Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GS-4321 · 1 trial · 1 indication
AUC is defined as the area under the concentration versus time curve
Cmax is defined as the maximum observed concentration of drug.
Tmax is defined as the time (observed time point) of Cmax.
Combined Response is defined as undetectable hepatitis delta virus (HDV) RNA or ≥ 2 log10 decrease in HDV RNA from baseline and normal alanine aminotransferase (ALT) normalization (ALT \< upper limit of normal (ULN) at week 24).
| Arm | Type | Description |
|---|---|---|
| Phase 1: GS-4321 | EXPERIMENTAL | Participants will receive single escalating doses of GS-4321. |
| Phase 1: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo to match the single escalating doses of GS-4321 |
| Phase 2: GS-4321 | EXPERIMENTAL | Participants will receive multiple escalating doses of GS-4321 up to 96 weeks. |
| Name | Type | Description |
|---|---|---|
| GS-4321 | DRUG | Administered subcutaneous (SC) or intravenously IV |
| GS-4321 Placebo | DRUG | Administered SC |
Key Inclusion Criteria: Part A: * Participants assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. * Have a body mass index (BMI) of ≤ 30.0 kg/m2 at screening and at admission. P...
GS-4321 is an investigational small molecule being developed for the treatment of chronic hepatitis delta, a serious liver infection caused by the hepatitis D virus. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
GS-4321 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
GS-4321 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is currently recruiting participants to assess the drug's safety and tolerability.
GS-4321 is being studied in a Phase 1 clinical trial with the identifier NCT07096193. This trial is titled 'Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus' and is currently recruiting up to 200 participants across multiple countries.
GS-4321 is a unique investigational compound and is not known to be the same as any other marketed drug. It is a small molecule being developed specifically for chronic hepatitis delta, and no alternative names have been associated with this asset in its development program.