Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Salbutamol Sulphate UD-DPI Blister · 1 trial · 1 indication
PK parameters include: area under the concentration-time curve from time zero (pre-dose) to 12 hours (hr) (AUC \[0-12hr\]) and/ or area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC \[0-infinity\]) and/ or area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC \[0-t\]) and maximum observed concentration (Cmax).
PK parameters include: AUC(0- infinity) or AUC(0-t) and Cmax
| Arm | Type | Description |
|---|---|---|
| Part A | EXPERIMENTAL | Subjects will receive following six treatments each in six period, with a 3-days minimum wash-out period, between each treatment period: 1) Single dose (SD) salbutamol (200mcg per blister from 1.6% blend) delivered via the UD-DPI by inhalation of 3 Blisters (BTR) giving a total dose of 600mcg; 2) SD salbutamol sulphate (200mcg per BTR from a 1.0% blend) delivered via the UD-DPI by inhalation of 3 BTR giving a total dose of 600mcg; 3) SD salbutamol (150mcg per BTR from a 1.6% blend) delivered via the UD-DPI by inhalation of 3 BTR giving a total dose of 450mcg; 4) SD salbutamol (250mcg per BTR from a 1.6% blend) delivered via the UD-DPI by inhalation of 3 BTR giving a total dose of 750mcg; 5) SD of salbutamol (200mcg per BTR) delivered via the Diskus by inhalation of 3 BTR giving a total dose of 600mcg; 6) SD salbutamol (100mcg per actuation) delivered via the MDI giving a total dose of 600mcg |
| Part B | EXPERIMENTAL | Prior to the start of Part B, a decision will be made regarding the UD-DPI products to be used in Part B. Subjects will receive following 6 treatments each in 6 period, with a 3-days minimum wash-out period, between each treatment period: 1) SD salbutamol (selected from Part A) delivered via the UD-DPI without activated charcoal (AC) by inhalation of 3 BTR (total dose dependant on UD-DPI formulation chosen); 2) SD salbutamol (selected from Part A) delivered via the UD-DPI with AC by inhalation of 3 BTR (total dose dependant on UD-DPI formulation chosen); 3) SD salbutamol by inhalation of 3 BTR (200mcg per BTR) delivered via the Diskus without AC (total dose 600mcg); 4) SD salbutamol by inhalation of 3 BTR (200mcg per BTR) delivered via the Diskus with AC (total dose 600mcg); 5) SD salbutamol 6 inhalations (100mcg) delivered via the MDI without AC (total dose 600mcg); 6) SD salbutamol 6 inhalations (100mcg) delivered via the MDI with AC (total dose 600mcg) |
| Name | Type | Description |
|---|---|---|
| Salbutamol Sulphate 150mcg UD-DPI Blister(1.6% blend) | DRUG | Salbutamol Sulphate 150mcg UD-DPI will be supplied as blister containing a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients |
| Salbutamol Sulphate 200mcg UD-DPI Blister(1.6% blend) | DRUG | Salbutamol Sulphate 200mcg UD-DPI will be supplied as blister containing a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients |
| Salbutamol Sulphate 250mcg UD-DPI Blister(1.6% blend) | DRUG | Salbutamol Sulphate 250mcg UD-DPI will be supplied as blister containing a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients |
| Salbutamol Sulphate 200mcg UD-DPI Blister(1% blend) | DRUG | Salbutamol Sulphate 200mcg UD-DPI will be supplied as blister containing a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients |
| Salbutamol Diskus 200mcg Blister | DRUG | Salbutamol Diskus 200mcg will be supplied as blister strip contained within the Diskus device. Each blister contains a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients |
| Salbutamol MDI 100mcg | DRUG | Salbutamol MDI 100mcg will be supplied as formulation of salbutamol sulphate (micronized) in propellant contained within the pressurised MDI device |
| Salbutamol Sulphate UD-DPI Blister (selected from Part A) | DRUG | Formulation will be determined depending on the outcome of Part A. |
| Salbutamol Sulphate 250mcg UD-DPI Blister (selected from Part A) | DRUG | Formulation will be determined depending on the outcome of Part A. |
| Salbutamol Diskus 200mcg Blister without activated charcoal | DRUG | Formulation will be determined depending on the outcome of Part A. |
| Salbutamol Diskus 200mcg Blister with activated charcoal | DRUG | Formulation will be determined depending on the outcome of Part A. |
| Salbutamol MDI 100mcg without activated charcoal | DRUG | Formulation will be determined depending on the outcome of Part A. |
| Salbutamol MDI 100mcg with activated charcoal | DRUG | Formulation will be determined depending on the outcome of Part A. |
Inclusion Criteria * Male/females aged between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Body weight \>=50 kg and body mass index within the range 19.0 - 34.0 kilogram per square meter (inclusive). * A female subject is eligible to participate if she is of: No...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 27 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | tilrekimig and rHuPH20, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
Salbutamol Sulphate UD-DPI Blister is being developed for the treatment of asthma. It is an investigational inhaled formulation of salbutamol sulphate delivered by a unit dose dry powder inhaler, and it has been studied in a Phase 1 clinical trial in healthy volunteers.
Salbutamol Sulphate UD-DPI Blister works as an agonist at the beta-2 adrenergic receptor, also known as ADRB2. Activation of this receptor in the airways produces bronchodilation, which helps relieve the airflow obstruction associated with asthma.
Salbutamol Sulphate UD-DPI Blister is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program for this inhaled asthma candidate.
Salbutamol Sulphate UD-DPI Blister is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 1 trial has been completed.
Salbutamol Sulphate UD-DPI Blister has been evaluated in one clinical trial, NCT01984086, a completed Phase 1 study that compared the pharmacokinetic profile of salbutamol delivered by unit dose dry powder inhaler with the Diskus and metered dose inhaler in 60 healthy volunteers in Australia.