Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MV-LASV · 1 trial · 1 indication
Rate of solicited and unsolicited adverse events (AEs) during the treatment period up to day 56
| Arm | Type | Description |
|---|---|---|
| MV-LASV low dose: treatment group A | EXPERIMENTAL | In total 24 participants will receive two low dose treatments with MV-LASV on day 0 and 28. |
| MV-LASV high dose: treatment group B | EXPERIMENTAL | In total 24 participants will receive two high dose treatments with MV-LASV on day 0 and 28. |
| Placebo: treatment group C | PLACEBO_COMPARATOR | In total 12 participants will receive placebo treatment on day 0 and 28. |
| Name | Type | Description |
|---|---|---|
| MV-LASV | BIOLOGICAL | The MV-LASV vaccine candidate is a recombinant live attenuated viral vectored vaccine, based on the backbone of the measles Schwarz virus strain for prophylaxis of Lassa infection and will be administered in two different dose levels by intra muscular (i.m.) injection. |
| Placebo | OTHER | A sterile physiological saline solution will be used as placebo to ensure blinding of the treatment with low dose MV-LASV and placebo within treatment group A. Additionally, the Placebo will be used as a control arm to enable comparison of treatment reactions within treatment groups B and C. |
Inclusion Criteria: 1. Signed informed consent obtained before any trial-related activities 2. Healthy men or women aged 18 to ≤ 55 years on the day of consenting 3. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with ...
MV-LASV is an investigational monoclonal antibody being developed for the prevention or treatment of Lassa virus infection. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
MV-LASV is being developed by Harmony Biosciences Holdings, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol HRMY.
MV-LASV is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. A Phase 1 trial has been completed, but the drug remains in early-stage clinical testing.
MV-LASV has been studied in one completed Phase 1 trial, NCT04055454, titled 'A Trial to Evaluate the Optimal Dose of MV-LASV (V182-001)'. This trial enrolled 60 participants in Belgium and included healthy volunteers.
MV-LASV is also known as V182-001, as indicated by the clinical trial title. Both names refer to the same investigational monoclonal antibody being developed for Lassa virus infection.