PLN-74809: Safety, tolerability and cardiodynamics of SAD
Research type
Research Study
Full title
A Continued Evaluation of the Safety, Tolerability, and Cardiodynamics of Single Ascending Doses of PLN-74809 in Healthy Participants.
IRAS ID
1006689
Contact name
Annie Clark
Contact email
Sponsor organisation
Pliant Therapeutics Inc
ISRCTN Number
ISRCTN67246142
Research summary
A double blind study to assess the safety, tolerability, and effect of the heart of a single ascending dose of the IMP (PLN-74809).The clinical trial investigational medicine, PLN-74809 is experimental. That means the Medicines and Health Care Regulatory Agency (MHRA) has not approved it for use outside the clinical trials. PLN-74809 is being studied to treat Idiopathic Pulmonary Fibrosis which is a condition in which tiny air sacs in the lungs become damaged, causing build-up of scar tissue and Primary Sclerosing Cholangitis which is a rare disease that attacks the bile ducts causing your liver bile ducts to become scarred. \nThe entire clinical trial duration is about 15 days plus up to 28 days for screening (running investigations on bloods, vital signs, ECG, etc.. to confirm eligibility of the participant to enrol into the study). There is a confinement period of about 8 days. There is 1 outpatient return visit to the clinic.\nEach volunteer will be enrolled into a specific dose level group. In each group, participants will be randomly assigned (by chance like flipping a coin) to receive PLN-74809 or placebo. Out of 60 subjects, 40 will receive PLN-74809 and 20 will receive placebo. A placebo is a tablet that looks like PLN-7408 but contains no investigational medicine. The use of a placebo helps to make sure that any side effects during the clinical trial are judged fairly. \nDose Level 1: 960 mg single dose of PLN-74809 or placebo\nDose Level 2: 1360 mg single dose of PLN-74809 or placebo\nDose Level 3: 1920 mg single dose of PLN-74809 or placebo\nDose Level 4: 2640 mg single dose of PLN-74809 or placebo\t\nDose Level 5: To be determined \nThe Clinical trial Doctor and the Sponsor will review the safety data of each dose level. The next dose level will not be dosed until the safety data has been reviewed. The Sponsor and/or the Clinical trial Doctor can stop the clinical trial at any time.
REC name
London - London Bridge Research Ethics Committee
REC reference
22/LO/0842
Date of REC Opinion
21 Mar 2023
REC opinion
Further Information Favourable Opinion