Safety Clinical Trial
Official title:
AM1476 - A Phase I, Double-blind, Placebo-controlled, Single- and Multiple-oral Dose, Safety, Tolerability, and Pharmacokinetic Study in Healthy Subjects
This is a First in Human (FIH), double-blind, randomised, placebo-controlled study designed to evaluate safety, tolerability and PK of single and multiple ascending oral doses of AM1476 in healthy subjects.
Part A (SAD); In the SAD part of the study, single oral doses of AM1476 will be administered in up to 9 sequential groups, each consisting of 8 subjects randomised to recieve either AM1476 or placebo in a 3:1 ratio. The first 2 subjects in each group will be dosed in a sentinel fashion, 1 subject will receive AM1476 and the other will receive placebo as randomised. The SAD part incorporating a 2-period crossover arm for a food-effect evaluation in 2 groups. Part B (MAD); The MAD part of the study will explore multiple ascending dosing of AM1476 for 10 days. AM1476 will be administered in up to 6 sequential groups, each consisting of 8 subjects randomised to recieve either AM1476 or placebo in a 3:1 ratio. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05073744 -
Nalbuphine Versus Morphine for Perioperative Tumor Ablation
|
Phase 4 | |
Completed |
NCT03969641 -
Safety of RIV4 Versus IIV4 in Pregnant Women
|
Phase 4 | |
Completed |
NCT05592951 -
Safety and Tolerability of a Novel Amino-acid Based Hydration Drink in Healthy Volunteers
|
N/A | |
Completed |
NCT04693429 -
Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution+
|
Phase 1 | |
Completed |
NCT01636024 -
To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594
|
Phase 1 | |
Completed |
NCT01415102 -
A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.
|
Phase 1 | |
Completed |
NCT01243502 -
A Study to Assess the Pharmacokinetics, Safety and Tolerability of CT327 in Healthy Male Volunteers
|
Phase 1 | |
Completed |
NCT06072170 -
Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience
|
Phase 1 | |
Completed |
NCT05076253 -
Efficacy of Ivermectin in COVID-19
|
Phase 1/Phase 2 | |
Recruiting |
NCT06060379 -
Giochiamo 626 - Gaming for Health and Safety in Workplaces
|
N/A | |
Recruiting |
NCT05298800 -
Combined Immunization of COVID-19 Inactivated Vaccine With QIV and PPV23
|
Phase 4 | |
Completed |
NCT05188638 -
Safety of Ascending Single and Multiple Doses of Nebulised SoftOx Inhalation Solution in Healthy Subjects
|
Phase 1 | |
Completed |
NCT05145621 -
Oral Bio-equivalence Study
|
Phase 1 | |
Recruiting |
NCT05580159 -
New Generation mRNA Booster Vaccine Against Emerging VOCs
|
Phase 3 | |
Not yet recruiting |
NCT04596956 -
Safety and Efficacy of Sodium Bicarbonate Ringer Injection
|
Phase 4 | |
Completed |
NCT03033329 -
Single Dose Escalation and Multiple Dose Escalation Trial of an Intravenous Formulation of MRX-4
|
Phase 1 | |
Terminated |
NCT01929811 -
NeoMET Study in Neoadjuvant Treatment of Breast Cancer
|
Phase 2 | |
Completed |
NCT01193335 -
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.
|
Phase 4 | |
Completed |
NCT03300466 -
A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds
|
N/A | |
Active, not recruiting |
NCT05686161 -
mRNA Booster Vaccine(SW-BIC-213) Compared With Pfizer andSinopharm Against Emerging VOCs
|
Phase 3 |