HTL0022562 FIM SAD MAD trial to evaluate safety and tolerability
Research type
Research Study
Full title
A Phase 1, Randomised, Double-Blind, Placebo-Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dose and Multiple Ascending Doses of Subcutaneous HTL0022562 in Healthy Adult Subjects
IRAS ID
286033
Contact name
Pablo Forte Soto
Contact email
Sponsor organisation
Heptares Therapeutic Ltd.
Eudract number
2020-002887-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 6 days
Research summary
This is a first-in-human (FIH), Phase I, single-centre study in up to 88 healthy male subjects and female subjects of non-childbearing potential.
The main purpose of the study is to see how safe the IMP, HTL0022562, is and how well the body tolerates the IMP after single and repeated doses, administered subcutaneously. The study will also investigate how the IMP is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body) (overall referred to as pharmacokinetics [PK]). In addition, the impact of the IMP on genes of certain enzymes and transport proteins possibly implicated in the metabolism of HTL0022562 or on other genes playing a role in the response to HTL0022562 will be explored (“pharmacogenetics”).
The study comprises two parts. Single rising doses (Part 1, 56 subjects in 7 dose groups) and repeated daily doses over 7 days (Part 2, 32 subjects in 4 dose groups) will be administered to separate cohorts of healthy male and female (of non-child bearing potential) volunteers in a double-blind, randomised, placebo-controlled study design. The next higher doses will only be administered if the previous dose level was found to be safe.
Each study part includes a screening visit, treatment period and a follow-up visit. Eligible participants will stay inhouse for approximately 72 (Part 1) and 48 (Part 2) hours after the (last) dose.
HTL0022562 is being developed by Heptares Therapeutics Ltd. for the treatment of primary headache disorders such as cluster headache and migraine.
As this is the first study with HTL0022562 in men and women, no human safety data is available yet. Based on the nonclinical safety data, no clinically significant undesirable effects are expected.REC name
London - Brent Research Ethics Committee
REC reference
21/LO/0127
Date of REC Opinion
29 Mar 2021
REC opinion
Favourable Opinion