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NCT06194188
A Phase 2 Clinical Study of CU-20401
Phase 2 trial testing Subcutaneous injection of CU-20401 in Efficacy and Safety in 108 participants. Completed in 2 September 2024.
2 September 2024
Quick facts
| Lead sponsor | Cutia Therapeutics（Wuxi）Co.,Ltd |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 108 |
| Start date | 20 December 2023 |
| Primary completion | 2 September 2024 |
| Estimated completion | 2 September 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Subcutaneous injection of CU-20401 — full drug profile →
Conditions studied
- Efficacy and Safety — all drugs for Efficacy and Safety →
Sponsor
Cutia Therapeutics（Wuxi）Co.,Ltd — full company profile →
Who can join
Adults 18 to 65, any sex, with Efficacy and Safety. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a randomized, double-blind, placebo-controlled Phase Ⅱ clinical study to evaluate the efficacy, safety, and immunogenicity of CU-20401 for Injection in a population with moderate to severe contour elevation or over-fullness due to SMF accumulation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06194188
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Cutia Therapeutics（Wuxi）Co.,Ltd trials
Trials by the same sponsor.
- NCT06744569 — A Phase I Clinical Trial to Evaluate CU-10101 Unguent · Phase 1 · enrolling by invitation
- NCT06585696 — A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection (CU-20101) · Phase 3 · completed
- NCT05793892 — Efficacy and Safety of Lidocaine and Tetracaine Cream for Facial Laser Aesthetics in Chinese Adults · Phase 3 · completed
- NCT05380427 — A Phase I Clinical Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of CU-40101 Liniment in Single and Mu · Phase 1 · completed
- NCT05195541 — A Clinical Study to Evaluate the Safety, Pharmacokinetic Profile and Efficacy of CU-20401 · Phase 1, PHASE2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06194188 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cutia Therapeutics（Wuxi）Co.,Ltd
- Last refreshed: 22 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06194188.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing