A Phase I Trial of Subcutaneous QLS7305 in Healthy Adults

NCT07313150 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: QLS7305-101
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

QLS7305; Double-stranded small interfering ribonucleic acid (siRNA) targeting complement; First-in-human; C3; SAD; MAD

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of TEAEs

  337 days

Secondary Outcomes (2)

• Plasma and urine concentrations of QLS7305

  337 days

• Relationship between plasma concentration of QLS7305 and the change in QTc interval.

  D3

Study Arms (2)

QLS7305

EXPERIMENTAL

QLS7305 Injection

Drug: QLS7305 Injection

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo Control

Interventions

QLS7305 Injection DRUG

QLS7305 Injection

Also known as: QLS7305

QLS7305

Placebo Control DRUG

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).

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 55 years (inclusive) Physical examination, vital signs, laboratory tests, 12-lead ECG, and imaging findings are within normal ranges.
• Body weight ≥50 kg for males and ≥45 kg for females, with a BM) between 18.0 and 28 kg/m² (inclusive).
• Willing or has complied with the administration of meningococcal and pneumococcal vaccines as required by the protocol.
• No plan to donate sperm or ova, no pregnancy plan, and voluntarily agrees to use effective contraception methods from the signing of the ICF until 12 months after administration of the investigational product.
• Able to understand and comply with the study procedures, voluntarily participate in the trial, and provide written informed consent.

You may not qualify if:

• History of food or drug allergy, and/or known allergy to GalNAc. History of definite infection with encapsulated bacteria within 6 months prior to screening.
• History of recurrent or chronic infection within 3 months prior to screening. Presence or suspicion of active viral, bacterial, fungal, or parasitic infection within 1 month prior to baseline.
• Any disease at screening that, in the investigator's judgment, could affect the study data.
• History of malignancy. Any condition that may affect drug absorption. History of splenectomy or congenital asplenia. History of congenital or acquired complement deficiency or disorder. History of allergic diseases (e.g., allergic asthma, allergic rhinitis).

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Officials

• Zhang Jing, Professor

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wu Cuiyun, Professor

CONTACT

021-5288 8921; wucuiyun@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 31, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 12 months after the primary publication and ending 5 years after the end of the study.
• Access Criteria: Individual participant data that underlie the results reported in this publication, after de-identification (text, tables, figures, and appendices) will be available. Proposals should be directed to jing16.wang@qilu-pharma.com. To gain access, data requestors will need to sign a data access agreement.