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AZD5055 · 2 trials · 2 indications
The safety and the tolerability after single and multiple doses of AZD5055 in healthy Japanese and Chinese participants will be evaluated.
To investigate the safety and tolerability of AZD5055 by assessment of AEs (non-serious and serious) following administration of SAD
To investigate the safety and tolerability of AZD5055 by assessment of AEs (non-serious and serious) following administration of MAD
| Arm | Type | Description |
|---|---|---|
| AZD5055 | ACTIVE_COMPARATOR | Participants will orally receive AZD5055. |
| Placebo | PLACEBO_COMPARATOR | Participants will orally receive placebo. |
| Part 1 (single ascending doses [SAD]) | EXPERIMENTAL | Healthy participants will be randomized to a single dose of AZD5055 or placebo. |
| Part 2 (multiple ascending doses [MAD]) | EXPERIMENTAL | Healthy participants will be randomized to repeated dosing with AZD5055 or placebo |
| Name | Type | Description |
|---|---|---|
| AZD5055 | DRUG | AZD5055 will be given orally to randomized participants as per the arm they are assigned. |
| Placebo | DRUG | Placebo will be given orally to randomized participants as per the arm they are assigned. |
Inclusion Criteria: * For Chinese subjects only: 1. Participant was born in greater China, including Hong Kong, Macau, and Taiwan. 2. Participant has 2 Chinese biological parents and 4 Chinese grandparents as confirmed by interview. 3. Participant did not live outside of greater China for mo...
AZD5055 is an investigational small molecule being studied for idiopathic pulmonary fibrosis. It is currently in Phase 1 clinical development, with trials conducted in healthy participants to assess safety, tolerability, and pharmacokinetics. The drug is not yet approved and remains under investigation.
AZD5055 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and tolerability in healthy participants.
AZD5055 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trials are completed and focused on assessing safety, tolerability, and pharmacokinetics in healthy participants.
AZD5055 has been studied in two completed Phase 1 trials. NCT05134727 assessed safety, tolerability, and pharmacokinetics following single and multiple ascending doses in healthy participants. NCT05955183 evaluated the same parameters in Japanese and Chinese healthy volunteers. Both trials were conducted in the United States.
AZD5055 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trials focused on healthy participants to evaluate safety, tolerability, and pharmacokinetics. Further studies would be needed before any regulatory approval could be considered.