Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06402136 | Evaluation Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of 83-0060 in Healthy Volunteers | PHASE1 | COMPLETED | 57 | — | — | Apr 15, 2024 | Sep 30, 2024 | Jan 22, 2026 | 1 | Australia |
Incidence of Adverse Events observed during the study
Incidence of Adverse Events observed during the study deemed related to the study drug by the Investigator
Incidence of Serious Adverse Events observed during the study
Incidence of clinically relevant deviations in the clinical laboratory parameters
| Arm | Type | Description |
|---|---|---|
| Single dose level 1 or placebo | EXPERIMENTAL | Dose level 1. SAD study part. |
| Single dose level 2 or placebo | EXPERIMENTAL | Dose level 2. SAD study part. |
| Single dose level 3 or placebo | EXPERIMENTAL | Dose level 3. SAD study part. |
| Single dose level 4 or placebo | EXPERIMENTAL | Dose level 4. SAD study part. |
| Single dose level 5 or placebo | EXPERIMENTAL | Dose level 5. SAD study part. |
| Multiple dose level 1 or placebo | EXPERIMENTAL | Dose level 1. MAD study part. |
| Multiple dose level 2 or placebo | EXPERIMENTAL | Dose level 2. MAD study part. |
| Multiple dose level 3 or placebo | EXPERIMENTAL | Dose level 3. MAD study part. |
| Name | Type | Description |
|---|---|---|
| 83-0060 | DRUG | Oral MPro inhibitor |
| Placebo | DRUG | Placebo |
Inclusion Criteria: 1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. 2. Adult males and females, 18 to 65 years of age (inclusive) at...