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NCT01724814: HM12460A
A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM12460A
Phase 1 trial testing HM12460A in Healthy in 86 participants. Completed in 1 July 2014.
1 July 2014
Quick facts
| Lead sponsor | Hanmi Pharmaceutical Company Limited |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 86 |
| Start date | 20 December 2012 |
| Primary completion | 1 July 2014 |
| Estimated completion | 1 July 2014 |
| Sites | 1 location across United States |
Drugs / interventions tested
- HM12460A — full drug profile →
- Placebo
Conditions studied
- Healthy — all drugs for Healthy →
- Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →
- Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →
Sponsor
Hanmi Pharmaceutical Company Limited — full company profile →
Who can join
Adults 18 to 70, any sex, with Healthy or Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Study Design: Part 1.Randomized, double-blind, placebo-controlled, escalating single-dose design with Healthy volunteers Part 2.Open , sequential, two-period, single dose study with type 1 diabetes Part 3.Open, sequential, two-period, single dose study with type 2 diabetes
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 NCT01724814
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HM12460A
Trials testing the same drug.
- NCT03332836 — Multiple Ascending Dose Study of HM12460A in Type 2 Diabetes Mellitus · Phase 1 · terminated
- NCT03330314 — Molar Potency Study of HM12460A in Healthy Subjects · Phase 1 · completed
Other recruiting trials for Healthy
Currently open trials in the same condition.
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- NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting
Other Hanmi Pharmaceutical Company Limited trials
Trials by the same sponsor.
- NCT07297693 — A Study to Evaluate the Pharmacokinetics and Safety Between HIP2503 and HCP1306 in Healthy Volunteers · Phase 1 · not yet recruiting
- NCT06595004 — A Study to Evaluate the Efficacy and Safety of HCP1004 in Chronic Low-Back Pain Patients · Phase 3 · completed
- NCT06518122 — A Study to Evaluate the Drug-drug Interaction and Safety Between HCP1306, RLD2302 and RLD2102 in Healthy Volunteers · Phase 1 · completed
- NCT06481098 — A Phase 1 Study to Assess HM15275 in Healthy and Obese Subjects. · Phase 1 · completed
- NCT06357910 — A Study to Evaluate the Pharmacokinetics and Safety Between HCP2303 and Co-administration of Each Component in Healthy V · Phase 1 · 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 NCT01724814 (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 Hanmi Pharmaceutical Company Limited
- Last refreshed: 8 November 2017
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/NCT01724814.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing