FIH, Safety & PK Trial Assessing PIN201104 in HVs & Asthmatic Patients
Research type
Research Study
Full title
A First Time In Human, Randomised, Double Blind, Placebo Controlled, Parallel Group Study in Healthy Volunteers and Patients with Asthma to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending and Repeat Doses of PIN201104
IRAS ID
216388
Contact name
Muna Albayaty
Contact email
Sponsor organisation
Peptinnovate Ltd
Eudract number
2016-003735-38
Duration of Study in the UK
0 years, 7 months, 23 days
Research summary
This is a first-in-human, randomised, double-blind, placebo-controlled, parallel group clinical trial to assess the safety, tolerability and pharmacokinetics of single and repeated doses of the Sponsor’s study medication, PIN201104, in healthy volunteer subjects and patients with asthma.
The study will consist of four parts.
- Part A: multiple groups of healthy participants will be given a single intravenous dose (the study drug is administered into a vein) of PIN201104. This is the dose escalation part of the study.
- Part B: one group of healthy participants will be given 3 intravenous doses of PIN201104
- Part C: up to two groups of asthma patients will be given a single intravenous dose of PIN201104.
- Part D: one group of healthy participants will be given a single subcutaneous dose (the study drug is administered into the skin) of PIN201104.It is planned that in each cohort four subjects will be randomised to receive the active study drug (PIN201104) and two will receive dummy study drug (placebo). Additional subjects may be enrolled.
This will be the first time PIN201104 is administered in humans. It is being developed by Peptinnovate Ltd. for the treatment of inflammatory diseases, including respiratory diseases such as asthma and acute respiratory distress syndrome (ARDS). The standard treatment currently available for asthma does not limit disease progression. As such, there is a high unmet need for disease-modifying agents and/or more broad spectrum anti-asthmatic treatments.
The main purpose of the study is to see how safe the drug is and how well the body tolerates the drug after single and repeated doses. The study will also investigate the drug levels in the body over a period of time. The study will also look at effects of PIN201104 on exhaled nitric oxide measured in asthma patients, as well as on potential biomarkers.
REC name
London - Brent Research Ethics Committee
REC reference
16/LO/1876
Date of REC Opinion
18 Nov 2016
REC opinion
Further Information Favourable Opinion