A Study to Investigate the Safety and Efficacy of YY003 in Adults with Moderate to Severe Glabellar Lines

A Randomized Double-blind Vehicle-controlled Parallel-dose Phase II Study Evaluating the Safety and Efficacy of a Recombinant Botulinum Neurotoxin Type a Injection (YY003) for the Treatment of Moderate to Severe Glabellar Lines in Adults

The study is a two-part (Part A and Part B) randomized double-blind vehicle-controlled multi-center study in a total of 174 participants with moderate to severe glabellar lines. The objective of this study is to test the safety, efficacy, immunogenicity of YY003, and compare to vehicel control, in improving the appearance of moderate to severe glabellar lines.

Study Overview

• Status: Recruiting
• Conditions: Moderate to Severe Glabellar Lines
• Intervention / Treatment: Biological: YY003; Biological: Vehicle Control

• Study Type: Interventional
• Enrollment (Estimated): 174
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Pan Lin; Phone Number: +86 18183052779; Email: pan.lin@claruvis.com
• Study Contact Backup: Name: Sun Xiaoyun; Phone Number: +86 13810399273; Email: sun.xiaoyun@claruvis.com

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2217
      • Recruiting
      • St George Dermatology & Skin Cancer Centre
      • Contact: Hong; Phone Number: 0295874277; Email: ehon8261@med.usyd.edu.au
  • Victoria
    • Melbourne, Victoria, Australia, 3053
      • Recruiting
      • Skin Health Institute
      • Contact: Foley; Phone Number: 0396239400; Email: pfoley@skinhealthinstitute.org.au
    • Melbourne, Victoria, Australia, 3141
      • Recruiting
      • Dermatology Institute of Victoria
      • Contact: Goodman; Phone Number: (03) 9826 4966; Email: dermatology@div.net.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participants (male or female) must be ≥18 years old, at the time of signing the informed consent.
2. At screening and baseline, participants must have moderate to severe glabellar lines at maximum frown (grade 2 or 3 on the relevant 4-point scale), as assessed by both the investigator and the participant.
3. Male or female (inclusive of all gender identities) participants are eligible to participate if they agree to practice adequate contraceptive methods during the study period and for at least 3 months after the study drug administration. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
4. Participant must provide signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
5. Participant must have the time and ability to complete the study and comply with instructions, at the discretion of the investigator.

Exclusion Criteria:

1. Known allergy or hypersensitivity to any components of the investigational product or any botulinum toxin serotype.
2. A history or presence of ptosis, significant facial asymmetry, excessive dermatochalasis at screening or baseline.
3. A history or presence of facial nerve palsy at screening or baseline.
4. A positive HIV, hepatitis B or hepatitis C test at screening.
5. History or presence of other concomitant diseases which are assessed by the investigator to be unsuitable for participation in this clinical research.
6. History of drug or alcohol abuse.
7. History or presence of epilepsy.
8. Have a serious mental disorder that, in the Investigator's opinion, may affect participant compliance with the study.
9. Female who is pregnant or breast feeding.
10. Abnormal laboratory tests that, in the Investigator's assessment, are not appropriate for participation in this study.
11. Participation in an investigational device or drug study within 30 days or 5 half-lives (whichever is longer) prior to screening.
12. Study center personnel, close relatives of the study center personnel, employees or close relatives of employees at the sponsor company.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose YY003; Participants will receive a single dose over 5 injection sites on Day 1.	Biological: YY003; Single treatment, intramuscularly injected into five sites. The total injection volume is 0.25 ml, 0.05 ml per site.
Experimental: High dose YY003; Participants will receive a single dose over 5 injection sites on Day 1.	Biological: YY003; Single treatment, intramuscularly injected into five sites. The total injection volume is 0.25 ml, 0.05 ml per site.
Placebo Comparator: Vehicle control; Participants will receive a single dose over 5 injection sites on Day 1.	Biological: Vehicle Control; Single treatment, intramuscularly injected into five sites. The total injection volume is 0.25 ml, 0.05 ml per site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Satety: Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESI), and serious adverse events (SAEs)	within 4 weeks post-treatment
Efficacy: The proportion of participants achieving a score of 0 or 1 and at least a two-grade improvement from baseline, on both the investigator's assessment and the participant's self-assessmenti of glabellar line severity at maximum frown	at Week 4 post-treatment visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of anti-drug antibodies and neutralizing antibodies	Within 12 Weeks

Collaborators and Investigators

• Sponsor: Chongqing Claruvis Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2025
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Botulinum Toxin; Glabellar Lines; YY003
• Other Study ID Numbers: YY003-001-US01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No