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

NCT06481475 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: YY003-001-US01
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Moderate to Severe Glabellar Lines

Keywords

YY003; Botulinum Toxin; Glabellar Lines

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Incidence of anti-drug antibodies and neutralizing antibodies

  Within 12 Weeks

Study Arms (3)

Low dose YY003

EXPERIMENTAL

Participants will receive a single dose over 5 injection sites on Day 1.

Biological: YY003

High dose YY003

EXPERIMENTAL

Participants will receive a single dose over 5 injection sites on Day 1.

Biological: YY003

Vehicle control

PLACEBO COMPARATOR

Participants will receive a single dose over 5 injection sites on Day 1.

Biological: Vehicle Control

Interventions

YY003 BIOLOGICAL

Single treatment, intramuscularly injected into five sites. The total injection volume is 0.25 ml, 0.05 ml per site.

High dose YY003; Low dose YY003

Vehicle Control BIOLOGICAL

Single treatment, intramuscularly injected into five sites. The total injection volume is 0.25 ml, 0.05 ml per site.

Vehicle control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants (male or female) must be ≥18 years old, at the time of signing the informed consent.
• 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.
• 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.
• Participant must provide signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Participant must have the time and ability to complete the study and comply with instructions, at the discretion of the investigator.

You may not qualify if:

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

Sponsors & Collaborators

• Chongqing Claruvis Pharmaceutical Co., Ltd.: lead

Study Sites (3)

St George Dermatology & Skin Cancer Centre

Sydney, New South Wales, 2217, Australia

RECRUITING

Skin Health Institute

Melbourne, Victoria, 3053, Australia

RECRUITING

Dermatology Institute of Victoria

Melbourne, Victoria, 3141, Australia

RECRUITING

Central Study Contacts

Pan Lin

CONTACT

+86 18183052779; pan.lin@claruvis.com

Sun Xiaoyun

CONTACT

+86 13810399273; sun.xiaoyun@claruvis.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: January 9, 2025
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)