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

Phase 1

Completed

• Conditions: Moderate to Severe Glabellar Lines
• Interventions: Biological: OnabotulinumtoxinA; Biological: YY001; Biological: Placebo

• Registration Number: NCT05743634
• Lead Sponsor: Chongqing Claruvis Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-22
• Status Verified: 2023-02
• Primary Completion: 2023-02-13
• Study Completion: 2023-02-13
• Study First Submitted: 2023-02-15
• Study First Submitted QC: 2023-02-15
• Last Update Submitted: 2023-02-15
• Study First Posted: 2023-02-24
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Male or female subjects from ≥18 to ≤65 years of age when signing an informed consent.
2. 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.
3. Agree to take part in the clinic trial and sign the informed consent form voluntarily.
4. Is able to observe the protocol by Investigator's assessment.
5. 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.

Exclusion Criteria

1. Known allergy or hypersensitivity to any component of the study products(YY001 or BOTOX®).
2. 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).
3. 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).
4. Use of any non-steroid anti-inflammatory drug or anticoagulant within 1 week prior to study treatment.
5. Use of medications that affect neuromuscular transmission within 4 weeks prior to screening, such as muscle relaxant,aminoglycoside antibiotics,anticholinergic drugs,benzodiazepines,etc.
6. Probably use of prohibited drug during the study,as assessed by the investigator.
7. Abnormal skin at in the treatment area,scar or physical scars, in the investigator's opinion,may interfere with study evaluations.
8. Inability to substantially spread glabellar lines apart by surgery or finger smoothing, as determined by the investigator.
9. Ptosis,excessive facial asymmetry and skin laxity ,at screening and baseline.
10. History of facial nerve palsy.
11. 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.
12. Any concomitant disease including,unfit for the study by the investigator.
13. In acute attack.
14. Abnormal lab findings,and unfit for the study in the opinion of the investigator.
15. History of alcohol or drug abuse.
16. History of epilepsy.
17. Any severe psychiatric illness ,in the investigator's opinion, could affect the subject's participation in the study.
18. Female who is pregnant,or breast feeding.
19. In any other clinical study ,or Participated in any other interventional study within 30 days or 5 half-lives prior to screening.
20. Contract research organization,study site personnel or close relatives of the study site personnel , employees or close relatives of employees at the sponsor company.
21. Other conditions, in the Investigator's opinion, unfit for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active-Controlled Group	OnabotulinumtoxinA	Single injection with BOTOX® in glabellar lines
Treatment Group	YY001	Single injection with YY001 in glabellar lines
Placebo-Controlled Group	Placebo	Single injection with placebo in glabellar lines

Primary Outcome Measures

Name	Time	Method
Phase1:The incidence rate of abnormal lab findings which have clinical significance within 28 days after injection	Within 28 days
Phase1:The incidence rate of adverse events and severe adverse events within 28 days after injection	Within 28 days
Phase2:The response rate will be evaluated at 28 days by investigator at maximum frown	28 days	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
Phase2:The incidence rate of injection site reaction within 12 weeks after injection	within 12 weeks
Phase1:The incidence rate of injection site reaction within 28 days after injection	Within 28 days
Phase2:The incidence rate of adverse events and severe adverse events within 12 weeks after injection	within 12 weeks

Trial Locations

Locations (6)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

West China Hospital,Sichuan University; 🇨🇳 Chengdu, Sichuan, China

The First affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

Nanfang Hospital,Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Shanghai Ninth People's Hospital,Shanghai JiaoTong University school of Medicine; 🇨🇳 Shanghai, Shanghai, China

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China