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AZD5634 for · 1 trial · 1 indication
To assess the safety and tolerability of AZD5634 in terms of number of participants following inhaled administration of single-ascending doses (SAD) (Part A) and following administration of single inhaled and IV doses (Part B)
| Arm | Type | Description |
|---|---|---|
| Part A, Dose Level 1 | EXPERIMENTAL | Subjects will inhale single doses of AZD5634 or placebo under fasted conditions and will rinse his/her mouth with approximately 100 mL (up to 240 mL) of water which must be swallowed |
| Part A, Dose Level 2 | EXPERIMENTAL | Subjects will inhale single doses of AZD5634 or placebo under fasted conditions and will rinse his/her mouth with approximately 100 mL (up to 240 mL) of water which must be swallowed |
| Part A, Dose Level 3 | EXPERIMENTAL | Subjects will inhale single doses of AZD5634 or placebo under fasted conditions and will rinse his/her mouth with approximately 100 mL (up to 240 mL) of water which must be swallowed |
| Part A, Dose Level 4 | EXPERIMENTAL | Subjects will inhale single doses of AZD5634 or placebo under fasted conditions and will rinse his/her mouth with approximately 100 mL (up to 240 mL) of water which must be swallowed |
| Part A, Dose Level 5 | EXPERIMENTAL | Subjects will inhale single doses of AZD5634 or placebo under fasted conditions and will rinse his/her mouth with approximately 100 mL (up to 240 mL) of water which must be swallowed |
| Part A, Dose Level 6 | EXPERIMENTAL | Subjects will inhale single doses of AZD5634 or placebo under fasted conditions and will rinse his/her mouth with approximately 100 mL (up to 240 mL) of water which must be swallowed |
| Part A, Dose Level 7 | EXPERIMENTAL | Subjects will inhale single doses of AZD5634 or placebo under fasted conditions and will rinse his/her mouth with approximately 100 mL (up to 240 mL) of water which must be swallowed |
| Part B, Dose Level 1 | EXPERIMENTAL | Subjects will receive a single dose of IV AZD5634 and after a washout period of 14 days the same subjects will receive a single dose of inhaled AZD5634 |
| Name | Type | Description |
|---|---|---|
| AZD5634 for inhalation | DRUG | Solution, citrate buffer, saline nebulizer solution; strength 0.1 - 5 mg/g; administered by jet nebulizer |
| AZD5634 for infusion | DRUG | Solution, citrate buffer, saline solution for infusion; strength 0.013 mg/mL |
| Placebo | OTHER | inactive substance |
Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Healthy male and/or female subjects aged 18 - 50 years with suitable veins for cannulation or repeated venipuncture. 3. Females must have a negative pregnancy test at screening ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | VX-121/TEZ/D-IVA |
| Sionna Therapeutics, Inc. | SION | 2 | PHASE2 | SION-719 |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-710 |
| Arcturus Therapeutics Holdings, Inc. | ARCT | 1 | PHASE2 | ARCT-032 |
| Krystal Biotech, Inc. | KRYS | 1 | PHASE1 | KB407 |
| Illumina, Inc. | ILMN | 1 | - | Undisclosed |
AZD5634 is an investigational small molecule being developed for cystic fibrosis and pulmonary or respiratory diseases. It is administered by inhalation and has been studied in adult patients with cystic fibrosis. The drug is still in clinical development and has not been approved by the FDA.
AZD5634 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the NASDAQ under the ticker symbol AZN. The drug is in Phase 1 clinical development for respiratory conditions including cystic fibrosis.
AZD5634 is in Phase 1 clinical development. It has completed two Phase 1 trials, one involving healthy volunteers and another in patients with cystic fibrosis. The drug is investigational and has not received FDA approval.
AZD5634 has completed two Phase 1 clinical trials. NCT02679729 assessed safety, tolerability, and pharmacokinetics after inhaled and intravenous dosing in healthy volunteers. NCT02950805 evaluated its effect on mucociliary clearance, safety, tolerability, and pharmacokinetics in patients with cystic fibrosis.
AZD5634 is the primary name for this investigational compound. No alternative names have been reported for this drug in clinical development.