placebo is a sterile solution that matches the appearance, volume, and packaging of the QLS7305 injection. It contains no active pharmaceutical ingredient and is administered subcutaneously following the same dosing schedule as the active comparator (single or multiple doses).

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhang Jing, Professor · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-12-31
Completion
2027-12-31

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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 NCT07313150 on ClinicalTrials.gov