Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD8108 · 1 trial · 1 indication
Safety Laboratory - Thyroid Stimulating Hormone participants with laboratory value above the upper limit of normal
Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 after single/first dose of AZD8108
Pharmacokinetic : Area under the concentration curve (0 to 24 hour), AZD6765 MAD Day 6 dose of AZD8108 Cohort 5 \& 7, Cohort 6 did not reach Day 6
Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 MAD Day 12 dose of AZD8108 Cohort 5 \& 7, Cohort 6 did not reach Day 12
Pharmacokinetic : Area under the concentration curve (0 to 24 hours), AZD6765 after Day 12 dose of AZD8108 cohort 5 \& 7, Cohort 6 dod not reach Day 12
Pharmacokinetic : Maximum concentration of AZD6765 after single/first dose of AZD8108
Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 6 dose of AZD8108, Cohorts 5 \& 7, Cohort 6 did not reach Day 6
Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 12 dose of AZD8108, Cohorts 5 \& 7, Cohort 6 did not reach Day 12
| Arm | Type | Description |
|---|---|---|
| AZD8108 | EXPERIMENTAL | Subjects will participate in 1 of 7 groups and receive single or multiple doses of AZD8108 or matching placebo. In each group 6 subjects will receive AZD8108 |
| Placebo to match AZD8108 | PLACEBO_COMPARATOR | Subjects will participate in 1 of 7 groups and receive single or multiple doses of AZD8108 or matching placebo. In each group 2 subjects will receive matching placebo |
| Name | Type | Description |
|---|---|---|
| AZD8108 | DRUG | Drug: AZD8108 Single or Multiple doses administered orally as a solution. |
| Placebo | DRUG | Placebo to match AZD8108 Single or Multiple doses of matching placebo administered orally as a solution |
Inclusion Criteria: Inclusion Criteria: 1. Subjects must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-specific procedures. 2. Men and postmenopausal or surgically sterile women age 1...
AZD8108 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in early clinical development. The completed Phase 1 trial evaluated the drug in healthy adult participants to assess its safety, tolerability, and pharmacokinetics.
AZD8108 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the NASDAQ under the ticker symbol AZN. The company conducted a Phase 1 clinical trial of AZD8108 in the United States.
AZD8108 is in Phase 1 clinical development. The single Phase 1 trial, NCT02248818, has been completed. The drug is investigational and has not been approved by regulatory authorities. Its safety and efficacy have not been established.
AZD8108 has one completed Phase 1 clinical trial, NCT02248818, titled 'AZD8108 SAD/MAD in Healthy Volunteers'. This randomized, double-blind, placebo-controlled study enrolled 258 healthy volunteers in the United States and evaluated single and multiple ascending doses of the drug.
AZD8108 is not FDA approved. It is an investigational drug that has completed a Phase 1 trial in healthy volunteers. The drug remains in clinical development, and its safety and effectiveness for any medical condition have not been established.