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Also known as AZD5634 for inhalation
AZD5634 · 2 trials · 2 indications
Assessment of the average whole lung clearance between 0 and 60 minutes after administration of single inhaled dose of aerosolized radiolabelled particles (colloids) of AZD5634, (%MCC 0--60, whole) in subjects with cystic fibrosis (CF).
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 |
|---|---|---|
| Placebo + AZD5634 | EXPERIMENTAL | Subjects were administered single dose of placebo in period 1 and AZD5634 in period 2. |
| AZD5634 + Placebo | EXPERIMENTAL | Subjects were administered single dose of AZD5634 in period 1 and placebo in period 2. |
| 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 |
|---|---|---|
| Placebo | DRUG | Subjects will receive a placebo in either period 1 or period 2 by inhalation. |
| AZD5634 | DRUG | Subjects will receive a single tentative dose of 625 μg of AZD5634 in either period 1 or period 2 by inhalation. |
| 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 |
Inclusion Criteria: 1. Provision of signed and dated written informed consent prior to any study-specific procedures. 2. Male or female patients aged 18-60 years old inclusive. 3. Diagnosed of CF at Screening as evidenced in medical records by one of the following criteria: 1. sweat chloride ≥ ...
Top 6 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | Alyftrek, Trikafta, Ivacaftor, VX-581, VX-272 |
| 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 |
| Roivant Sciences Ltd. | ROIV | 1 | PHASE1 | SP-101 |
AZD5634 is an investigational small molecule developed by AstraZeneca PLC (ticker AZN) for cystic fibrosis and other pulmonary or respiratory diseases. It is given by inhalation and is in Phase 1 clinical development. It has been studied in trials assessing mucociliary clearance, safety, tolerability, and pharmacokinetic parameters.
AZD5634 is being studied in cystic fibrosis to assess its effect on mucociliary clearance, a key airway defense mechanism impaired in the disease. It is also being evaluated for safety, tolerability, and pharmacokinetic parameters in patients with cystic fibrosis. It remains investigational and is not approved for any indication.
AZD5634 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical trials evaluating the drug in cystic fibrosis and other pulmonary or respiratory diseases.
AZD5634 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA or any other regulatory agency. The completed Phase 1 trials enrolled a total of 63 participants across studies conducted in the United States.
AZD5634 has been evaluated in two completed Phase 1 trials: NCT02950805, which assessed its effect on mucociliary clearance, safety, tolerability, and pharmacokinetics in patients with cystic fibrosis, and NCT02679729, which assessed safety, tolerability, and pharmacokinetics after inhaled and intravenous dosing. Both trials were conducted in the United States.
Yes, AZD5634 for inhalation is an alternative name for AZD5634, reflecting its inhaled route of administration. The drug is also sometimes referred to as AZD5634 for. All refer to the same investigational small molecule developed by AstraZeneca for cystic fibrosis and pulmonary or respiratory diseases.