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NCT04699669
A Phase 1 Study to Evaluate the Safety and Tolerability of CBL-514 Injection on Convexity or Fullness of Abdominal Subcutaneous Fat in Healthy Volunteers
Phase 1 trial testing CBL-514, placebo in Subcutaneous Fat in 40 participants. Completed in 20 August 2019.
20 August 2019
Quick facts
| Lead sponsor | Caliway Biopharmaceuticals Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 27 November 2018 |
| Primary completion | 20 August 2019 |
| Estimated completion | 20 August 2019 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- CBL-514, placebo — full drug profile →
- CBL-514, placebo — full drug profile →
- CBL-514 — full drug profile →
Conditions studied
- Subcutaneous Fat — all drugs for Subcutaneous Fat →
Sponsor
Caliway Biopharmaceuticals Co., Ltd. — full company profile →
Who can join
Adults 18 to 64, any sex, with Subcutaneous Fat. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Phase 1 component of the study is a double-blind, placebo-controlled, single ascending dose (SAD) design intended to assess the safety, tolerability, and PK of CBL-514. The SAD part will involve 9 proposed dosing cohorts.
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 NCT04699669
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CBL-514
Trials testing the same drug.
- NCT05234736 — A Study to Evaluate the Pharmacokinetic Profile of CBL-514 Injection in Healthy Volunteers · Phase 2 · completed
- NCT04575467 — A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 1) · Phase 2 · completed
- NCT04698642 — A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of CBL-514 Injection for Reducing Convexity or Fu · Phase 2 · completed
Other Caliway Biopharmaceuticals Co., Ltd. trials
Trials by the same sponsor.
- NCT06005441 — A Phase 2b Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat. · Phase 2 · completed
- NCT05736107 — A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat · Phase 2 · completed
- NCT05836779 — A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With EFP; Cellulite (Stage 2) · Phase 2 · completed
- NCT05632926 — A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With EFP; Cellulite (Stage 1) · Phase 2 · completed
- NCT05387733 — A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With Dercum's Disease Lipomas · Phase 2 · 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 NCT04699669 (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 Caliway Biopharmaceuticals Co., Ltd.
- Last refreshed: 7 January 2021
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/NCT04699669.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing