A Phase I/II Study of Recombinant Botulinum Toxin Type A for the Treatment of Moderate to Severe Glabellar Lines

NCT05743634 | Completed Phase 1 DMC

• 2 other identifiers: YY001-001CTR20221419
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 6

Brief Summary

This is a phase 1/2, multicenter, randomized, double-blind, active-controlled and placebo-controlled study to evaluate safety,immunogenicity and efficacy of YY001 for the treatment of moderate to severe glabellar lines in male and female subjects of Chinese origin. The study has been designed to test the safety,efficacy,immunogenicity of YY001,and compare to onabotulinumtoxinA (BOTOX®) and placebo, in improving the appearance of moderate to severe glabellar lines.

Conditions

Moderate to Severe Glabellar Lines

Keywords

YY001; Botulinum Toxin; Glabellar Lines

Outcome Measures

Primary Outcomes (6)

• Phase1:The incidence rate of adverse events and severe adverse events within 28 days after injection

  Within 28 days

• Phase1:The incidence rate of injection site reaction within 28 days after injection

  Within 28 days

• Phase1:The incidence rate of abnormal lab findings which have clinical significance within 28 days after injection

  Within 28 days

• Phase2:The response rate will be evaluated at 28 days by investigator at maximum frown

  A response rate is defined as a subject who achieves a score of 0 or 1 in GL severity at maximum frown and at least 2 grades improvement from baseline by investigator's assessment

  28 days

• Phase2:The incidence rate of adverse events and severe adverse events within 12 weeks after injection

  within 12 weeks

• Phase2:The incidence rate of injection site reaction within 12 weeks after injection

  within 12 weeks

Study Arms (3)

Treatment Group

EXPERIMENTAL

Single injection with YY001 in glabellar lines

Biological: YY001

Active-Controlled Group

ACTIVE COMPARATOR

Single injection with BOTOX® in glabellar lines

Biological: OnabotulinumtoxinA

Placebo-Controlled Group

PLACEBO COMPARATOR

Single injection with placebo in glabellar lines

Biological: Placebo

Interventions

YY001 BIOLOGICAL

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

Treatment Group

OnabotulinumtoxinA BIOLOGICAL

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

Active-Controlled Group

Placebo BIOLOGICAL

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

Placebo-Controlled Group

Eligibility Criteria

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

You may qualify if:

• Male or female subjects from ≥18 to ≤65 years of age when signing an informed consent.
• At screening and baseline,the subject has moderate to severe GL (grade of 2 or 3 on the 4-point Scale) at maximum frown when assessed by both the Investigator and the subject.
• Agree to take part in the clinic trial and sign the informed consent form voluntarily.
• Is able to observe the protocol by Investigator's assessment.
• Male and female of childbearing potential agree to use a highly effective contraceptive method for the duration of the study(such as tubal ligation,abstinence,Intrauterine device,hormone,barrier method).For female of childbearing potential,her blood pregnancy test is negative within 7 days prior to study treatment,and urine pregnancy test is negative within 3 days prior to study treatment.Male can't donate the sperm within 3 months after treatment.

You may not qualify if:

• Known allergy or hypersensitivity to any component of the study products(YY001 or BOTOX®).
• Previous use of any cosmetic therapy in the glabella or forehead area,such as hyaluronic acid,phototherapy,hydrating needle,microneedle,chemical peeling,scar removal surgery or skin dermabrasion within 6 months before screening.Previous use of biodegradable filler within 12 months before screening,such as collagen,polylactic acid or calcium hydroxyapatite.Previous use of autologous fat, any permanent products (such as silicone, polyacrylamide,no matter how long the interval is) ,face-lift,or semi-permanent prosthesis.Planned use of any cosmetic therapy in the glabella or forehead area during the study(other than the study products).
• Previous use of any botulinum toxin within 6 months prior to screening,or plan to use any botulinum toxin during the study(other than the study products).
• Use of any non-steroid anti-inflammatory drug or anticoagulant within 1 week prior to study treatment.
• Use of medications that affect neuromuscular transmission within 4 weeks prior to screening, such as muscle relaxant,aminoglycoside antibiotics,anticholinergic drugs,benzodiazepines,etc.
• Probably use of prohibited drug during the study,as assessed by the investigator.
• Abnormal skin at in the treatment area,scar or physical scars, in the investigator's opinion,may interfere with study evaluations.
• Inability to substantially spread glabellar lines apart by surgery or finger smoothing, as determined by the investigator.
• Ptosis,excessive facial asymmetry and skin laxity ,at screening and baseline.
• History of facial nerve palsy.
• Any medical condition that may interfere neuromuscular function including myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, dysphagia,dyspnea,diplopia,angle-closure glaucoma,eyelid or eyebrow ptosis,etc.
• Any concomitant disease including,unfit for the study by the investigator.
• In acute attack.
• Abnormal lab findings,and unfit for the study in the opinion of the investigator.
• History of alcohol or drug abuse.

Sponsors & Collaborators

• Chongqing Claruvis Pharmaceutical Co., Ltd.: lead

Study Sites (6)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

The First affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Nanfang Hospital,Southern Medical University

Guangzhou, Guangdong, China

Location

Shanghai Ninth People's Hospital,Shanghai JiaoTong University school of Medicine

Shanghai, Shanghai Municipality, China

Location

West China Hospital,Sichuan University

Chengdu, Sichuan, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Qingfeng Li

  Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Placebo and active controlled

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: February 24, 2023
• Study Start: March 22, 2022
• Primary Completion: February 13, 2023
• Study Completion: February 13, 2023
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)