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Also known as NCO-48 Fumarate
NCO-48 · 2 trials · 2 indications
An adverse event is defined as any untoward medical occurrence in a clinic investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. The severity of all adverse events will be graded according to the CTCAE version 4.0 from dosing until 30 days post dose.
Time-weighted average change from baseline through Week 4 in plasma HBV DNA (log10 IU/mL) for NCO-48 Fumarate 4 and 20-mg.
| Arm | Type | Description |
|---|---|---|
| NCO-48 Fumarate | EXPERIMENTAL | NCO-48 Fumarate |
| Placebo | PLACEBO_COMPARATOR | Placebo Comparator |
| NCO-48 Fumarate 4 mg | EXPERIMENTAL | Eligible subjects will be randomized 1:1:1 to receive either open-label NCO-48 Fumarate 4 mg or 20 mg, or open-label TAF 25 mg for 28 days. |
| NCO-48 Fumarate 20 mg | EXPERIMENTAL | Eligible subjects will be randomized 1:1:1 to receive either open-label NCO-48 Fumarate 4 mg or 20 mg, or open-label TAF 25 mg for 28 days. |
| Tenofovir alafenamide 25 mg | ACTIVE_COMPARATOR | Eligible subjects will be randomized 1:1:1 to receive either open-label NCO-48 Fumarate 4 mg or 20 mg, or open-label TAF 25 mg for 28 days. |
| Name | Type | Description |
|---|---|---|
| NCO-48 Fumarate | DRUG | NCO-48 Fumarate |
| Placebo | DRUG | Placebo |
| NCO-48 Fumarate 4 mg | DRUG | 2 x 2mg NCO-48 Fumarate over 28 days of therapy |
| NCO-48 Fumarate 20 mg | DRUG | 2 x 10 mg NCO-48 Fumarate over 28 days of therapy |
| Tenofovir Alafenamide 25 mg | DRUG | 25 mg over 28 days of therapy |
Inclusion Criteria: 1. Healthy male or female subjects 21 to 65 years of age, inclusive. 2. Female subjects of non-childbearing potential must be surgically sterile or postmenopausal, defined as spontaneous amenorrhea for at least 2 years with follicle-stimulating hormone (FSH) in the post-menopaus...
NCO-48 is an investigational small molecule developed by Ligand Pharmaceuticals Incorporated for chronic hepatitis B and hepatitis B. It has been studied in Phase 1 clinical trials in the United States. NCO-48 is not approved and remains in clinical development.
NCO-48 is being developed for the treatment of chronic hepatitis B and hepatitis B. It is an investigational therapy and has not been approved for any indication. Clinical testing has been limited to Phase 1 studies evaluating its activity, safety, tolerability, and pharmacokinetics.
NCO-48 is developed by Ligand Pharmaceuticals Incorporated, which trades under the ticker LGND. The company is the sponsor of the clinical program studying NCO-48 in hepatitis B and chronic hepatitis B.
NCO-48 is in Phase 1 clinical development. Two Phase 1 trials have been completed: one in treatment-naive adults with chronic hepatitis B and one in healthy subjects. NCO-48 is investigational and has not been approved by the FDA.
NCO-48 has been studied in two completed Phase 1 trials. NCT04629976 evaluated NCO-48 fumarate in treatment-naive adults with chronic hepatitis B, enrolling 21 participants. NCT04309526 assessed safety, tolerability, and pharmacokinetics in 48 healthy subjects. Both trials were conducted in the United States.
Yes, NCO-48 Fumarate and NCO-48 Fumarate 4 mg are alternative names for NCO-48. The fumarate salt form is the version studied in clinical trials, including NCT04629976 and NCT04309526.